Background

Recent studies have demonstrated a benefit of adjuvant capecitabine, particularly in triple negative breast cancer (TNBC) patients with residual disease after neoadjuvant chemotherapy. However, biomarkers to predict which patients are more likely to benefit from capecitabine are needed.

Methods

The NanoString Breast Cancer 360^TM (BC360) and PanCancer Immunoncology^TM (IO360) panels were used to quantify mRNA expression in TNBC samples in the FinXX trial. FinXX is a phase III trial which randomized high risk patients to receive either 3 cycles of docetaxel followed by 3 cycles of cyclophosphamide, epirubicin, and fluorouracil (Arm A: T+CEF) vs. 3 cycles of docetaxel plus capecitabine followed by 3 cycles of cyclophosphamide, epirubicin, and capecitabine (Arm B: TX+CEX). Gene signature scores were analyzed using prespecified algorithms developed by NanoString. Digital Spatial Profiling was carried out using GeoMX™ platform. A total of 111 TNBC patients were included (57 in Arm A and 54 in Arm B) with 10.2 years median follow up.

Results

There were 7 cancer- and immune-related gene signatures identified by BC360 and IO360 panels that were significantly associated with improved recurrent free survival favoring an addition of capecitabine. These include cytotoxic cell signature, endothelial signature, mast cell signature, PDL2 gene, immunoproteasome, exhausted CD8 T-cells, and PD1. Spatially-defined analysis of protein expression of a subset of the tumor specimens using the GeoMx platform revealed biological compartment specific (Tumor and/or Stroma) differential expression of immune-related proteins in patients with improved recurrent free survival.

Conclusions

Analysis of RNA abundance signatures strongly suggests that there are important immune features that are associated with benefit from capecitabine in TNBC. However, analysis of RNA extracted from whole tumor sections lacks spatial discrimination. Using the GeoMx platform for the spatially-defined analysis of protein abundance has provided more insights and has defined specific immune features associated with improved outcome.

Clinical trial identification

NCT00114816.

Legal entity responsible for the study

The authors.

Funding

Finnish Breast Cancer Group.

Disclosure

D.A. Hinerfeld: Full / Part-time employment: Nanostring. H.A. Brauer: Full / Part-time employment: Nanostring. T. Nielsen: Licensing / Royalties: Nanostring. All other authors have declared no conflicts of interest.

Background

HLX02, a fully-humanised anti-HER2 monoclonal antibody, was developed as trastuzumab (TZB) biosimilar to potentially increase treatment accessibility. The clinical program was developed in consultation with China National Medical Products Administration (NMPA) and European Medicines Agency (EMA) for global development. Previously, we reported clinical PK equivalence of HLX02 and TZBs at the ESMO-ASIA 2018 meeting. Here, we report the phase III study results.

Methods

We conducted a randomised, double-blind, parallel-controlled phase III study of HLX02 and EU-TZB at 89 centres in China, Philippines, Poland and Ukraine. Eligible adult women with HER2+ breast cancer were randomised to 8 mg/kg of either HLX02 or EUTZB with docetaxel on Day 1 Cycle 1 followed by a dose of 6 mg/kg in 3weekly cycles for up to 12 months. Primary endpoint was best overall response rate at Week 24 (ORR_wk24). Secondary endpoints included ORR at weeks 6, 12, 18 and 24, clinical benefit rate (CBR), disease control rate (DCR), duration of response (DoR), progression-free survival (PFS), overall survival (OS), and safety profiles up to 12 months.

Results

Of the 649 patients being randomised (HLX02=324; EUTZB=325), the ORR_wk24 (HLX02=71.0%; EU-TZB =71.4%; p = 0.952) and risk difference in ORRs (-0.4%; 95% CI: -7.4, 6.6) between the two groups were within the pre-defined margin (±13.5%). All secondary efficacy analyses at Week 24 concluded the therapeutic equivalence. Both groups in all populations (overall, Asian vs. non-Asian, and Chinese vs. non-Chinese) had similar range values of CBR (HLX02: 78.6% - 86.8%; EU-TZB: 79.3% - 82.4%) and DCR (HLX02: 80.6% - 95.4%; EU-TZB: 86.9% - 89.2%). 641 (98.8%) reported at least 1 AE (HLX02 and EU-TZB were 98.8%). Similar incidences of AEs (HLX02: 6610; EU-TZB: 6788), TEAEs (HLX02: 6464; EU-TZB: 6638) and immunogenicity were reported at Week 24.

