All times are listed in CEST (Central European Summer Time)

Displaying One Session

Mini Oral session
Date
Mon, 20.09.2021
Time
17:30 - 18:30
Location
Channel 1
Mini Oral session

LBA12 - Predictive value of gene-expression profiles (GEPs) and their dynamics during therapy in the NeoTRIPaPDL1 trial

Presentation Number
LBA12
Speakers
  • Giampaolo Bianchini (Milan, Italy)
Lecture Time
17:30 - 17:38
Session Name
Location
Channel 1, Paris Expo Porte de Versailles, Paris, France
Date
Mon, 20.09.2021
Time
17:30 - 18:30

Abstract

Background

GEPs may reveal pathways associated with pathological complete response (pCR) in TNBC treated with neoadjuvant immunotherapy combination.

Methods

In NeoTRIP patients with TNBC were randomized to eight cycles of nab-paclitaxel/carbo (CT) with/without atezolizumab (CTA). 258 patients were evaluable for pCR. RNA-sequencing performed pre-treatment (n=242/258; 93.8%) and on treatment on day 1 of cycle 2 (excluding samples without tumor cells) (d1c2; n=161/258; 62.4%). We evaluated the association with pCR of the 27-gene IO score, TNBCtypes (BL1, BL2, LAR, M and MSL; Ring et al 2016), and selected tumor intrinsic and extrinsic gene-signatures. Within pCR group, super-responders were those with no tumor cells at d1c2 (33.3% in CTA; 16.5% in CT). Analyses were adjusted for baseline PD-L1 and sTILs.

Results

Pre-treatment, binary IO score was predictive of pCR in CTA (OR 3.64 [1.68-7.90], p=0.001), but not in the CT arm (1.31 [0.64-2.67] (p=0.46) (interaction p=0.029). Among TNBCtypes, the LAR subtype had the lowest pCR rate (CTA 22.2%, CT 18.8%), and BL1 had the highest (CTA 70.3%, CT 54.3%) (p=0.001) (Interactions not significant). High angiogenesis and fatty acid/cholesterol were independently linked to resistance in CTA, but not CT, arm (interaction p=0.005 and p=0.02, respectively). Only in CTA arm, super-responders were also characterized by high expression of some immune-signatures. At d1c2, high expression of several immune-related signatures were similarly predictive of pCR in both arms (p<0.01), whereas glutamine metabolism was linked to resistance in CTA arm only. For instance, high CD8 (above median) was associated with 58.6% and 61.7% pCR rate in CTA and CT arm, respectively, but low CD8 with only 22% and 23.1%. Combination of both baseline value and dynamic of some biomarkers was more informative than either one alone.

Conclusions

IO score, but not TNBCtype, is predictive of atezolizumab benefit over CT alone. Angiogenesis and lipid/glutamine metabolism were linked to resistance, suggesting new potential therapeutic targets. Super-responders in atezolizumab arm have a unique biology and represent ideal candidates to treatment de-escalation. Early biomarker dynamics provide additional predictive information.

Clinical trial identification

NCT02620280.

Legal entity responsible for the study

Fondazione Michelangelo.

Funding

Roche.

