All times are listed in CEST (Central European Summer Time)
- Andres Cervantes (Valencia, Valencia, Spain)
- Pasi A. Jänne (Boston, MA, United States of America)
LBA4_PR - Abiraterone acetate plus prednisolone (AAP) with or without enzalutamide (ENZ) added to androgen deprivation therapy (ADT) compared to ADT alone for men with high-risk non-metastatic (M0) prostate cancer (PCa): Combined analysis from two comparisons in the STAMPEDE platform protocol
- Gerhardt Attard (London, United Kingdom)
Abstract
Background
Patients (pts) with high-risk M0 PCa are treated with ADT and when indicated, local radiotherapy (RT). Intensifying hormone treatment with AAP, ENZ or apalutamide continuous to progression improves outcomes of metastatic PCa but its efficacy in M0 PCa starting ADT is unknown.
Methods
STAMPEDE is a multi-arm, multi-stage trial that, as part of 2 separate comparisons randomised PCa pts with M0 node positive or high-risk node negative (>1 T3/4, PSA ≥40ng/ml, Gleason 8-10 or relapsing) 1:1 to ADT (control) vs ADT with AAP (1000mg AA + 5mg P od) or ADT vs ADT with AAP + ENZ (160mg od) for 2 years (y), unless RT was omitted when treatment could be to progression. The primary end-point was metastasis-free survival (MFS, time to death or distant metastases). The sub-group of pts who received ADT +/- AAP was partially reported with metastatic pts in 2017 so one-sided type 1 error rate was set to 1.25%. All analyses were pre-specified, pooled using meta-analyses methods and stratified as described previously. Data frozen 3rd August 2021.
Results
1974 M0 pts at 113 sites in UK & Switzerland were randomised, 914 (Nov 2011 to Jan 2014) to ADT +/- AAP & 1060 (Mar 2016 to Jul 2014) to ADT +/- AAP + ENZ. Groups were well balanced: median age 68 y, range 43-86; median PSA 34 ng/ml, range 0.4-2773; Gleason 8-10, 79%; node positive 39%; planned for RT 85%. Median months to stopping AAP, 23.7 (IQR: 17.6-24.1); AAP when given with ENZ, 20.7 (IQR: 4.4-24); ENZ, 23.2 (IQR: 6.3-24). 180 MFS events occurred in the research group and 306 in the control group. AAP-based therapy improved MFS (HR 0.53, 95% CI 0.44-0.64, P=2.9×10- 11) & survival (HR 0.60, 95% CI 0.48-0.73, P=9.3×10-7): 6-y MFS from 69% to 82%, 6-y survival from 77% to 86%. Treatment effect was consistent in major subgroups and between AAP & AAP + ENZ randomisation periods (MFS HR=0.54, 95% CI 0.43-0.68; HR=0.53, 95% CI 0.39-0.71 respectively; interaction HR = 1.02, 95% CI: 0.70-1.50, p=0.908).
Conclusions
2 y of AAP-based therapy significantly improves MFS & survival of high-risk M0 PCa starting ADT and should be considered a new standard of care.
Clinical trial identification
NCT00268476.
Legal entity responsible for the study
Medical Research Council Clinical Trials Unit at University College London.
Funding
Cancer Research UK, Medical Research Council, Astellas, Janssen.