Conclusions

The use of HLX02 compared with EUTZB resulted in an equivalent ORR at Week 24. All secondary efficacy and safety analyses of HLX02 at Week 24 supported the conclusion of biosimilarity without clinical meaningful differences with EUTZB. This interim analysis has been submitted to NMPA and EMA to support marketing approval of HLX02 in China and Europe.

Clinical trial identification

NCT03084237; EudraCT: 2016-000206-10; Chinese Clinical Trial Register: 2015L01326.

Legal entity responsible for the study

Shanghai Henlius Biotech, Inc.

Funding

Shanghai Henlius Biotech, Inc.

Disclosure

T. Sun: Research grant / Funding (institution): Shanghai Henlius Biotech, Inc. W. Li: Research grant / Funding (institution): Shanghai Henlius Biotech, Inc. Y. Teng: Research grant / Funding (institution): Shanghai Henlius Biotech, Inc. I. Bondarenko: Research grant / Funding (institution): Shanghai Henlius Biotech, Inc. H. Adamchuk: Research grant / Funding (institution): Shanghai Henlius Biotech, Inc. Y. Li: Full / Part-time employment: Shanghai Henlius Biotech, Inc. B. Shan: Full / Part-time employment: Shanghai Henlius Biotech, Inc. J. Cheng: Full / Part-time employment: Shanghai Henlius Biotech, Inc. T. Peng: Full / Part-time employment: Shanghai Henlius Biotech, Inc. X. Wang: Full / Part-time employment: Shanghai Henlius Biotech, Inc. Y. Chen: Full / Part-time employment: Shanghai Henlius Biotech, Inc. W. Jiang: Full / Part-time employment: Shanghai Henlius Biotech, Inc. S. Liu: Full / Part-time employment: Shanghai Henlius Biotech, Inc. X. Zhang: Full / Part-time employment: Shanghai Henlius Biotech, Inc. E. Liu: Full / Part-time employment: Shanghai Henlius Biotech, Inc. A. LUK: Full / Part-time employment: Shanghai Henlius Biotech, Inc. Q. Wang: Full / Part-time employment: Shanghai Henlius Biotech, Inc.

Background

Pts with HER2+ early BC and residual invasive disease after neoadjuvant chemotherapy plus HER2-targeted therapy have a higher risk of recurrence and death than those with a pCR. The KATHERINE (NCT01772472) study showed significantly improved invasive disease-free survival (IDFS) with adjuvant T-DM1 vs H in this population. Here, we compare Chinese pts in KATHERINE to the overall population.

Methods

Pts with HER2+ BC and residual invasive disease after taxane- and H-containing neoadjuvant chemotherapy followed by surgery were randomized 1:1 to 14 cycles of adjuvant T-DM1 (3.6 mg/kg IV q3w) or H (6 mg/kg IV q3w). IDFS and the secondary endpoints of disease-free survival including non-invasive breast cancers, overall survival, distant recurrence-free interval, and safety were compared between Chinese pts (mainland China, Taiwan, Hong Kong) and the overall population.

Results

There were 101 (6.8%) Chinese pts in KATHERINE. IDFS was greater in the T-DM1 vs the H group (HR = 0.57; 95% CI: 0.25–1.31), with similar results for secondary endpoints (Table). As in the overall population, Chinese pts receiving T-DM1 vs H had more grade ≥3 adverse events (AEs; 39% vs 4%), serious AEs (SAEs; 20% vs 2%); and AEs leading to treatment discontinuation (28% vs 0). The most common grade ≥3 AE in the T-DM1 arm was thrombocytopenia (22%), a frequency higher than in the overall population (6%). Grade ≥3 hemorrhage was reported in 1 pt (T-DM1 arm). All grade ≥3 thrombocytopenia was resolved or resolving at data cutoff.Table: 1O

Conclusions

Consistent with the overall study population, T-DM1 was associated with increased efficacy compared to H in Chinese pts. Compared to all pts, increases in SAEs, grade ≥3 AEs, and AEs leading to discontinuation were observed in Chinese pts and were driven by an increase in thrombocytopenia, consistent with previous data in Asian pts.

Clinical trial identification

NCT01772472.

Editorial acknowledgement

Medical writing assistance was provided by Twist Medical and was funded by F. Hoffmann–La Roche.