Disclosure

G. Bianchini: Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Invited Speaker: Lilly; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Invited Speaker: Neopharm Israel; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Invited Speaker: Chugai; Financial Interests, Personal, Invited Speaker: Daiichi Sankyo; Financial Interests, Personal, Invited Speaker: EISAI; Financial Interests, Personal, Training: MSD; Financial Interests, Personal, Training: Pfizer; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Advisory Board: Daiichi Sankyo; Financial Interests, Personal, Advisory Board: Lilly; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: Genomic Health; Financial Interests, Personal, Advisory Board: Eisai; Financial Interests, Personal, Advisory Board: Amgen; Financial Interests, Personal, Advisory Board: Sanofi; Financial Interests, Personal, Other, travel grants: Roche; Financial Interests, Personal, Other, travel grants: Pfizer; Financial Interests, Personal, Other, travel grants: AstraZeneca; Financial Interests, Personal, Other, travel grants: Eisai. C. Huang: Financial Interests, Personal, Invited Speaker: Amgen; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Advisory Role: AstraZeneca; Financial Interests, Personal, Invited Speaker: Eli Lilly; Financial Interests, Personal, Advisory Role: Eli Lilly; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Advisory Role: Novartis; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Advisory Role: Pfizer; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Institutional, Research Grant: Eli Lilly; Financial Interests, Institutional, Research Grant: Pfizer; Financial Interests, Institutional, Research Grant: Novartis; Financial Interests, Institutional, Research Grant: EirGenix; Financial Interests, Institutional, Research Grant: OBI Pharma; Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Institutional, Research Grant: MSD; Financial Interests, Institutional, Research Grant: Daiichi Sankyo; Financial Interests, Institutional, Research Grant: Roche; Non-Financial Interests, Personal, Advisory Role: Roche; Non-Financial Interests, Personal, Advisory Role: Eli Lilly; Non-Financial Interests, Personal, Advisory Role: EirGenix; Non-Financial Interests, Personal, Advisory Role: OBI trials; Non-Financial Interests, Personal, Leadership Role: Taiwan Breast Cancer Consortium. D. Egle: Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Other, travel grant: Pfizer; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Advisory Board: Daiichi Sankyo; Financial Interests, Personal, Advisory Board: Myriad. B. Bermejo: Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Advisory Role: Novartis; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Advisory Role: Pfizer; Financial Interests, Personal, Invited Speaker: Lilly; Financial Interests, Personal, Advisory Role: Lilly; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Advisory Role: MSD; Financial Interests, Personal, Invited Speaker: Palex; Financial Interests, Personal, Invited Speaker: AstraZeneca; Other, Personal, Member of the Board of Directors: Geicam. R.S. Seitz: Financial Interests, Personal, Full or part-time Employment: OncoCyte; Financial Interests, Personal, Stocks/Shares: OncoCyte. T.J.J. Nielsen: Financial Interests, Personal, Full or part-time Employment: OncoCyte; Financial Interests, Personal, Stocks/Shares: OncoCyte. C. Zamagni: Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Other, travel accommodation: Roche; Financial Interests, Personal, Advisory Board: Eisai; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Other, travel accommodation: Novartis; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Other, travel accommodation: Pfizer; Financial Interests, Personal, Advisory Board: PharmaMar; Financial Interests, Personal, Other, travel accommodation: PharmaMar; Financial Interests, Personal, Advisory Board: Amgen; Financial Interests, Personal, Advisory Board: Tesaro; Financial Interests, Personal, Other, travel accommodation: Tesaro; Financial Interests, Personal, Advisory Board: QuintilesIMS; Financial Interests, Personal, Other, travel accommodation: Pierre Fabre; Financial Interests, Personal, Other, travel accommodation: Istituto Gentili; Financial Interests, Personal, Advisory Board: Lilly; Financial Interests, Personal, Advisory Board: Celgene; Financial Interests, Personal, Other, travel accommodation: Celgene; Financial Interests, Institutional, Funding, research funding: Roche; Financial Interests, Institutional, Funding, research funding: Novartis; Financial Interests, Institutional, Funding, research funding: AstraZeneca; Financial Interests, Institutional, Funding, research funding: Pfizer; Financial Interests, Institutional, Funding, research funding: SeattleGenetics; Financial Interests, Institutional, Funding, research funding: Tesaro; Financial Interests, Institutional, Funding, research funding: PierreFabre; Financial Interests, Institutional, Funding, research funding: Istituto Gentili; Financial Interests, Institutional, Funding, research funding: Takeda; Financial Interests, Institutional, Funding, research funding: TEVA; Financial Interests, Institutional, Funding, research funding: Medivation; Financial Interests, Institutional, Funding, research funding: AbbVie; Financial Interests, Institutional, Funding, research funding: Array BioPharma; Financial Interests, Institutional, Funding, research funding: Morphotek; Financial Interests, Institutional, Funding, research funding: Synthon; Non-Financial Interests, Personal, Leadership Role: Europa Donna italy, Susan J Komen Emilia-Romagna, LOTO Onlus, Mamazone Sudtirol; Non-Financial Interests, Personal, Member: Europa Donna italy, Susan J Komen Emilia-Romagna, LOTO Onlus, Mamazone Sudtirol. M. Thill: Financial Interests, Personal, Invited Speaker: Amgen; Financial Interests, Personal, Advisory Board: Amgen; Financial Interests, Personal, Other, travel expenses: Amgen; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Other, travel expenses: AstraZeneca; Financial Interests, Personal, Advisory Board: Daiichi Sankyo; Financial Interests, Personal, Other, travel expenses: Daiichi Sankyo; Financial Interests, Personal, Invited Speaker: Eisai; Financial Interests, Personal, Advisory Board: Eisai; Financial Interests, Personal, Other, travel expenses: Eisai; Financial Interests, Personal, Invited Speaker: Exact Sciences; Financial Interests, Personal, Advisory Board: Exact Sciences; Financial Interests, Personal, Funding: Exact Sciences; Financial Interests, Personal, Other, travel expenses: Exact Sciences; Financial Interests, Personal, Invited Speaker: Lilly; Financial Interests, Personal, Advisory Board: Lilly; Financial Interests, Personal, Other, travel expenses: Lilly; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Other, travel expenses: MSD; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Other, travel expenses: Novartis; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Other, travel expenses: Pfizer; Financial Interests, Personal, Advisory Board: Pierre-Fabre; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Writing Engagements: Roche; Financial Interests, Personal, Other, travel expenses: Roche; Financial Interests, Personal, Advisory Board: GSK; Financial Interests, Personal, Invited Speaker: Hexal; Financial Interests, Personal, Other, travel expenses: Hexal; Financial Interests, Personal, Advisory Board: Seagen; Financial Interests, Personal, Invited Speaker: Seagen; Financial Interests, Personal, Invited Speaker: Vifor; Financial Interests, Personal, Advisory Board: Vifor; Financial Interests, Personal, Other, travel expenses: Vifor; Financial Interests, Personal, Advisory Board: Biom'Up; Financial Interests, Personal, Advisory Board: ClearCut; Financial Interests, Personal, Writing Engagements: ClearCut; Financial Interests, Personal, Advisory Board: pfm medical; Financial Interests, Personal, Invited Speaker: pfm medical; Financial Interests, Personal, Writing Engagements: pfm medical; Financial Interests, Personal, Other, travel expenses: pfm medical; Financial Interests, Personal, Invited Speaker: Celgene; Financial Interests, Personal, Advisory Board: Celgene; Financial Interests, Personal, Other, travel expenses: Celgene; Financial Interests, Personal, Invited Speaker: Clovis; Financial Interests, Personal, Advisory Board: Clovis; Financial Interests, Personal, Other, travel expenses: Clovis; Financial Interests, Personal, Project Lead, trial funding: Exact Sciences; Non-Financial Interests, Personal, Leadership Role: Scientific Subboard German Breast Group; Non-Financial Interests, Personal, Member of the Board of Directors: AWOgyn; Non-Financial Interests, Personal, Leadership Role: BLFG; Non-Financial Interests, Personal, Leadership Role: OncoNet Rhein-Main. A. Anton: Financial Interests, Personal, Advisory Board: Bayer Spain; Financial Interests, Personal, Expert Testimony: Pfizer; Financial Interests, Personal, Advisory Board: Roche; Non-Financial Interests, Personal, Member: GEICAM; Non-Financial Interests, Personal, Member: TTD group (Spanish Digestive Tumor Treatment Group); Non-Financial Interests, Personal, Member: ECO Foundation . E.M. Ciruelos: Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Speaker’s Bureau: Roche; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Invited Speaker: Lilly; Financial Interests, Personal, Speaker’s Bureau: Lilly; Financial Interests, Personal, Advisory Board: Lilly; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: Daiichi Sankyo; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Institutional, Funding: Pfizer; Financial Interests, Institutional, Funding: MSD; Financial Interests, Institutional, Funding: PUMA; Financial Interests, Institutional, Funding: Roche; Non-Financial Interests, Personal, Member of the Board of Directors: SOLTI Cooperative Group; Non-Financial Interests, Personal, Advisory Role: Instituto de Salud Carlos III. B.L. Schweitzer: Financial Interests, Personal, Full or part-time Employment: OncoCyte; Financial Interests, Personal, Stocks/Shares: OncoCyte. R. Greil: Financial Interests, Personal, Advisory Role: Celgene; Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Advisory Role: Merck; Financial Interests, Personal, Advisory Role: Takeda; Financial Interests, Personal, Advisory Role: AstraZeneca; Financial Interests, Personal, Advisory Role: Novartis; Financial Interests, Personal, Advisory Role: Amgen; Financial Interests, Personal, Advisory Role: BMS; Financial Interests, Personal, Advisory Role: MSD; Financial Interests, Personal, Advisory Role: Sandoz; Financial Interests, Personal, Advisory Role: AbbVie; Financial Interests, Personal, Advisory Role: Gilead; Financial Interests, Personal, Advisory Role: Daiichi Sankyo; Financial Interests, Institutional, Funding, Research Funding: Celgene; Financial Interests, Institutional, Funding, Research Funding: Roche; Financial Interests, Institutional, Funding, Research Funding: Merck; Financial Interests, Institutional, Funding, Research Funding: Takeda; Financial Interests, Institutional, Funding, Research Funding: AstraZeneca; Financial Interests, Institutional, Funding, Research Funding: Novartis; Financial Interests, Institutional, Funding, Research Funding: Amgen; Financial Interests, Institutional, Funding, Research Funding: BMS; Financial Interests, Institutional, Funding, Research Funding: MSD; Financial Interests, Institutional, Funding, Research Funding: Sandoz; Financial Interests, Institutional, Funding, Research Funding: AbbVie; Financial Interests, Institutional, Funding, Research Funding: Gilead; Financial Interests, Institutional, Funding, Research Funding: Daiichi Sankyo; Other, Personal, Other, Travel expenses, accomodations: Celgene, Roche, Merck, Takeda, AstraZeneca, Novartis, Amgen, BMS, MSD, Sandoz, AbbVie, Gilead, Daiichi Sankyo. G. Viale: Financial Interests, Personal, Advisory Board: Roche Genetech; Financial Interests, Personal, Advisory Board: MSD Oncology; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Advisory Board: Daichii Sankyo; Financial Interests, Personal, Advisory Board: Ventana; Financial Interests, Personal, Advisory Board: Dako Agilent; Financial Interests, Personal, Advisory Role: Menarini; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Role: AstraZeneca; Financial Interests, Institutional, Other, Research contract: Roche; Financial Interests, Institutional, Other, Research contract: Cepheid; Financial Interests, Institutional, Other, Research contract: Dako Agilent; Financial Interests, Institutional, Other, Research contract: Ventana. M. Callari: Financial Interests, Personal, Advisory Role: Novartis. L. Gianni: Financial Interests, Personal, Advisory Board: ADC Therapeutics; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: Celgene; Financial Interests, Personal, Advisory Board: Eli Lilly; Financial Interests, Personal, Advisory Board: G1 Therapeutics; Financial Interests, Personal, Advisory Board: Genentech; Financial Interests, Personal, Advisory Board: Genomic Health; Financial Interests, Personal, Advisory Board: Merck Sharp & Dohme; Financial Interests, Personal, Advisory Board: Oncolytics Biotech; Financial Interests, Personal, Advisory Board: Odonate Therapeutics; Financial Interests, Personal, Advisory Role: Odonate Therapeutics; Financial Interests, Personal, Advisory Board: Onkaido Therapeutics; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Other, travel support: Pfizer; Financial Interests, Personal, Advisory Board: Taiho Pharmaceutical; Financial Interests, Personal, Advisory Board: Hexal Sandoz; Financial Interests, Personal, Advisory Board: Seattle Genetics; Financial Interests, Personal, Advisory Board: Synthon; Financial Interests, Personal, Advisory Board: Zymeworks; Financial Interests, Personal, Advisory Role: Zymeworks; Financial Interests, Personal, Advisory Board: Sanofi Aventis; Financial Interests, Personal, Advisory Role: Forty Seven (CD47); Financial Interests, Personal, Advisory Role: Genenta; Financial Interests, Personal, Advisory Role: METIS Precision Medicine; Financial Interests, Personal, Advisory Role: Novartis; Financial Interests, Personal, Advisory Role: Revolution Medicines; Financial Interests, Personal, Advisory Role: Synaffix; Financial Interests, Personal, Advisory Role: Menarini Ricerche; Financial Interests, Personal, Advisory Role: Amgen; Financial Interests, Personal, Advisory Role: Biomedical Insights Inc; Financial Interests, Institutional, Funding, Support for research projects: Zymeworks; Financial Interests, Institutional, Funding, Support for research projects: Revolution Medicines; Other, Personal, Other, Co-Inventor of “European Patent Application N. 12195182.6 and 12196177.5” titled “PDL-1 expression in anti-HER2 therapy”- Roche - Issued- No compensation provided: Roche. All other authors have declared no conflicts of interest.

Collapse
Mini Oral session

120MO - Prognostic value of immune gene-expression signatures (iGES) vs tumor-infiltrating lymphocytes (TILs) in early-stage HER2+ breast cancer: A combined analysis of CALGB 40601 (C40601) and PAMELA trials

Presentation Number
120MO
Speakers
  • Aranzazu Fernandez-Martinez (Chapel Hill, United States of America)
Lecture Time
17:38 - 17:43
Session Name
Location
Channel 1, Paris Expo Porte de Versailles, Paris, France
Date
Mon, 20.09.2021
Time
17:30 - 18:30

Abstract

Background

TILs and iGES are associated with pathologic complete response (pCR) and relapse-free survival (RFS) in HER2+ breast cancer, however they have typically not been compared. Here we examine the prognostic value of iGES vs. TILs, alone and together, in two different HER2+ neoadjuvant trials: the chemotherapy plus HER2-targeting trial C40601, and the all-biologic trial PAMELA.

Methods

Gene expression profiling by mRNA sequencing (RNAseq) and TILs (per 2014 TILs working group) as a continuous variable were assessed on 230 C40601 and 139 PAMELA pre-treatment samples. iGES scores were calculated by extracting the median expression of all genes within a signature. Association with pCR and RFS was studied by logistic regression and Cox analyses. To compare the goodness of fit of different models, we used the Akaike Information Criterion (AIC). To compare the prognostic ability of two nested models, we used the Likelihood-Ratio test (LRT).