Disclosure
G. Attard: Financial Interests, Personal, Invited Speaker: Janssen; Financial Interests, Personal, Advisory Board: Janssen; Financial Interests, Personal, Invited Speaker: Astellas; Financial Interests, Personal, Advisory Board: Astellas; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: Bayer; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Advisory Board: Sanofi; Financial Interests, Personal, Advisory Board: Sapience; Financial Interests, Personal, Advisory Board: Orion; Financial Interests, Personal, Royalties: Janssen; Financial Interests, Institutional, Research Grant: Janssen; Financial Interests, Institutional, Research Grant: Astellas; Non-Financial Interests, Principal Investigator: Janssen; Non-Financial Interests, Advisory Role: Janssen; Non-Financial Interests, Advisory Role: AstraZeneca; Non-Financial Interests, Principal Investigator: Astellas. L.C. Brown: Financial Interests, Institutional, Research Grant, FOCUS4-C Trial from June 2017 to Dec 2021: AstraZeneca. N. Clarke: Financial Interests, Personal, Invited Speaker: Astellas; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Invited Speaker: Ferring; Financial Interests, Personal, Invited Speaker: Janssen; Financial Interests, Personal, Advisory Board: Astellas; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: Ferring; Financial Interests, Personal, Advisory Board: Janssen; Financial Interests, Institutional, Research Grant: AstraZeneca . W. Cross: Financial Interests, Personal, Invited Speaker, Speaker fee: Myriad Genetics; Financial Interests, Personal, Invited Speaker, Speaker fee: Janssen; Financial Interests, Personal, Advisory Board, Advisory Board fee: Bayer; Financial Interests, Personal, Invited Speaker, Speaker fee: Astellas; Financial Interests, Institutional, Research Grant, Research grant: Myriad Genetics. R. Jones: Financial Interests, Personal, Advisory Board, advisory board attendance: AstraZeneca; Financial Interests, Personal, Advisory Board, advisory board attendance: Astellas; Financial Interests, Personal, Invited Speaker, Honoraria for speaking: Astellas; Financial Interests, Personal, Advisory Board: Bayer; Financial Interests, Personal, Invited Speaker: Bayer; Financial Interests, Personal, Advisory Board: Clovis; Financial Interests, Personal, Advisory Board: Exelixis; Financial Interests, Personal, Advisory Board: Ipsen; Financial Interests, Personal, Invited Speaker: Ipsen; Financial Interests, Personal, Advisory Board: Bristol Myers Squipp; Financial Interests, Personal, Invited Speaker: Bristol Myers Squibb; Financial Interests, Personal, Advisory Board: Merck Serono; Financial Interests, Personal, Invited Speaker: Merck Serono; Financial Interests, Personal, Advisory Board: Merck Sharpe Dome; Financial Interests, Personal, Invited Speaker: Merck Sharpe Dome; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Institutional, Other, IDMC membership: Roche; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Advisory Board: Janssen; Financial Interests, Personal, Invited Speaker: Janssen; Financial Interests, Institutional, Other, IDMC member: Stab; Financial Interests, Personal, Advisory Board: Novartis / AAA; Financial Interests, Institutional, Invited Speaker: Janssen; Financial Interests, Institutional, Invited Speaker: Pfizer; Financial Interests, Institutional, Invited Speaker: Tail; Financial Interests, Institutional, Invited Speaker: AstraZeneca; Financial Interests, Institutional, Invited Speaker: BioXcel; Financial Interests, Institutional, Invited Speaker: Bristol Myers Squibb; Financial Interests, Institutional, Invited Speaker: Novartis / AAA; Financial Interests, Institutional, Invited Speaker: Roche; Financial Interests, Institutional, Invited Speaker: MSK. S. Gillessen: Financial Interests, Personal, Advisory Board, 2018: Sanofi; Financial Interests, Personal, Advisory Board, 2018, 2019: Orion; Financial Interests, Personal, Advisory Board, 2018: Roche; Financial Interests, Personal, Invited Speaker, 2019 Speaker's