Legal entity responsible for the study

F. Hoffmann-La Roche.

Funding

F. Hoffmann-La Roche.

Disclosure

C. Huang: Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Amgen; Advisory / Consultancy, Research grant / Funding (institution): Eli Lilly; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: Pfizer; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: Roche; Speaker Bureau / Expert testimony, Research grant / Funding (institution): Novartis; Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): EirGenix; Research grant / Funding (institution): MSD; Research grant / Funding (institution): OBI Pharma. Y. Yang: Research grant / Funding (institution): Roche; Research grant / Funding (institution): Novartis; Research grant / Funding (institution): Eli Lilly; Research grant / Funding (institution): Ono; Research grant / Funding (institution): Astellas; Research grant / Funding (institution): Celgene; Research grant / Funding (institution): Janssen; Research grant / Funding (institution): Mundipharma; Research grant / Funding (institution): Orient Europharma; Full / Part-time employment: Taichung Veterans General Hospital. A. Kwong: Honoraria (self), ICG Fluorescence in Breast Surgery speaker: Stryker; Honoraria (self), Chairing Meeting: AstraZeneca; Honoraria (self), Chairing Meeting: Pfizer; Honoraria (self), Honoraria (institution), Chairing Meeting, Support on trial to HKU: Roche; Honoraria (institution), Suppprt on trial to HKU: Merck; Honoraria (institution), Support on trial to HKU: Novartis; Honoraria (institution), Supporting device & consumables for Prospective Study on Cryosurgery for treatment of Early Breast Cancer.: WKK Medical Equipment company limited; Leadership role, Chairman: Hong Kong Hereditary Breast Cancer Family Registry; Leadership role, Founding member: Asian BRCA (ABRCA); Leadership role, Council Member: Hong Kong Society of Breast Surgeons. L-M. Tseng: Advisory / Consultancy, Travel / Accommodation / Expenses: Amgen; Advisory / Consultancy: Eli Lilly; Advisory / Consultancy, Research grant / Funding (institution): Novartis; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: Roche; Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: Pfizer; Travel / Accommodation / Expenses: AstraZeneca. M-C. Liu: Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Roche. Y. Feng: Full / Part-time employment: Roche (China) Holding Ltd. G. Sun: Full / Part-time employment: Roche (China) Holding Ltd. I.R. Yan: Full / Part-time employment: Roche (China) Holding Ltd. All other authors have declared no conflicts of interest.

Background

The global ph III IMpassion130 study (NCT02425891) in 1L mTNBC showed that PFS with atezolizumab (A) + nab-P (A+nab-P) was significantly better than with placebo (P) + nab-P in ITT and PD-L1 IC+ pts; clinically meaningful OS improvement was also seen in PD-L1 IC+ pts (Schmid et al. NEJM 2018, ASCO 2019). As region-specific differences have been reported for efficacy and toxicity of other therapies, we report outcomes for A+nab-P in IMpassion130 pts enrolled in Hong Kong, Japan, Singapore, South Korea, Taiwan, Thailand.

Methods

Eligible pts with histologically documented advanced TNBC, ECOG PS 0-1 and tumour tissue for PD-L1 testing were randomised 1:1 to IV atezolizumab 840 mg or placebo on d1 and 15 (q2w) + nab-P 100 mg/m² on d1, 8 and 15 of a 28-d cycle until progression. Stratification factors were prior taxanes, liver mets and PD-L1 expression on tumour-infiltrating immune cells (IC, positive: ≥1%). Co-primary endpoints (EPs) were PFS (ITT and PD-L1+ pts) and OS (ITT and, if significant, PD-L1+ pts). Key secondary EPs were ORR and DOR.

Results

As of 2 Jan 2019, median follow-up was 20.0 mo in 145 pts in Asian countries. In the A+nab-P (n = 79) and P+nab-P (n = 66) arms, respectively, 42% and 33% had prior (neo)adjuvant taxane treatment (tx), 29% and 17% had liver mets, and 43% and 35% were PD-L1 IC+. Efficacy data are in the table. As of 3 Sep 2018, all-cause, any-grade AEs occurred in 100% (G3-4, 44% and 39%) of safety-evaluable pts in the A+nab-P and P+nabP arms (n = 78, 65), respectively. Serious tx-related AEs occurred in 8% of A+nab-P and 6% of P+nab-P pts. G3-4 AEs of special interest occurred in 5% of A+nab-P and P+nab-P pts.

Conclusions

In this post-hoc analysis, the efficacy of A+nab-P in IMpassion130 pts in Asian countries was consistent with the previously reported global ITT and PD-L1 IC+ pts. No new safety signals were observed, and tolerability was consistent with that of the overall population.Table: 37O

Efficacy results in pts in Asian countries

Clinical trial identification

NCT02425891.