Results

Every 1% increase in TILs was associated with a significant 1% increase in the odds of pCR in C40601 (odds ratio [OR] 1.01, p < 0.01) and a 2% increase in PAMELA (OR 1.02, p = 0.04). TILs were not associated with RFS at 7 years in C40601 (Hazard ratio [HR] 0.99, p = 0.21). Of the 210 iGES tested, 130 (61.9%) were correlated with TILs across the 2 trials (p < 0.05), and 13 iGES were also significantly associated with higher pCR rates in both studies (ORs range 1.05-2.33, p < 0.05). 11 of 13 iGES outperformed TILs for pCR prediction, 7 of which were B-cell-related iGES. In a multivariate Cox model including clinical factors and PAM50 subtype, 8 of these iGES, but not TILS, were independently associated with RFS (iGES HRs range 0.56-0.72, p values < 0.05; TILs HR 0.99, p = 0.38).

Conclusions

In C40601 and PAMELA, multiple, mostly B-cell-related, iGES performed better than TILs for pCR prediction. In C40601, TILs did not provide additional RFS information to clinical parameters, subtype, and multiple GES. When both TILs and iGES are available, the prognostic value of RNA-based signatures is superior.

Clinical trial identification

CALGB-40601: NCT00770809; SOLTI 1114-PAMELA: NCT01973660. CALGB is part of the Alliance for Clinical Trials in Oncology.

Legal entity responsible for the study

The authors.

Funding

BCRF, Susan G Komen, NCI SPORE (P50-CA58823), R01-CA229409 and Alliance U10CA180821(LAC, CMP). Instituto de Salud Carlos III - PI16/00904 (AP), Pas a Pas (AP), Save the Mama (AP), Breast Cancer Now - 2018NOVPCC1294 (AP). Becas FSEOM para Formación en Investigación en Centros de Referencia en el Extranjero 2018 (TP). https://acknowledgments.alliancefound.org.

Disclosure

I. Krop: Financial Interests, Stocks/Shares: AMAG Pharmaceuticals; Financial Interests, Stocks/Shares: Freeline Therapeutics; Financial Interests, Stocks/Shares: Vertex; Financial Interests, Other: Genentech; Financial Interests, Other: Seattle Genetics; Financial Interests, Other: Daiichi Sankyo; Financial Interests, Other: Macrogenics; Financial Interests, Other: Taiho Pharmaceutical; Financial Interests, Other: Context Therapeutics; Financial Interests, Other: Novartis, Merck; Financial Interests, Other: ION Pharma; Financial Interests, Other: Bristol Myers Squibb; Financial Interests, Other: Pfizer . A. Partridge: Financial Interests, Royalties: UpToDate. A. Prat: Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Invited Speaker: Amgen; Financial Interests, Personal, Invited Speaker: BMS; Financial Interests, Personal, Invited Speaker: Nanostring Technologies; Financial Interests, Personal, Invited Speaker: Daiichi Sankyo; Financial Interests, Institutional, Other: Boehringer Ingelheim; Financial Interests, Institutional, Other: Novartis; Financial Interests, Institutional, Other: Roche; Financial Interests, Institutional, Other: Nanostring Technologies; Financial Interests, Institutional, Other: Sysmex Europa; Financial Interests, Institutional, Other: GmbH; Financial Interests, Institutional, Other: Medica Scientia inno. Research; Financial Interests, Institutional, Other: Celgene; Financial Interests, Institutional, Other: Astellas; Financial Interests, Institutional, Other: Pfizer; Financial Interests, Institutional, Other: Lilly; Financial Interests, Institutional, Other: Amgen; Financial Interests, Institutional, Other: Daiichi Sankyo; Financial Interests, Leadership Role: Reveal Genomics; Financial Interests, Leadership Role: BIG; Financial Interests, Leadership Role: SOLTI. L.A. Carey: Financial Interests, Institutional, Other: Innocrin Pharma; Financial Interests, Institutional, Other: Syndax; Financial Interests, Institutional, Other: Immunomedics; Financial Interests, Institutional, Other: Novartis; Financial Interests, Institutional, Other: NanoString Technologies; Financial Interests, Institutional, Other: AbbVie; Financial Interests, Institutional, Other: Seattle Genetics. C.M. Perou: Financial Interests, Other: GeneCentric; Financial Interests, Other: Bioclassifier; Financial Interests, Other: NanoString Technologies; Financial Interests, Other: Veracyte; Financial Interests, Royalties: PAM50. All other authors have declared no conflicts of interest.

Collapse
Mini Oral session

LBA13 - Predictive impact of biomarkers on pCR and survival after de-escalated neoadjuvant T-DM1 with or without endocrine therapy (ET) vs. trastuzumab+ET in HER2+/HR+ early breast cancer: WSG ADAPT TP trial

Presentation Number
LBA13
Speakers
  • Nadia Harbeck (Munich, Germany)
Lecture Time
17:43 - 17:48
Session Name
Location
Channel 1, Paris Expo Porte de Versailles, Paris, France
Date
Mon, 20.09.2021
Time
17:30 - 18:30

Abstract

Background

HER2+/HR+ EBC is a distinct entity associated with different molecular and clinical features compared to HER2+/HR- EBC. ADAPT TP showed promising pCR rates of 40% after only 4x T-DM1 +/- endocrine therapy (ET) which also corresponded to excellent 5y outcome. Optimal patient selection for de-escalation in HER2+/HR+ EBC is still an unsolved question.

Methods

WSG TP phase II-trial is part of the ADAPT umbrella (NCT 01779206): 375 patients (pts) with HR+/HER2+ EBC were randomized to 12 weeks of T-DM1 with/without ET vs. trastuzumab+ET q3w. Chemotherapy (CT) omission was allowed in all pts with pCR after study treatment. Primary endpoint was pCR (ypT0/is/ypN0). Secondary endpoints include safety, 5y iDFS and OS, translational research. A 3-week biopsy assessed early response defined as Ki67 decrease (vs. baseline) of ≥ 30% or low cellularity (<500 tumor cells). TILs and IHC immune markers (CD8, PD1, PDL1), PI3K mutation status and gene expression (RNA) by a custom 800-gene codeset (nCounter platform; Nanostring Technologies, Inc., Seattle, WA) were assessed on baseline samples.

Results

Baseline IHC expression of CD8 (HR 0.61; 0.36-1.01; p=0.052), of PD-L1ic (HR 0.32; 0.10-1.07; p=0.065) and CD8 expression by mRNA (HR 0.66; 0.47-0.92; p=0.015) but not TILs were associated with a decreased iDFS risk. In T-DM1 arms, PIK3CAmut (HR 3.66; 1.33-10.06; p=0.012) was significantly associated with increased iDFS risk. Those 55% luminal A subtype-patients (vs. others) had improved outcome (5y iDFS 96% vs. 83%; HR 0.50; 0.23-1.08; p=0.079) despite their rather low pCR rate of 25%. In multivariate analysis, clinical nodal burden was significantly associated with poor iDFS, while ESR1 and CD8 gene expression were favorable factors.

Conclusions

In HER2+/HR+ EBC, tumor immunogenicity at baseline is associated with improved survival. Poor outcome associated with PIK3CAmut cannot be overcome by T-DM1. HER2+/HR+ tumors are driven by HER2 and ER; this heterogeneous biology needs to be considered for future de-escalation concepts. Beyond pCR, trials in luminal A tumors should focus on survival as an endpoint.

Clinical trial identification

NCT01779206.

Legal entity responsible for the study

West German Study Group - WSG.

Funding

West German Study Group - WSG, Roche.