Bureau: Janssen Cilag; Financial Interests, Personal, Advisory Board, 2020: Amgen; Financial Interests, Personal, Invited Speaker, 2020: ESMO; Financial Interests, Personal, Other, Travel Grant 2020: ProteoMEdiX; Financial Interests, Institutional, Advisory Board, 2018, 2019: Bayer; Financial Interests, Institutional, Advisory Board, 2020: Janssen Cilag; Financial Interests, Institutional, Advisory Board, 2020: Roche; Financial Interests, Institutional, Advisory Board, 2018: AAA International; Financial Interests, Institutional, Advisory Board, 2018: Menarini Silicon Biosystems; Financial Interests, Institutional, Advisory Board, 2019, 2020: Astellas Pharma; Financial Interests, Institutional, Advisory Board, 2019: Tolero Pharmaceuticals; Financial Interests, Institutional, Advisory Board, 2020: MSD Merck Sharp & Dohme; Financial Interests, Institutional, Advisory Board, 2020: Pfizer; Financial Interests, Personal, Invited Speaker, 2021: SAKK; Financial Interests, Institutional, Advisory Board, 2021: Telixpharma; Financial Interests, Institutional, Other, Steering Committee 2021: Amgen; Financial Interests, Institutional, Invited Speaker, 2021: DESO; Financial Interests, Institutional, Advisory Board, 2021: BMS; Financial Interests, Institutional, Advisory Board, 2021: AAA International; Financial Interests, Institutional, Advisory Board, 2021: Orion; Financial Interests, Personal, Invited Speaker, 2021: SAKK; Financial Interests, Personal, Invited Speaker, 2021: SAKK; Financial Interests, Institutional, Advisory Board, 2021: Bayer; Financial Interests, Personal, Advisory Board, 2021: MSD Merck Sharp & Dhome; Financial Interests, Personal, Other, 2021: RSI (Televisione Svizzera Italiana); Financial Interests, Personal, Invited Speaker, 2021: SAMO - IBCSG; Financial Interests, Institutional, Funding, 2021, Unrestricted grant for a Covid related study as co-investigator: Astellas; Non-Financial Interests, Advisory Role, 2019: Menarini Silicon Biosystems; Non-Financial Interests, Advisory Role, 2019: Aranda; Non-Financial Interests, Advisory Role, Continuing: ProteoMediX. S. Chowdhury: Financial Interests, Personal, Advisory Board: Astellas; Financial Interests, Personal, Advisory Board: Janssen; Financial Interests, Personal, Invited Speaker: Janssen; Financial Interests, Personal, Advisory Board: Huma; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Advisory Board: Bayer; Financial Interests, Personal, Invited Speaker: Bayer; Financial Interests, Personal, Advisory Board: Novartis/AAA; Financial Interests, Personal, Advisory Board: Beigene; Financial Interests, Personal, Advisory Board: Remedy Bio; Financial Interests, Personal, Advisory Board: Athenex; Financial Interests, Personal, Advisory Board: Telix; Financial Interests, Personal, Advisory Board: Clovis Oncology; Financial Interests, Personal, Stocks/Shares: Curve Life; Financial Interests, Institutional, Research Grant: Clovis Oncology; Non-Financial Interests, Advisory Role, Non-compensated advice: NHS England; Non-Financial Interests, Advisory Role: NICE NHS England. Z. Malik: Financial Interests, Personal, Advisory Board, advisry board for new hormonal therapy for breast cancer: Sanofi; Other, support to attend meetings or advisory boards in the past: Astellas, Jaansen, Bayer. C. Parker: Financial Interests, Personal, Advisory Board, Education Steering Committee: Bayer; Financial Interests, Personal, Invited Speaker, Speaker at prostate cancer educational events: Janssen; Financial Interests, Personal, Advisory Board, Advisory board on apalutamide: Janssen; Financial Interests, Personal, Advisory Board, Advisory board: Clarity Pharmaceuticals; Financial Interests, Personal, Advisory Board, Advisory board on relugolix: Myovant; Financial Interests, Personal, Advisory Board, Advisory board: ITM Oncologics. M.R. Sydes: Financial Interests, Personal, Invited Speaker, Speaker fees at clinical trial statistics training sessions for clinicians (no discussion of particular drugs): Janssen; Financial