Editorial acknowledgement

Medical writing assistance for this abstract was provided by Jonathan Lee, PhD, of Health Interactions, Ltd. and 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

H. Iwata: Honoraria (self), Advisory / Consultancy: Chugai/Roche; Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self), Advisory / Consultancy: AstraZeneca; Honoraria (self), Advisory / Consultancy: Pfizer; Honoraria (self), Advisory / Consultancy: Lilly; Honoraria (self), Advisory / Consultancy: Daiichi-Sankyo. S-A. Im: Advisory / Consultancy, Research grant / Funding (institution): AstraZeneca; Advisory / Consultancy: Amgen; Advisory / Consultancy: Eisai; Advisory / Consultancy: Hanmi; Advisory / Consultancy: Ildong; Advisory / Consultancy: MediPactor; Advisory / Consultancy: Novartis; Advisory / Consultancy: Roche; Speaker Bureau / Expert testimony, Research grant / Funding (institution): Pfizer. J. Sohn: Research grant / Funding (self): MSD; Research grant / Funding (self): Roche; Research grant / Funding (self): Novartis; Research grant / Funding (self): AstraZeneca; Research grant / Funding (self): Lilly; Research grant / Funding (self): Pfizer; Research grant / Funding (self): Bayer; Research grant / Funding (self): GSK; Research grant / Funding (self): CONTESSA; Research grant / Funding (self): Daiichi Sankyo. K.H. Jung: Honoraria (self), Advisory / Consultancy: Roche; Honoraria (self), Advisory / Consultancy: AstraZeneca. K.S. Lee: Research grant / Funding (institution), Drug Supply: Dong-A Socio ; Advisory / Consultancy: Roche; Advisory / Consultancy: Novartis; Advisory / Consultancy: Lilly; Advisory / Consultancy: Pfizer. K. Inoue: Research grant / Funding (institution): Novartis; Honoraria (self), Research grant / Funding (institution): Pfizer; Honoraria (self), Research grant / Funding (institution): Chugai; Research grant / Funding (institution): Daiichi-Sankyo; Research grant / Funding (institution): Parexel/Puma Biotechnology; Research grant / Funding (institution): MSD; Research grant / Funding (institution): Bayer; Research grant / Funding (institution): Eli Lilly; Honoraria (self), Research grant / Funding (institution): Eisai. K. Tamura: Research grant / Funding (institution): Chugai. A. Wong: Research grant / Funding (institution): National Medical Research Council, Singapore; Research grant / Funding (institution): Otsuka Pharmaceuticals; Advisory / Consultancy: Novartis; Advisory / Consultancy: Pfizer; Travel / Accommodation / Expenses: Eisai. L.A. Emens: Honoraria (self): AbbVie; Honoraria (self): Amgen; Honoraria (self), Research grant / Funding (institution), Travel / Accommodation / Expenses: AstraZeneca; Honoraria (self), Travel / Accommodation / Expenses: Bayer; Research grant / Funding (institution), Travel / Accommodation / Expenses: Bristol-Myers Squibb; Honoraria (self): Celgene; Research grant / Funding (institution), Travel / Accommodation / Expenses: Genentech/Roche; Honoraria (self): Gritstone; Honoraria (self): Medimmune; Honoraria (institution), Travel / Accommodation / Expenses: Macrogenics; Travel / Accommodation / Expenses: Novartis; Honoraria (self): Peregrine; Honoraria (self), Travel / Accommodation / Expenses: Replimune; Honoraria (self): Syndax; Honoraria (self), Travel / Accommodation / Expenses: Vaccinex; Research grant / Funding (institution), Licensing / Royalties: Aduro Biotech; Research grant / Funding (institution): Breast Cancer Research Foundation; Research grant / Funding (institution): Corvus; Research grant / Funding (institution): Department of Defense; Research grant / Funding (institution): EMD Serono; Research grant / Funding (institution): HeritX, Inc.; Research grant / Funding (institution): Maxcyte; Research grant / Funding (institution): Merck; Research grant / Funding (institution): National Cancer Institute; Research grant / Funding (institution): NSABP Foundation; Research grant / Funding (institution): Translational Breast Cancer Research Consortium. C.H. Barrios: Advisory / Consultancy, Research grant / Funding (institution): Roche/Genentech; Advisory / Consultancy, Research grant / Funding (institution): Pfizer; Advisory / Consultancy, Research grant / Funding (institution): Novartis; Research grant / Funding (institution): Amgen; Advisory / Consultancy, Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): Boehringer Ingelheim; Advisory / Consultancy, Research grant / Funding (institution): GlaxoSmithKline; Research grant / Funding (institution): Roche/Genentech; Research grant / Funding (institution): Lilly; Research grant / Funding (institution): Sanofi; Research grant / Funding (institution): Taiho Pharmaceutical; Research grant / Funding (institution): Mylan; Research grant / Funding (institution): Merrimack; Research grant / Funding (institution): Merck; Research grant / Funding (institution): AbbVie; Research grant / Funding (institution): Astellas Pharma; Research grant / Funding (institution): Biomarin; Research grant / Funding (institution): Bristol-Myers Squibb; Research grant / Funding (institution): Daiichi Sankyo; Research grant / Funding (institution): Abraxis; Research grant / Funding (institution): AB Science; Research grant / Funding (institution): Asana Biosciences; Research grant / Funding (institution): Medivation; Research grant / Funding (institution): Exelixis; Research grant / Funding (institution): ImClone Systems; Research grant / Funding (institution): LEO Pharma; Research grant / Funding (institution): Millennium; Advisory / Consultancy: Boehringer Ingelheim; Advisory / Consultancy: Eisai; Advisory / Consultancy: Bayer; Advisory / Consultancy: MSD. S. Adams: Research grant / Funding (institution): Genentech; Research grant / Funding (institution): Merck; Research grant / Funding (institution): Amgen; Research grant / Funding (institution): BMS; Research grant / Funding (institution): Novartis; Research grant / Funding (institution): Celgene. A. Schneeweiss: Honoraria (self), Research grant / Funding (institution), Travel / Accommodation / Expenses: Celgene; Honoraria (self), Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: Roche; Research grant / Funding (institution): AbbVie; Research grant / Funding (institution): Molecular Partner; Honoraria (self), Speaker Bureau / Expert testimony: AstraZeneca; Honoraria (self), Travel / Accommodation / Expenses: Pfizer; Honoraria (self): MSD; Honoraria (self): Tesaro; Honoraria (self): Lilly; Honoraria (self): Novartis. V. Diéras: Advisory / Consultancy: Roche/Genentech; Advisory / Consultancy: Pfizer; Advisory / Consultancy: Lilly; Advisory / Consultancy: Novartis; Advisory / Consultancy: Daiichi Sankyo; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: AbbVie; Advisory / Consultancy: Seattle Genetics; Advisory / Consultancy: Odonate. E.P. Winer: Honoraria (self): Lilly; Honoraria (self), SAB member and honoraria: LEAP; Honoraria (self): Genentech; Honoraria (self): Inifinite MD; Honoraria (self): Carrick Therapeutics; Honoraria (self): GSK; Honoraria (self): Jounce; Honoraria (self): Genomic Health; Honoraria (self): Merck; Honoraria (self): Seattle Genetics. S.Y. Chui: Full / Part-time employment: Roche/Genentech. V. Henschel: Shareholder / Stockholder / Stock options, Full / Part-time employment: Roche. H.S. Rugo: Research grant / Funding (institution): Pfizer; Research grant / Funding (self): Novartis; Research grant / Funding (institution): Lilly; Research grant / Funding (institution), Travel / Accommodation / Expenses: Genentech/Roche; Research grant / Funding (institution), Travel / Accommodation / Expenses: Macrogenics; Travel / Accommodation / Expenses: PUMA; Travel / Accommodation / Expenses: Mylan; Research grant / Funding (institution): Merck; Research grant / Funding (institution): OBI; Research grant / Funding (institution): Eisai; Research grant / Funding (institution): Plexxikon; Research grant / Funding (self), Travel / Accommodation / Expenses: Daiichi; Research grant / Funding (self): Immunomedics; Honoraria (self): Celltrion. S. Loi: Advisory / Consultancy, Research grant / Funding (institution), non-remunerated consultant: Novartis; Advisory / Consultancy, Research grant / Funding (institution), non-remunerated consultant: Bristol-Myers Squibb; Advisory / Consultancy, Research grant / Funding (institution), non-remunerated consultant: Roche/Genentech; Research grant / Funding (institution): PUMA Biotech; Research grant / Funding (institution): Eli Lilly; Advisory / Consultancy, Research grant / Funding (institution), non-remunerated consultant: Merck; Advisory / Consultancy, non-remunerated consultant: Seattle Genetics; Advisory / Consultancy, non-remunerated consultant: Pfizer; Advisory / Consultancy, Consulting fees paid to institution: Aduro Biotech. P. Schmid: Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): Roche/Genetech; Research grant / Funding (institution): Oncogenex; Research grant / Funding (institution): Novartis; Research grant / Funding (institution): Astellas; Honoraria (self): Pfizer; Honoraria (self): Merck; Honoraria (self): Boehringer Ingelheim; Honoraria (self): Bayer; Honoraria (self): Eisai; Honoraria (self): Celgene; Honoraria (self): PUMA Biotech. All other authors have declared no conflicts of interest.