Disclosure

N. Harbeck: Financial Interests, Personal, Advisory Role: Agendia, AstraZeneca , BMS, Celgene, Daiichi Sankyo, Genomic Health, Eli Lilly, MSD, Novartis, Odonate, Pierre Fabre, Pfizer, Roche, Sandoz/Hexal, Seattle Genetics; Financial Interests, Personal, Other, Lectures: Amgen, AstraZeneca, Daiichi, Eli Lilly, MSD, Novartis, Pierre Fabre, Pfizer, Roche, Seattle Genetics; Financial Interests, Personal, Stocks/Shares: WSG; Financial Interests, Institutional, Principal Investigator, all directly to my institution (clinical phase II-IV trials): several sponsors; Financial Interests, Institutional, Sponsor/Funding, clinical phase II-IV trials: several sponsors; Non-Financial Interests, Personal, Leadership Role: AGO breast commission (Germany). U. Nitz: Financial Interests, Personal and Institutional, Funding: Agendia; Financial Interests, Personal and Institutional, Funding: Amgen; Financial Interests, Personal and Institutional, Funding: Celgene; Financial Interests, Personal and Institutional, Funding: Genomic Health/Exact Sciences; Financial Interests, Personal and Institutional, Funding: Nanostring; Financial Interests, Personal and Institutional, Funding: Roche; Financial Interests, Personal and Institutional, Funding: Sanofi; Financial Interests, Personal, Funding: Pfizer; Financial Interests, Personal, Stocks/Shares: WSG. S. Kuemmel: Financial Interests, Personal, Advisory Role: AstraZeneca; Financial Interests, Personal, Advisory Role: Celgene; Financial Interests, Personal, Advisory Role: Daiichi Sankyo; Financial Interests, Personal, Advisory Role: Genomic Health/Exact Sciences; Financial Interests, Personal, Advisory Role: Lilly; Financial Interests, Personal, Advisory Role: MSD; Financial Interests, Personal, Advisory Role: Novartis; Financial Interests, Personal, Advisory Role: Seagen; Financial Interests, Personal, Advisory Role: Pfizer; Financial Interests, Personal, Advisory Role: pfm Medical; Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Advisory Role: Somatex; Financial Interests, Personal, Stocks/Shares: WSG; Financial Interests, Institutional, Principal Investigator: diverse studies. M. Braun: Financial Interests, Personal, Advisory Role: AstraZeneca; Financial Interests, Personal, Advisory Role: Exact Sciences; Financial Interests, Personal, Advisory Role: Novartis; Financial Interests, Personal, Funding: Pfizer; Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Funding: Teva; Financial Interests, Personal, Funding: MSD; Financial Interests, Personal, Advisory Role: Puma. W. Malter: Financial Interests, Personal, Advisory Role: Genomic Health/Exact Sciences; Financial Interests, Personal, Advisory Role: Novartis. B. Aktas: Financial Interests, Personal, Sponsor/Funding: Pfizer; Financial Interests, Personal, Sponsor/Funding: Roche; Financial Interests, Personal, Sponsor/Funding: Merck Sharp & Dome; Financial Interests, Personal, Sponsor/Funding: onkowissen.de; Financial Interests, Personal, Sponsor/Funding: Novartis; Financial Interests, Personal, Sponsor/Funding: AstraZeneca; Financial Interests, Personal, Sponsor/Funding: PharmaMar; Financial Interests, Personal, Sponsor/Funding: Lilly; Financial Interests, Personal, Sponsor/Funding: Promedicis. C. Kolberg-Liedtke: Financial Interests, Personal, Sponsor/Funding: diverse sponsors; Financial Interests, Personal, Funding: Roche; Financial Interests, Personal, Funding: Novartis; Financial Interests, Personal, Funding: Pfizer; Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Advisory Role: Novartis; Financial Interests, Personal, Advisory Role: Pfizer; Financial Interests, Personal, Advisory Role: Celgene; Financial Interests, Personal, Advisory Role: Phaon Scientific. S. de Haas: Financial Interests, Personal, Full or part-time Employment: Roche. R.J. Deurloo: Financial Interests, Personal, Full or part-time Employment: Roche. R.E. Kates: Financial Interests, Personal, Advisory Role: WSG. C. Eulenburg zu: Financial Interests, Personal, Full or part-time Employment: WSG. R. Wuerstlein: Financial Interests, Personal, Other, Served as advisor, consultant, speaker and travel grant: Agendia, Amgen, Aristo, AstraZeneca , Boehringer Ingelheim, Carl Zeiss, Celgene, Clinsol, Daiichi Sankyo, Eisai, Exact Sciences, Genomic Health, Gilead, Glaxo Smith Kline, Hexal, Lilly, Medstrom Medical, MSD, Mundipharma, Nanostring, Novartis, Odonate, P. O. Gluz: Financial Interests, Personal, Advisory Role: Genomic Health/Exact Sciences; Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Advisory Role: Celgene; Financial Interests, Personal, Advisory Role: Pfizer; Financial Interests, Personal, Advisory Role: Novartis; Financial Interests, Personal, Sponsor/Funding: Nanostring; Financial Interests, Personal, Sponsor/Funding: AstraZeneca; Financial Interests, Personal, Advisory Role: Lilly; Financial Interests, Personal, Advisory Role: MSD. All other authors have declared no conflicts of interest.

Collapse
Mini Oral session

Discussion LBA12, 120MO and LBA13

Speakers
  • Marleen Kok (Amsterdam, Netherlands)
Lecture Time
17:48 - 17:58
Session Name
Location
Channel 1, Paris Expo Porte de Versailles, Paris, France
Date
Mon, 20.09.2021
Time
17:30 - 18:30
Mini Oral session

LBA14 - Neoadjuvant giredestrant (GDC-9545) + palbociclib (palbo) vs anastrozole (A) + palbo in post-menopausal women with oestrogen receptor-positive, HER2-negative, untreated early breast cancer (ER+/HER2– eBC): Interim analysis of the randomised, open-label, phase II coopERA BC study

Presentation Number
LBA14
Speakers
  • Sara A. Hurvitz (Seattle, CA, United States of America)
Lecture Time
17:58 - 18:03
Session Name
Location
Channel 1, Paris Expo Porte de Versailles, Paris, France
Date
Mon, 20.09.2021
Time
17:30 - 18:30

Abstract

Background

Endocrine therapy is the mainstay for ER+ BC while CDK4/6 inhibitors + A decrease Ki67 expression (a proliferation biomarker). Giredestrant, a highly potent, nonsteroidal, oral, selective ER antagonist and degrader (SERD), achieves robust ER occupancy, is well tolerated and has encouraging anti-tumour activity as monotherapy and in combination with palbo in metastatic BC. coopERA BC (NCT04436744) investigates giredestrant vs A (both + palbo) in post-menopausal women with ER+/HER2– eBC. We present an interim analysis.

Methods

Patients (pts) with measurable cT1c (≥1.5 cm)–cT4a–c ER+/HER2– eBC and baseline Ki67 score ≥5% are randomised 1:1 to 1 mg oral daily (PO QD) A or 30 mg PO QD giredestrant on Days (D)1–14 (window-of-opportunity [WOO] phase; 14D) followed by QD dosing for four 28-D cycles + 125 mg PO palbo on D1–21 (neoadjuvant phase; 16 weeks) pre-surgery. Stratification factors: T status; Ki67 score; progesterone receptor status. Primary efficacy endpoint: Centrally assessed geometric mean relative Ki67 score change from baseline to Week 2 during the WOO phase (scores reflect endocrine therapies’ ability to suppress proliferation; a surrogate clinical outcomes marker). Complete cell cycle arrest rate (CCCA; pts with Ki67 score ≤2.7%) at Week 2 is a secondary efficacy endpoint. Safety is also assessed.

Results

83/202 planned pts were assessed. Two-week relative Ki67 reduction was greater with giredestrant (reduction from baseline to Week 2 geometric mean = 80%; 95% CI = 72%, 85%) than A (67%; 95% CI = 56%, 75%; P = 0.0222). Consistent Ki67 suppression was observed in pts with baseline Ki67 ≥20% (giredestrant: 83% reduction; A: 71%) or <20% (65% vs 24%). At Week 2, 25% of tumours exhibited CCCA with giredestrant vs 5% with A (Δ 20%; 95% CI = –37%, –3%). Fewer pts had giredestrant- vs A-related adverse events (AEs) (28% vs 38%); no grade ≥3 AEs or serious AEs were giredestrant-related.

Conclusions

Interim analysis data demonstrated superior anti-proliferative activity of giredestrant compared with A. Safety was consistent with the known giredestrant profile.

Clinical trial identification

NCT04436744.

Editorial acknowledgement

Medical writing support for this abstract, furnished by Daniel Clyde, PhD, and Bonnie Jordan, BSc, of Health Interactions, was funded by F. Hoffmann-La Roche Ltd.