Interests, Personal, Invited Speaker, Speaker fees at clinical trial statistics training session for clinicians (no discussion of particular drugs): Eli Lilly; Financial Interests, Institutional, Research Grant, Educational grant and drug for STAMPEDE trial: Astellas; Financial Interests, Institutional, Research Grant, Educational grant and biomarker costs for STAMPEDE trial: Clovis Oncology; Financial Interests, Institutional, Research Grant, Educational grant and drug for STAMPEDE trial: Janssen; Financial Interests, Institutional, Research Grant, Educational grant and drug for STAMPEDE trial: Novartis; Financial Interests, Institutional, Research Grant, Educational grant and drug for STAMPEDE trial: Pfizer; Financial Interests, Institutional, Research Grant, Educational grant and drug for STAMPEDE trial: Sanofi. M.K. Parmar: Financial Interests, Institutional, Research Grant: AstraZeneca, Astellas, Janssen, Clovis. N.D. James: Financial Interests, Personal, Advisory Board, Advice around PARP inhibitors: AstraZeneca; Financial Interests, Personal, Advisory Board, Prostate cancer therapies: Janssen; Financial Interests, Institutional, Expert Testimony, Assisted with submissions regarding licencing for abiraterone: Janssen; Financial Interests, Personal, Advisory Board, Docetaxel: Sanofi; Financial Interests, Institutional, Expert Testimony, Providing STAMPEDE trial data to facilitate licence extensions internationally for docetaxel: Sanofi; Financial Interests, Personal, Advisory Board, Prostate cancer therapies: Clovis; Financial Interests, Personal, Advisory Board, Prostate cancer therapies: Novartis; Financial Interests, Personal, Advisory Board, Bladder cancer therapy: Merck; Financial Interests, Institutional, Invited Speaker, Funding for STAMPEDE trial: Janssen; Financial Interests, Institutional, Invited Speaker, Funding for STAMPEDE trial: Astellas; Financial Interests, Institutional, Invited Speaker, Funding for RADIO trial bladder cancer: AstraZeneca. All other authors have declared no conflicts of interest.
LBA5_PR - A phase III trial with a 2x2 factorial design in men with de novo metastatic castration-sensitive prostate cancer: Overall survival with abiraterone acetate plus prednisone in PEACE-1
- Karim Fizazi (Villejuif, Cedex, France)
Abstract
Background
Since 2015, combining androgen deprivation therapy (ADT) with either docetaxel, androgen signaling inhibitors (ASI), or radiotherapy to the primary tumor (RXT) (for low metastatic burden) was shown to improve overall survival (OS) and has thus become the new standard of care (SOC) in men with mCSPC. It is unknown whether combining those treatments on top of ADT could further increment outcomes. PEACE-1 is a phase 3 trial with a 2x2 factorial design of abiraterone acetate plus prednisone (abiraterone) and/or local radiotherapy. First results show that adding abiraterone to ADT+docetaxel significantly improves rPFS in men with mCSPC (HR: 0.50 (0.40-0.62), p<0.0001) (Fizazi, ASCO 2021).
Methods
1173 men (57% high-, 43% low-volume) with
Results
The median follow-up is 4.4 yrs (n=273 death events in the ADT+docetaxel population). The effect of abiraterone on OS did not interact with the one of RXT (p=0.82) allowing to pool the abiraterone arms together for comparison. OS was improved by abiraterone both in the overall population (HR: 0.83, 95% CI: 0.69-0.99, p=0.034; medians: 5.7 vs 4.7 yrs) and in the ADT+docetaxel population (HR: 0.75, 95% CI: 0.59-0.96, p=0.021; medians: NR vs 4.4 yrs). Among the ADT+docetaxel pts who developed CRPC, 231/263 (88%) then received at least one life-prolonging therapy and 222/263 (84%) at least one ASI in the control arm, compared to 110/141 (78%) and 67/141 (48%) in the abiraterone arm, respectively. Grade 3-5 adverse events reported in >5% of pts in the ADT+docetaxel population included neutropenic fever (5% vs 5%), neutropenia (10% vs 9%), liver toxicity (6% vs 1%) and hypertension (21% vs 13%) in the abiraterone and control arms, respectively.