Background

The oral PARP inhibitor TALA is approved in multiple countries (US/EU/ARG/UAE) for HER2- gBRCA1/2mut ABC. To date, limited information is available on use of TALA in Asian pts.

Methods

EMBRACA (NCT01945775) is an ongoing randomized study comparing TALA 1 mg/day vs PCT in HER2- gBRCA1/2mut ABC. Primary endpoint: progression-free survival (PFS) by blinded review; secondary endpoints: PFS by investigator; objective response rate (ORR); safety (adverse events [AEs]). Endpoints were assessed in Asian pts (APAC; Korea, Taiwan) and in the intent-to-treat (ITT) population.

Results

431 pts were randomized (TALA: ITT 287, APAC 23; PCT: ITT 144, APAC 10). In APAC pts, median age was 41.0 and 45.0 y in TALA and PCT, with 73.9% and 60.0% aged <50 y, respectively; ITT median age was 45.0 and 50.0 y, with 63.4% and 46.5% aged <50 y, respectively. In APAC pts, triple-negative (42.4%) and hormone-receptor–positive (57.6%) disease were consistent with ITT pts. TALA was more effective than PCT in APAC pts, similar to ITT pts (Table). In APAC pts receiving TALA, most common (≥10%) hematologic AEs were neutropenia (34.8%), anemia (17.4%), platelet count decrease (13.0%), thrombocytopenia (13.0%), and neutrophil count decrease (8.7%); common (≥30%) non-hematologic AEs were nausea (47.8%), fatigue (43.5%), URTI (30.4%), and decreased appetite (30.4%). AEs were generally consistent with ITT. Median relative dose intensity (actual-dose intensity/planned-dose intensity) for TALA was 99.7% APAC and 87.2% ITT. No APAC pts permanently discontinued due to AEs in either arm; 5.9% (TALA) and 8.7% (PCT) permanently discontinued due to AEs in ITT.

Conclusions

In pts with HER2- gBRCA1/2mut ABC, TALA improved outcomes vs PCT. Results in a limited number of enrolled Asian pts were generally consistent with the ITT population.Table: 38O

Clinical trial identification

NCT01945775.

Editorial acknowledgement

Editorial support, under the direction of the authors, was provided by Ann Gordon, PhD, of CMC AFFINITY, a division of McCann Health Medical Communications Ltd., Glasgow, UK, funded by Pfizer Inc.

Legal entity responsible for the study

Pfizer.

Funding

Pfizer (Medivation).

Disclosure

K-H. Lee: Honoraria (institution), Advisory / Consultancy: Roche; Honoraria (institution), Advisory / Consultancy: AstraZenceca; Advisory / Consultancy: Bayer; Advisory / Consultancy: Ono pharmaceutical; Advisory / Consultancy: Samsung bioepis; Advisory / Consultancy: Eisai. S-B. Kim: Research grant / Funding (institution): Novartis. J. Sohn: Research grant / Funding (institution): MSD; Research grant / Funding (institution): Roche; Research grant / Funding (institution): Novartis; Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): Lilly; Research grant / Funding (institution): Pfizer; Research grant / Funding (institution): Bayer; Research grant / Funding (institution): GSK; Research grant / Funding (institution): CONTESSA; Research grant / Funding (institution): Daiichi Sankyo. A. Goodwin: Travel / Accommodation / Expenses: Pfizer; Travel / Accommodation / Expenses: AstraZeneca; Travel / Accommodation / Expenses: Roche; Travel / Accommodation / Expenses: Novartis; Travel / Accommodation / Expenses: Amgen; Travel / Accommodation / Expenses: Celgene; Travel / Accommodation / Expenses: Boehringher. T. Usari: Shareholder / Stockholder / Stock options, Full / Part-time employment: Pfizer Inc. S. Lanzalone: Shareholder / Stockholder / Stock options, Full / Part-time employment: Pfizer Inc. All other authors have declared no conflicts of interest.