Legal entity responsible for the study

F. Hoffmann-La Roche Ltd.

Funding

F. Hoffmann-La Roche Ltd.

Disclosure

S.A. Hurvitz: Financial Interests, Institutional, Research Grant, Contracted research: Ambrx; Financial Interests, Institutional, Research Grant, Contracted research: Amgen; Financial Interests, Institutional, Research Grant, Contracted research: AstraZeneca; Financial Interests, Institutional, Research Grant, Contracted research: Arvinas; Financial Interests, Institutional, Research Grant, Contracted research: Bayer; Financial Interests, Institutional, Research Grant, Contracted research: Daiichi Sankyo; Financial Interests, Institutional, Research Grant, Contracted research: Genentech/Roche; Financial Interests, Institutional, Research Grant, Contracted research: Gilead; Financial Interests, Institutional, Research Grant, Contracted research: GSK; Financial Interests, Institutional, Research Grant, Contracted research: Immunomedics; Financial Interests, Institutional, Research Grant, Contracted research: Lilly; Financial Interests, Institutional, Research Grant, Contracted research: Macrogenics; Financial Interests, Institutional, Research Grant, Contracted research: Novartis; Financial Interests, Institutional, Research Grant, Contracted research: Pfizer; Financial Interests, Institutional, Research Grant, Contracted research: OBI Pharma; Financial Interests, Institutional, Research Grant, Contracted research: Pieris; Financial Interests, Institutional, Research Grant, Contracted research: PUMA; Financial Interests, Institutional, Research Grant, Contracted research: Radius; Financial Interests, Institutional, Research Grant, Contracted research: Sanofi; Financial Interests, Institutional, Research Grant, Contracted research: Seattle Genetics; Financial Interests, Institutional, Research Grant, Contracted research: Dignitana; Financial Interests, Institutional, Research Grant, Contracted research: Zymeworks; Financial Interests, Institutional, Research Grant, Contracted research: Phoenix Molecular Designs, Ltd; Financial Interests, Personal, Other, Travel (2019): Lilly; Financial Interests, Personal, Stocks/Shares, Spouse: Ideal Implant; Financial Interests, Personal, Stocks/Shares: NKMax; Non-Financial Interests, Personal, Research Grant, Medical writing support: F. Hoffmann-La Roche Ltd. Y.H. Park: Non-Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Institutional, Research Grant, Contracted research: AstraZeneca; Non-Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Institutional, Research Grant, Contracted research: Pfizer; Non-Financial Interests, Institutional, Principal Investigator, Contracted research: AstraZeneca; Non-Financial Interests, Institutional, Principal Investigator, Contracted research: Pfizer; Non-Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Institutional, Research Grant, Contracted research: Roche; Non-Financial Interests, Institutional, Principal Investigator, Contracted research: Roche; Financial Interests, Personal, Other, Speaker fee: Roche; Non-Financial Interests, Institutional, Principal Investigator, Contracted research: Daiichi Sankyo; Non-Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Other, Speaker fee: Novartis; Non-Financial Interests, Institutional, Principal Investigator, Contracted research: Novartis; Non-Financial Interests, Personal, Advisory Board: Merck; Financial Interests, Institutional, Research Grant, Contracted research: Merck; Non-Financial Interests, Institutional, Principal Investigator, Contracted research: Merck; Non-Financial Interests, Personal, Research Grant, Medical writing support: F. Hoffmann-La Roche Ltd. A. Bardia: Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: Genentech; Financial Interests, Personal, Advisory Board: Merck; Financial Interests, Personal, Advisory Board: Radius Health; Financial Interests, Personal, Advisory Board: Immunomedics; Financial Interests, Personal, Advisory Board: Taiho; Financial Interests, Personal, Advisory Board: Sanofi; Financial Interests, Personal, Advisory Board: Daiichi Pharma/AstraZeneca; Financial Interests, Personal, Advisory Board: Puma; Financial Interests, Personal, Advisory Board: Biotheranostics Inc.; Financial Interests, Personal, Advisory Board: Phillips; Financial Interests, Personal, Advisory Board: Eli Lilly; Financial Interests, Personal, Advisory Board: Foundation Medicine; Financial Interests, Institutional, Research Grant: Genentech; Financial Interests, Institutional, Research Grant: Novartis; Financial Interests, Institutional, Research Grant: Pfizer; Financial Interests, Institutional, Research Grant: Merck; Financial Interests, Institutional, Research Grant: Sanofi; Financial Interests, Institutional, Research Grant: Radius Health; Financial Interests, Institutional, Research Grant: Immunomedics; Financial Interests, Institutional, Research Grant: Daiichi Pharma/AstraZeneca; Non-Financial Interests, Personal, Research Grant, Medical writing support: F. Hoffmann-La Roche Ltd. V. Quiroga: Financial Interests, Personal, Other, Honoraria: F. Hoffmann-La Roche Ltd; Financial Interests, Personal, Other, Honoraria: Pfizer; Financial Interests, Institutional, Research Grant: Celgene; Financial Interests, Personal, Other, Travel/accommodation/ expenses: Novartis; Financial Interests, Institutional, Funding: Celgene; Non-Financial Interests, Personal, Research Grant, Medical writing support: F. Hoffmann-La Roche Ltd; Financial Interests, Personal, Other, Travel/accommodation/ expenses: F. Hoffmann-La Roche Ltd. V. López-Valverde: Financial Interests, Personal, Full or part-time Employment: F. Hoffmann-La Roche Ltd; Financial Interests, Personal, Stocks/Shares: F. Hoffmann-La Roche Ltd; Non-Financial Interests, Personal, Research Grant, Medical writing support: F. Hoffmann-La Roche Ltd. J. Steinseifer: Financial Interests, Personal, Full or part-time Employment: F. Hoffmann-La Roche Ltd; Financial Interests, Personal, Stocks/Shares: F. Hoffmann-La Roche Ltd; Non-Financial Interests, Personal, Research Grant, Medical writing support: F. Hoffmann-La Roche Ltd. H.M. Moore: Financial Interests, Personal, Full or part-time Employment: Genentech, Inc.; Financial Interests, Personal, Full or part-time Employment, Spouse: Pfizer Inc.; Financial Interests, Personal, Stocks/Shares: F. Hoffmann-La Roche Ltd; Non-Financial Interests, Personal, Research Grant, Medical writing support: F. Hoffmann-La Roche Ltd. G. Spera: Financial Interests, Personal, Full or part-time Employment, Senior Clinical Research Physician: Translational Research in Oncology; Non-Financial Interests, Personal, Research Grant, Medical writing support: F. Hoffmann-La Roche Ltd. C. Xue: Financial Interests, Personal, Full or part-time Employment: F. Hoffmann-La Roche Ltd; Non-Financial Interests, Personal, Research Grant, medical writing support: F. Hoffmann-La Roche Ltd. P.A. Fasching: Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Institutional, Research Grant: Biontech; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Advisory Board: Daiichi Sankyo; Financial Interests, Personal, Invited Speaker: Daiichi Sankyo; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Advisory Board: Eisai; Financial Interests, Personal, Invited Speaker: Eisai; Financial Interests, Personal, Advisory Board: Merck Sharp & Dohme; Financial Interests, Personal, Invited Speaker: Merck Sharp & Dohme; Financial Interests, Institutional, Research Grant: Cepheid; Financial Interests, Personal, Advisory Board: Lilly; Financial Interests, Personal, Invited Speaker: Lilly; Financial Interests, Personal, Advisory Board: Pierre Fabre; Financial Interests, Personal, Advisory Board: SeaGen; Financial Interests, Personal, Invited Speaker: SeaGen; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Advisory Board: Hexal; Financial Interests, Personal, Advisory Board: Agendia; Non-Financial Interests, Personal, Research Grant, Medical writing support: F. Hoffmann-La Roche Ltd.

Collapse
Mini Oral session

121MO - Acute toxicity associated with a 3-week versus a standard 5-week regimen for locoregional breast radiotherapy delivered in the UNICANCER HypoG-01 phase III trial

Presentation Number
121MO
Speakers
  • Sofia Rivera (Villejuif, France)
Lecture Time
18:03 - 18:08
Session Name
Location
Channel 1, Paris Expo Porte de Versailles, Paris, France
Date
Mon, 20.09.2021
Time
17:30 - 18:30

Abstract

Background

In most countries, the 5-week normofractionated (NF) locoregional radiotherapy (RT) is still the standard of care for breast cancer with an indication for regional lymph node irradiation. HypoG-01 (NCT03127995) is a randomized phase 3 clinical trial evaluating the safety and efficacy of a 3-week moderate hypofractionated (HF)-RT against NF-RT regimen. Here, we report for the first time the acute toxicity results, a secondary endpoint of the trial.

Methods

Women with pT1-3 pN0-3 M0 breast cancer were randomized 1:1 after surgery to receive either HF-RT: 40 Gy/15 fractions/3 weeks or NF-RT: 50 Gy/25 fractions/5 weeks. Acute toxicities were graded using CTCAE V4.0 at baseline, weekly during RT, and 1 month after the end of RT (end of treatment visit); the maximum grading is reported. Since arm lymphedema is the primary endpoint of the trial, it is not included in the acute toxicities of interest.

Results

From 09/2016 to 03/2020, 29 French sites enrolled 1265 women (HF-RT arm: 633, NF-RT arm: 632). All patients (median age: 58 years) received their allocated RT and completed their scheduled end of treatment visit. Acute grade 3 toxicities were rare in both treatment arms (HF-RT: 5.4%, NF-RT: 5.7%) and no grade 4-5 toxicities were observed (Table). The rate of overall grade 2 or higher acute toxicities was lower with HF-RT (38.4%) than with NF-RT (48.1%). Grade 2 or higher dermatitis were more frequent in patients with BMI ≥30 in both arms: 34/118 (29%) in HF-RT and 59/124 (48%) in NF-RT. In total 18 patients experienced at least 1 acute Serious Adverse Event (HF-RT: 10, NF-RT: 8) of which only 2 were considered treatment-related (HF-RT: 1, NF-RT: 1).

Acute adverse events of interest

HF-RT NF-RT TOTAL
G 1 n (%) G 2 n (%) G 3 n (%) HF Total n (%) G 1 n (%) G 2 n (%) G 3 n (%) NF Total n (%) n (%)
Dermatitis 418 (66) 82 (13) 9 (1) 509 (80) 365 (58) 183 (29) 13 (2) 561 (89) 1070 (85)
Fatigue 263 (42) 41 (6) 4 (1) 308 (49) 293 (46) 45 (7) 4 (1) 342 (54) 650 (51)
Pain 223 (35) 39 (6) 4 (1) 266 (42) 246 (39) 46 (7) 3 (0) 295 (47) 561 (44)
Dysphagia 109 (17) 16 (3) - 125 (20) 135 (21) 11 (2) - 146 (23) 271 (21)
Pruritus 112 (18) 10 (2) - 122 (19) 155 (25) 10 (2) 3 (0) 168 (27) 290 (23)
Dyspigmentation 74 (12) 4 (1) - 78 (12) 69 (11) 11 (2) 2 (0) 82 (13) 160 (13)
Respiratory disorders 88 (14) 11 (2) 1 (0) 100 (16) 125 (20) 11 (2) 2 (0) 138 (22) 238 (19)
Cardiac disorders 3 (0) 2 (0) 1 (0) 6 (1) 1 (0) - 1 (0) 2 (0) 8 (1)

Conclusions

In women receiving locoregional RT, acute toxicities with a 3-week moderately hypofractionated regimen were mild and raised no important acute safety concerns. Further long-term follow-up is ongoing.

Clinical trial identification

NCT03127995, Release date: 23/06/2016

Editorial acknowledgement

We thank Lilian AMREIN (R&D UNICANCER) for medical writing assistance of the abstract.

Legal entity responsible for the study

UNICANCER.

Funding

The French National Cancer Institute (PHRC-K).

Disclosure

S. Rivera: Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Invited Speaker: Eisai; Financial Interests, Personal, Invited Speaker: Lilly; Non-Financial Interests, Institutional, Leadership Role: The UNICANCER group of Translational research and development in RADiation oncology (UNITRAD). J. Clavier: Financial Interests, Personal, Stocks/Shares: Onco Outcome. S. Michiels: Financial Interests, Personal, Advisory Role: IDDI; Financial Interests, Personal, Advisory Role: Janssen Cilag; Financial Interests, Personal, Advisory Role: Amaris; Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Advisory Board: Hexal; Financial Interests, Personal, Advisory Board: IQVIA; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: Sensorion; Financial Interests, Personal, Advisory Board: Biophytis; Financial Interests, Personal, Advisory Board: Servier; Financial Interests, Personal, Advisory Board: Yuhan. All other authors have declared no conflicts of interest.

Collapse
Mini Oral session

122MO - Quality of life from the Penelope-B study on high-risk HR+/HER2- early breast cancer patients treated with endocrine therapy with or without palbociclib

Presentation Number
122MO
Speakers
  • José A. García-Saenz (Madrid, Spain)
Lecture Time
18:08 - 18:13
Session Name
Location
Channel 1, Paris Expo Porte de Versailles, Paris, France
Date
Mon, 20.09.2021
Time
17:30 - 18:30

Abstract

Background

The PENELOPE-B trial did not demonstrate improved invasive disease-free survival with the addition of one year of palbociclib to endocrine therapy (ET) compared to placebo plus ET in high risk HR+/HER2- early breast cancer patients with residual invasive breast cancer following neoadjuvant therapy. This analysis compared patient-reported outcomes (PROs) between the two treatment groups.

Methods

Patients were randomized 1:1 to receive palbociclib 125 mg/day (n=631) or placebo (n=619) orally for 3 weeks followed by 1 week off plus ET per standard of care. PROs were assessed during screening, on day 1 of cycles 1, 3, 5, 7, 9, 11, then, every 6 months after end of treatment visit using the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire (EORTC QLQ-C30) and its breast cancer (BR23) and fatigue (FA13) modules. Higher scores of C30 and FA13 (range 0-100) indicate better functioning and global health status/quality of life (GHS/QoL) or worse symptom severity, respectively. Repeated-measures mixed-effects models were used to evaluate differences in PRO between treatment groups, changes of PRO over time, and treatment-by-time interactions.

Results

Overall, 924 of 1250 patients (73.9%) completed the baseline and at least one post baseline questionnaire of all PRO instruments. GHS/QoL by the EORTC QLQ-C30 was generally high in both treatment arms (mean [SD]: palbociclib 70.1 [19.3], placebo 71.4 [18.8]) and was slightly higher in the placebo arm (LeastSquare mean difference: 0.82, p<0.001), especially during the active treatment phase of the study. Higher fatigue was reported in the palbociclib compared to placebo arm (mean [SD]: 30.3 [23.8] vs. 28.3 [22.7]; p<0.001). In contrast, no statistically significant differences were observed among the FA13 physical, cognitive, and emotional fatigue subscales.

Conclusions

In general, patient-reported QoL and fatigue was maintained during the study in both treatment arms. Statistically significant differences were observed between treatments in favor of the placebo arm; however, none were clinically relevant.

Clinical trial identification

NCT01864746

Legal entity responsible for the study

German Breast Group.

Funding

Pfizer Inc.

Disclosure

J.A. García-Saenz: Financial Interests, Personal, Funding: Lilly; Financial Interests, Personal, Funding: Pfizer; Financial Interests, Personal, Funding: Novartis; Financial Interests, Personal, Funding: Seagen; Financial Interests, Personal, Other: AstraZeneca; Financial Interests, Personal, Funding: Daiichi Sankyo; Financial Interests, Personal, Funding: MSD; Financial Interests, Other: Roche. F. Marmé: Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Personal, Other: AstraZeneca; Financial Interests, Personal, Other: MSD; Financial Interests, Personal, Other: Clovis; Financial Interests, Personal, Other: GSK/Tesaro; Financial Interests, Personal, Other: Pfizer; Financial Interests, Personal, Other: Novartis; Financial Interests, Personal, Other: Lilly; Financial Interests, Personal, Other: Roche; Financial Interests, Personal, Other: Celgene; Financial Interests, Personal, Other: Seagen; Financial Interests, Personal, Other: Myriad; Financial Interests, Personal, Other: PharmaMar; Financial Interests, Personal, Other: Eisai; Financial Interests, Personal, Other: Janssen-Cilag. H.S. Rugo: Financial Interests, Institutional, Research Grant: Pfizer; Financial Interests, Institutional, Research Grant: Merck; Financial Interests, Institutional, Research Grant: Novartis; Financial Interests, Institutional, Research Grant: Lilly; Financial Interests, Institutional, Research Grant: Genentech; Financial Interests, Institutional, Research Grant: Odonate; Financial Interests, Institutional, Research Grant: Daiichi; Financial Interests, Institutional, Research Grant: Seattle Genetics; Financial Interests, Institutional, Research Grant: Eisai; Financial Interests, Institutional, Research Grant: Macrogenics; Financial Interests, Institutional, Research Grant: Sermonix; Financial Interests, Institutional, Research Grant: Boehringer Ingelheim; Financial Interests, Institutional, Research Grant: Polyphor; Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Institutional, Research Grant: Immunomedics; Financial Interests, Personal, Advisory Role: Puma; Financial Interests, Personal, Advisory Role: Mylan; Financial Interests, Personal, Advisory Role: Samsung. M. Untch: Non-Financial Interests, Institutional, Funding, All fees to the institution/employer: AbbVie; Non-Financial Interests, Institutional, Funding, All fees to the institution/employer: Amgen GmbH; Non-Financial Interests, Institutional, Funding, All fees to the institution/employer: AstraZeneca; Non-Financial Interests, Institutional, Funding, All fees to the institution/employer: BMS; Non-Financial Interests, Institutional, Funding, All fees to the institution/employer: Celgene GmbH; Non-Financial Interests, Institutional, Funding, All fees to the institution/employer: Daiji Sankyo; Non-Financial Interests, Institutional, Funding, All fees to the institution/employer: Eisai GmbH; Non-Financial Interests, Institutional, Funding, All fees to the institution/employer: Lilly Deutschland; Non-Financial Interests, Institutional, Funding, All fees to the institution/employer: Lilly Int.; Non-Financial Interests, Institutional, Funding, All fees to the institution/employer: MSD Merck; Non-Financial Interests, Institutional, Funding, All fees to the institution/employer: Mundipharma; Non-Financial Interests, Institutional, Funding, All fees to the institution/employer: Myriad Genetics; Non-Financial Interests, Institutional, Funding, All fees to the institution/employer: Pfizer GmbH; Non-Financial Interests, Institutional, Funding, All fees to the institution/employer: Roche Pharma AG; Non-Financial Interests, Institutional, Funding, All fees to the institution/employer: Sanofi Aventis Deutschland GmbH; Non-Financial Interests, Institutional, Funding, All fees to the institution/employer: TEVA Pharmaceuticals Ind Ltd; Non-Financial Interests, Institutional, Funding, All fees to the institution/employer: Novartis; Financial Interests, Institutional, Funding, All fees to the institution/employer: Pierre Fabre; Non-Financial Interests, Institutional, Funding, All fees to the institution/employer: Clovis Oncology; Financial Interests, Institutional, Funding, All fees to the institution/employer: Seattle Genetics; Financial Interests, Institutional, Funding, All fees to the institution/employer: Seagen. S. Kim: Financial Interests, Institutional, Research Grant, institutional: Novartis; Financial Interests, Institutional, Research Grant, institutional: Sanofi-Aventis; Financial Interests, Institutional, Research Grant, institutional: DongKook Pharm Co; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: Lilly; Financial Interests, Personal, Advisory Board: Dae Hwa Pharmaceutical Co. Ltd; Financial Interests, Personal, Advisory Board: ISU Abxis; Financial Interests, Personal, Advisory Board: Daiichi-Sankyo; Financial Interests, Personal, Stocks/Shares: Genopeaks; Financial Interests, Personal, Stocks/Shares: NeogeneTC. H.D. Bear: Financial Interests, Personal, Research Grant: NSABP Foundation; Other, Personal, Stocks/Shares, Own stock in Pfizer: Pfizer. N. McCarthy: Financial Interests, Personal, Advisory Role: Pfizer; Financial Interests, Personal, Advisory Role: Novartis; Financial Interests, Personal, Advisory Role: AstraZeneca; Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Advisory Role: Specialised Therapeutics; Financial Interests, Personal, Advisory Role: Easai; Financial Interests, Personal, Advisory Role: Amgen; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: AstraZeneca; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Roche; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Novartis. K. Gelmon: Financial Interests, Personal, Funding: Pfizer; Financial Interests, Personal, Funding: Eli Lilly; Financial Interests, Personal, Funding: AstraZeneca; Financial Interests, Personal, Funding: Novartis; Financial Interests, Personal, Funding: Seagen; Financial Interests, Personal, Advisory Role: Pfizer; Financial Interests, Personal, Advisory Role: Eli Lilly; Financial Interests, Personal, Advisory Role: AstraZeneca; Financial Interests, Personal, Advisory Role: Novartis; Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Advisory Role: Seagen; Financial Interests, Personal, Advisory Role: Mylan; Financial Interests, Personal, Advisory Role: Merck; Financial Interests, Personal, Advisory Role: Nanostring; Financial Interests, Personal, Advisory Role: Genomic Health; Financial Interests, Institutional, Research Grant: Pfizer; Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Institutional, Research Grant: BMS; Financial Interests, Institutional, Research Grant: Roche; Financial Interests, Institutional, Research Grant: Seagen; Financial Interests, Personal, Expert Testimony: Genentech. M. Martin: Financial Interests, Personal, Research Grant: Roche; Financial Interests, Personal, Research Grant: Novartis; Financial Interests, Personal, Other: Daiichi Sankyo; Financial Interests, Personal, Funding: Lilly; Financial Interests, Personal, Research Grant: Puma; Financial Interests, Personal, Funding: AstraZeneca; Financial Interests, Personal, Funding: Pierre Fabre; Financial Interests, Personal, Funding: Pfizer. T. Reimer: Financial Interests, Personal, Funding: Pfizer. M. Toi: Financial Interests, Personal, Member of the Board of Directors: JBCRG association, Organisation for Oncology and Translational Research, Kyoto Breast Cancer Research Network; Financial Interests, Personal, Research Grant, Research grant, Lecture honoraria: Chugai; Financial Interests, Personal, Research Grant: Takeda; Financial Interests, Personal, Research Grant, Research grant, Lecture honoraria: Pfizer; Financial Interests, Personal, Research Grant, Research grant, Lecture honoraria, Advisory role for a drug development: Kyowa-Kirin; Financial Interests, Personal, Research Grant, Research grant, Lecture honoraria: Taiho; Financial Interests, Personal, Research Grant, Research grant: JBCRG association; Financial Interests, Personal, Research Grant, Research grant, Lecture honoraria: Eisai; Financial Interests, Personal, Research Grant, Research grant, Lecture honoraria, Advisory role for a drug development: Daiichi-Sankyo; Financial Interests, Personal, Research Grant, Research grant, Lecture honoraria: AstraZeneca; Financial Interests, Personal, Advisory Role, Lecture Honoraria, An advisory role: Eli Lilly; Financial Interests, Personal, Invited Speaker, Lecture Honoraria: MSD; Financial Interests, Personal, Invited Speaker, Lecture Honoraria: Exact Science; Financial Interests, Personal, Invited Speaker, Lecture Honoraria: Novartis; Financial Interests, Personal, Advisory Board, Honoraria for an advisory meeting: Konica Minolta; Financial Interests, Institutional, Research Grant, Research grant: Astellas; Financial Interests, Personal, Advisory Board, Honoraria for an advisory meeting: BMS; Financial Interests, Personal, Research Grant, Research grant, Lecture Honoraria: Shimadzu; Financial Interests, Personal, Research Grant, Research grant, Lecture Honoraria: Yakult; Financial Interests, Personal, Research Grant, Research Fund and Honoraria for lecture: Nippon Kayaku; Financial Interests, Institutional, Research Grant, Research grant: AFI technologies; Financial Interests, Personal, Advisory Role, An advisory role: Athenex Oncology; Financial Interests, Personal, Advisory Board, An advisory role: Bertis; Financial Interests, Personal, Advisory Board, An advisory role: Terumo; Financial Interests, Institutional, Research Grant, Research grant, an advisory role: Luxonus; Financial Interests, Institutional, Research Grant, Research grant: Shionogi; Financial Interests, Institutional, Research Grant, Research grant: GL Science; Financial Interests, Personal, Advisory Board, An advisory role: Kansai Medical Net. E.H. Law: Financial Interests, Personal, Full or part-time Employment: Pfizer Inc. M. Gnant: Financial Interests, Personal, Funding: Amgen; Financial Interests, Personal, Funding: Daiichi Sankyo; Financial Interests, Personal, Funding: AstraZeneca; Financial Interests, Personal, Funding: Eli Lilly; Financial Interests, Personal, Funding: LifeBrain; Financial Interests, Personal, Funding: Nanostring; Financial Interests, Personal, Funding: Novartis; Financial Interests, Personal, Funding: TLC Biopharmaceuticals; Other, Personal, Funding, an immediate family member is employed by Sandoz.: Sandoz. A. Makris: Financial Interests, Personal, Invited Speaker, Lectures for Pfizer: Pfizer; Financial Interests, Personal, Advisory Board, Advisory Boards with Pfizer: Pfizer. S. Loibl: Financial Interests, Institutional, Advisory Board, honorarium for Ad Boards & Lecture, paid to institute / Medical Writing: Pfizer; Financial Interests, Institutional, Advisory Board, honorarium for Ad Boards, paid to institute: AbbVie; Financial Interests, Institutional, Advisory Board, honorarium for Ad Boards, paid to institute: Amgen; Financial Interests, Institutional, Advisory Board, honorarium for Ad Boards & Lectures, paid to institute / Medical Writing: AstraZeneca; Financial Interests, Institutional, Advisory Board, honorarium for Ad Board, paid to institute: Bayer; Non-Financial Interests, Institutional, Advisory Board, honorarium for Ad Board, paid to institute / Medical Writing: BMS; Financial Interests, Institutional, Advisory Board, honorarium for Ad Board, paid to institute / Medical Writing: Celgene; Financial Interests, Personal, Invited Speaker, lecture: Chugai; Financial Interests, Institutional, Advisory Board, honorarium for Ad Board & Lecture, paid to institute / Medical Writing: Daiichi-Sankyo; Financial Interests, Institutional, Advisory Board, honorarium for Ad Board, paid to institute: Eirgenix; Financial Interests, Institutional, Advisory Board, honorarium for Ad Board, paid to institute: GSK; Financial Interests, Institutional, Research Grant, paid to institute: Immunomedics/Gilead; Financial Interests, Institutional, Other, paid to institute: Ipsen; Financial Interests, Institutional, Advisory Board, honorarium for Ad Boards, paid to institute: Lilly; Financial Interests, Institutional, Advisory Board, honorarium for Ad Board, paid to institute: Merck; Financial Interests, Institutional, Advisory Board, honorarium for Ad Board & Lectures, paid to institute / Medical Writing: Novartis; Financial Interests, Institutional, Advisory Board, honorarium for Ad Board & Lecture, paid to institute: Pierre Fabre; Financial Interests, Institutional, Advisory Board, honorarium for Ad Board & Lecture, paid to institute: Prime/Medscape; Financial Interests, Institutional, Advisory Board, honorarium for Ad Board, paid to institute: Puma; Financial Interests, Institutional, Advisory Board, honorarium for Ad Boards & Lectures, paid to institute / Medical Writing: Roche; Financial Interests, Institutional, Invited Speaker, honorarium for Lecture, paid to institute: Samsung; Financial Interests, Institutional, Advisory Board, honorarium for Ad Boards, paid to institute: Seagen; Financial Interests, Institutional, Writing Engagements, paid to institute / Medical Writing: Vifor; Financial Interests, Personal, Licensing Fees, Method for predicting the response to cancer immunotherapy in cancer patients: EP18209672.7; Financial Interests, Personal, Licensing Fees, Method for predicting the response to CDK4/6 inhibitor therapy in cancer patients: EP21152186.9; Financial Interests, Personal, Licensing Fees, Method for predicting the response to an anti-HER2 containing therapy and/or chemotherapy in patients with breast cancer: EP15702464.7; Financial Interests, Institutional, Licensing Fees, paid to institute: VM Scope GmbH,. All other authors have declared no conflicts of interest.

Collapse
Mini Oral session

123MO - BARBICAN: A randomized, phase II study to determine the contribution of ipatasertib to neoadjuvant chemotherapy plus atezolizumab in women with triple-negative breast cancer

Presentation Number
123MO
Speakers
  • Peter Schmid (London, United Kingdom)
Lecture Time
18:13 - 18:18
Session Name
Location
Channel 1, Paris Expo Porte de Versailles, Paris, France
Date
Mon, 20.09.2021
Time
17:30 - 18:30

Abstract

Background

Pathological complete response (pCR) to neoadjuvant treatment in TNBC is strongly correlated with improved EFS and OS. Randomised trials have demonstrated increased pCR rates with the addition of checkpoint inhibitors to NACT in TNBC. Preclinical evidence suggests that AKT inhibition can enhance checkpoint inhibitor efficacy. The AKT inhibitor ipatasertib (IPAT) has shown promising activity in combination with paclitaxel as 1L therapy for metastatic TNBC. BARBICAN was designed to evaluate the clinical and biological effects of adding IPAT to NACT plus atezolizumab (atezo).

Methods

International phase II, randomised trial in 146 patients (pts) with newly diagnosed, non-metastatic, high risk (node+ and/or tumour size ≥2 cm) TNBC. Patients were randomised (1:1) to receive one cycle of atezo (1200mg Q3W) ± IPAT (400mg D1-14), followed by 3 cycles of atezo (840mg Q2W) + weekly paclitaxel (80mg/m2) ± IPAT (400mg D1-21), followed by 4 cycles of atezo (840mg Q2W) + dose-dense doxorubicin (60mg/m2)/cyclophosphamide (600 mg/m2). Tumour biopsies were obtained at baseline, after each treatment phase and surgery. The primary clinical endpoint was pCR rate (ypT0/is ypN0). PD-L1 expression was assessed using the SP142 assay (1% cut-off).

Results

144 pts received treatment, IPAT (n = 72) vs no ipatasertib (no-IPAT) (n = 72). There was no difference in pCR rates between treatment groups (chemo/atezo + IPAT, 49.3%, 95%CI, 36.8%-61.8%; chemo/atezo alone, 48.5%, 95%CI, 36.2%-61.0%). For IPAT vs no-IPAT, pCR was 66.7% vs 75.0% in the PD-L1-positive population (65 pts) and 32.4% vs 25.0% in the PD-L1-negative population (70 pts). pCR in node-positive pts was 55.6% (IPAT, 51.6%, no-IPAT 59.4%) compared to 43.1% (IPAT, 47.2%, no-IPAT 38.9%) in node-negative pts. Grade 3 or higher AE rates were 73.6% in the chemo/atezo + IPAT group and 40.3% in the chemo/atezo alone group, with rash, neutropenia, ALT increase, diarrhoea and mucosits being the most common. The majority of patients required IPAT dose modifications and the dose intensity was low.

Conclusions

Addition of IPAT to neoadjuvant atezo plus chemotherapy did not improve pCR rates. IPAT dose intensity was low due to increased toxicity.

Clinical trial identification

NCT03800836.

Legal entity responsible for the study

Queen Mary University London.

Funding

F. Hoffmann-La Roche Ltd.

Disclosure

P. Schmid: Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: Bayer; Financial Interests, Personal, Advisory Board: Boehringer Ingelheim; Financial Interests, Personal, Advisory Board: Merck; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Advisory Board: Puma; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: Daiichi Sankyo; Financial Interests, Institutional, Research Grant: Astellas; Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Institutional, Research Grant: Genentech; Financial Interests, Institutional, Research Grant: Novartis; Financial Interests, Institutional, Research Grant: Oncogenex; Financial Interests, Institutional, Research Grant: Roche; Other, Other, Spouse - Employee: Roche. B. Bermejo: Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Invited Speaker: Lilly; Financial Interests, Personal, Advisory Board: Lilly; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Invited Speaker: Palex; Financial Interests, Personal, Invited Speaker: AstraZeneca; Other, Personal, Member of the Board of Directors: GEICAM . M. Phillips: Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Invited Speaker: Eisai; Financial Interests, Personal, Invited Speaker: Pfizer. D. Wheatley: Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: AZ; Financial Interests, Personal, Advisory Board: Daiichi; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: Pfizer. A. Llombart Cussac: Financial Interests, Stocks/Shares: MedSIR; Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Advisory Role: Eli Lilly; Financial Interests, Personal, Advisory Role: Novartis; Financial Interests, Personal, Advisory Role: EISAI; Financial Interests, Personal, Advisory Role: SEAGEN; Financial Interests, Personal, Advisory Role: Daiichi-Sanyo; Financial Interests, Personal, Advisory Role: Piere-Fabre; Financial Interests, Personal, Advisory Role: Agendia; Financial Interests, Research Grant: Roche; Financial Interests, Research Grant: Eli Lilly; Financial Interests, Research Grant: EISAI; Financial Interests, Research Grant: GSK; Financial Interests, Research Grant: Novartis; Financial Interests, Research Grant: Pfizer; Financial Interests, Research Grant: Agendia; Financial Interests, Research Grant: Genomic-Health; Financial Interests, Research Grant: AstraZeneca; Other, Other, Travel, accomodation, expenses: Roche; Other, Other, Travel, accomodation, expenses: Pfizer; Other, Other, Travel, accomodation, expenses: Eli Lilly. E. Zamora: Financial Interests, Personal, Training, Company internal training session: Novartis; Other, Personal, Other, Travel and accomodation to assist ESMO congresse: Pfizer; Other, Personal, Other, Travel and accomodation to assist ESMO congresse: Roche; Other, Personal, Other, Travel and accomodation to assist post-SABCS congresse: Lilly. G. Viale: Financial Interests, Personal, Other, Honoraria: MSD Oncology; Financial Interests, Personal, Other, Honoraria: Pfizer; Financial Interests, Personal, Other, Honoraria: Daiichi Sankyo Europe GmbH; Financial Interests, Personal, Advisory Board: Dako; Financial Interests, Personal, Advisory Board: Roche/Genentech; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: Bayer; Financial Interests, Personal, Advisory Board: Menarini; Financial Interests, Personal, Research Grant: Roche/Genentech; Financial Interests, Institutional, Research Grant: Ventana Medical Systems; Financial Interests, Institutional, Research Grant: Dako/Agilent; Financial Interests, Institutional, Research Grant: Cepheid; Other, Personal, Other, Travel: Roche; Financial Interests, Personal, Speaker’s Bureau: Roche/Genentech; Financial Interests, Personal, Advisory Board: Daiichi Sankyo; Financial Interests, Personal, Advisory Board: MSD Oncology. S. Kuemmel: Financial Interests, Personal, Advisory Role: Lilly; Financial Interests, Personal, Advisory Role: MSD; Financial Interests, Personal, Advisory Role: Somatex; Financial Interests, Personal, Speaker’s Bureau: Novartis; Financial Interests, Personal, Speaker’s Bureau: Roche; Financial Interests, Personal, Speaker’s Bureau: Genomic Health; Financial Interests, Personal, Speaker’s Bureau: Pfizer; Financial Interests, Personal, Speaker’s Bureau: Lilly; Financial Interests, Personal, Speaker’s Bureau: Amgen; Financial Interests, Personal, Speaker’s Bureau: MSD; Financial Interests, Personal, Speaker’s Bureau: PFM Medical; Financial Interests, Personal, Speaker’s Bureau: Celegene; Financial Interests, Personal, Speaker’s Bureau: AstraZeneca; Financial Interests, Personal, Speaker’s Bureau: Daiichi Sankyo; Financial Interests, Personal, Speaker’s Bureau: Somatex; Financial Interests, Personal, Speaker’s Bureau: Sonoscape; Financial Interests, Personal, Speaker’s Bureau: Seagen; Other, Other, Support for attending mettings and/or travel: Roche; Other, Other, Support for attending mettings and/or travel: Daiichi Sankyo; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: Genomic Health; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Advisory Board: Lilly; Financial Interests, Personal, Advisory Board: Amgen; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Advisory Board: PFM Medical; Financial Interests, Personal, Advisory Board: Celgene; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: Daiichi Sankyo; Financial Interests, Personal, Advisory Board: Somatex; Other, Personal, Leadership Role: WSG; Other, Personal, Leadership Role: AGO. J. Cortés: Financial Interests, Personal, Advisory Board: 4D Pharma PLC; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: Athenex; Financial Interests, Personal, Advisory Board: Bioasis; Financial Interests, Personal, Advisory Board: Biothera; Financial Interests, Personal, Advisory Board: Boehringer Ingelheim; Financial Interests, Personal, Advisory Board: Celgene; Financial Interests, Personal, Invited Speaker: Celgene; Financial Interests, Personal, Advisory Board: Cellestia; Financial Interests, Personal, Advisory Board: Clovis Oncology; Financial Interests, Personal, Advisory Board: Daiichi Sankyo; Financial Interests, Personal, Invited Speaker: Daiichi Sankyo; Financial Interests, Personal, Invited Speaker: Eisai; Financial Interests, Personal, Advisory Board: Erytech; Financial Interests, Personal, Advisory Board: GSK; Financial Interests, Personal, Advisory Board: Kyowa Kyrin; Financial Interests, Personal, Advisory Board: Leuko; Financial Interests, Personal, Advisory Board: Lilly; Financial Interests, Personal, Invited Speaker: Lilly; Financial Interests, Personal, Advisory Board: Merck Sharp & Dohme; Financial Interests, Personal, Invited Speaker: Merck Sharp & Dohme; Financial Interests, Personal, Advisory Board: Merus; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Advisory Board: Polyphor; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Invited Speaker: Samsung Bioepis; Financial Interests, Personal, Advisory Board: Seattle Genetics; Financial Interests, Personal, Advisory Board: Servier; Financial Interests, Personal, Stocks/Shares: MedSIR; Financial Interests, Institutional, Research Grant: Ariad Pharmaceuticals; Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Institutional, Research Grant: Baxalta GMBH/Servier Affaires; Financial Interests, Institutional, Research Grant: Bayer Healthcare; Financial Interests, Institutional, Research Grant: Eisai; Financial Interests, Institutional, Research Grant: Guardanth Health; Financial Interests, Institutional, Research Grant: Merck Sharp & Dohme; Financial Interests, Institutional, Research Grant: Pfizer; Financial Interests, Institutional, Research Grant: Piqur Therapeutics; Financial Interests, Institutional, Research Grant: Puma B; Financial Interests, Institutional, Research Grant: Queen Mary University of London; Financial Interests, Institutional, Research Grant: Roche; Other, Personal, Other, Travel cost and expenses: Daiichi Sankyo; Other, Personal, Other, Travel cost and expenses: Eisai; Other, Personal, Other, Travel cost and expenses: Novartis; Other, Personal, Other, Travel cost and expenses: Roche. All other authors have declared no conflicts of interest.

Collapse
Mini Oral session

Discussion LBA14, 121MO, 122MO and 123MO

Speakers
  • Véronique Diéras (Rennes, CEDEX, France)
Lecture Time
18:18 - 18:28
Session Name
Location
Channel 1, Paris Expo Porte de Versailles, Paris, France
Date
Mon, 20.09.2021
Time
17:30 - 18:30