Conclusions
Adding abiraterone to ADT plus docetaxel improves both rPFS and OS in mCSPC men, even when 84% of mCRPC men from the control arm receive an ASI.
Clinical trial identification
NCT01957436.
Editorial acknowledgement
We thank Sébastien Marion from Unicancer for editing the English.
Legal entity responsible for the study
Unicancer.
Funding
Janssen Pharmaceutical NV, Ipsen, Sanofi, PHRC.
Disclosure
K. Fizazi: Financial Interests, Institutional, Advisory Board: Astellas; Financial Interests, Institutional, Invited Speaker: Astellas; Financial Interests, Institutional, Advisory Board: Bayer; Financial Interests, Institutional, Invited Speaker: Bayer; Financial Interests, Personal, Advisory Board: Curevac; Financial Interests, Institutional, Advisory Board: Janssen; Financial Interests, Institutional, Invited Speaker: Janssen; Financial Interests, Personal, Advisory Board: Orion; Financial Interests, Institutional, Invited Speaker: Sanofi; Financial Interests, Institutional, Advisory Board: AAA; Financial Interests, Institutional, Advisory Board: MSD; Financial Interests, Institutional, Invited Speaker: MSD; Financial Interests, Institutional, Advisory Board: AstraZeneca; Financial Interests, Institutional, Invited Speaker: AstraZeneca; Financial Interests, Institutional, Research Grant, Trial chair: Pfizer; Financial Interests, Institutional, Research Grant, Trial chair: Bayer; Financial Interests, Institutional, Research Grant, Trial chair: AstraZeneca; Financial Interests, Institutional, Research Grant, Trial chair: Orion; Financial Interests, Institutional, Research Grant, Trial chair: MSD; Financial Interests, Institutional, Research Grant, Trial chair: BMS; Financial Interests, Institutional, Research Grant, Trial chair: Janssen. J. Carles Galceran: Financial Interests, Personal, Advisory Board: Astellas; Financial Interests, Personal, Advisory Board: Astrazeneca; Financial Interests, Personal, Advisory Board: Bayer; Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Personal, Advisory Board: Janssen; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: Sanofi; Financial Interests, Personal, Speaker’s Bureau: Astellas; Financial Interests, Personal, Speaker’s Bureau: Bayer; Financial Interests, Personal, Speaker’s Bureau: Janssen. G. Roubaud: Financial Interests, Personal, Invited Speaker: Astellas; Financial Interests, Personal, Invited Speaker: Janssen; Financial Interests, Institutional, Invited Speaker: Sanofi; Financial Interests, Personal, Invited Speaker: Astrazeneca; Financial Interests, Personal, Invited Speaker: Ipsen; Financial Interests, Personal, Invited Speaker: Pfizer. R. McDermott: Financial Interests, Personal, Invited Speaker: Astellas; Financial Interests, Personal, Advisory Board: Amgen; Financial Interests, Personal, Advisory Board: Bayer; Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Personal, Advisory Board: Clovis; Financial Interests, Personal, Invited Speaker: Ipsen; Financial Interests, Personal, Advisory Board: Janssen; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Institutional, Principal Investigator: Astellas; Financial Interests, Institutional, Principal Investigator: Bayer; Financial Interests, Institutional, Principal Investigator: BMS; Financial Interests, Institutional, Principal Investigator: Clovis; Financial Interests, Institutional, Principal Investigator: MSD; Financial Interests, Institutional, Principal Investigator: Regeneron. A. Fléchon: Financial Interests, Personal, Expert Testimony: AAA; Financial Interests, Personal, Expert Testimony: Astrazeneca; Financial Interests, Personal, Expert Testimony: Astellas; Financial Interests, Personal, Expert Testimony: Bayer; Financial Interests, Personal, Expert Testimony: Janssen; Financial Interests, Personal, Expert Testimony: Novartis; Financial Interests, Personal, Expert Testimony: Sanofi. B. Tombal: Financial Interests, Personal, Invited Speaker: Amgen; Financial Interests, Personal, Advisory Board: Amgen; Financial Interests, Personal, Invited Speaker: Astellas; Financial Interests, Personal, Advisory Board: Astellas; Financial Interests, Personal, Advisory Board: Bayer; Financial Interests, Personal, Invited Speaker: Ferring; Financial Interests, Personal, Advisory Board: Janssen; Financial Interests, Personal, Advisory Board: Myovant; Financial Interests, Personal, Advisory Board: Sanofi. S. Supiot: Financial Interests, Personal, Invited Speaker: Takeda; Financial Interests, Personal, Invited Speaker: Sanofi; Financial Interests, Personal, Advisory Board: Astellas; Financial Interests, Personal, Advisory Board: Janssen; Financial Interests, Personal, Advisory Board: Bouchara; Financial Interests, Personal, Advisory Board: Ipsen; Financial Interests, Institutional, Principal Investigator: Astrazeneca; Financial Interests, Institutional, Principal Investigator: Astellas; Financial Interests, Institutional, Principal Investigator: Janssen. D.R. Berthold: Financial Interests, Personal, Advisory Board: Astellas; Financial Interests, Personal, Advisory Board: Janssen; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Advisory Board: Roche. G. Kacso: Financial Interests, Personal, Invited Speaker: Astellas; Financial Interests, Personal, Invited Speaker: Astrazeneca; Financial Interests, Personal, Invited Speaker: Janssen; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Invited Speaker: Sanofi; Financial Interests, Personal, Advisory Board: Astellas; Financial Interests, Personal, Advisory Board: Astrazeneca; Financial Interests, Personal, Advisory Board: Janssen; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: Sanofi; Financial Interests, Personal, Invited Speaker: MSD. G. Gravis Mescam: Financial Interests, Institutional, Advisory Board: BMS; Financial Interests, Institutional, Advisory Board: Janssen; Financial Interests, Institutional, Advisory Board: Pfizer; Financial Interests, Institutional, Advisory Board: Merck; Financial Interests, Institutional, Advisory Board: AAA; Financial Interests, Institutional, Invited Speaker: Astellas; Financial Interests, Institutional, Invited Speaker: MSD; Financial Interests, Institutional, Invited Speaker: Janssen; Financial Interests, Institutional, Invited Speaker: Amgen; Financial Interests, Institutional, Invited Speaker: BMS; Financial Interests, Institutional, Invited Speaker: Sanofi. F. Calabro': Financial Interests, Institutional, Advisory Board: BMS; Financial Interests, Institutional, Advisory Board: MSD; Financial Interests, Institutional, Advisory Board: Pfizer; Financial Interests, Institutional, Advisory Board: Astrazeneca; Financial Interests, Institutional, Invited Speaker: BMS; Financial Interests, Institutional, Invited Speaker: MSD; Financial Interests, Institutional, Invited Speaker: Pfizer. A. Thiery-Vuillemin: Financial Interests, Personal, Advisory Role: Pfizer; Financial Interests, Personal, Advisory Role: Astrazeneca; Financial Interests, Personal, Advisory Role: Sanofi; Financial Interests, Personal, Advisory Role: Janssen; Financial Interests, Personal, Advisory Role: Novartis; Financial Interests, Personal, Advisory Role: Ipsen; Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Advisory Role: BMS; Financial Interests, Personal, Advisory Role: MSD; Financial Interests, Personal, Advisory Role: Astellas. I. Latorzeff: Financial Interests, Personal, Invited Speaker: Astellas; Financial Interests, Personal, Advisory Board: Astellas; Financial Interests, Personal, Invited Speaker: Ipsen; Financial Interests, Personal, Advisory Board: Ipsen; Financial Interests, Personal, Advisory Board: Janssen. A. Bossi: Financial Interests, Institutional, Research Grant: Ipsen; Financial Interests, Institutional, Research Grant: Janssen; Financial Interests, Institutional, Research Grant: Sanofi; Financial Interests, Personal, Advisory Role: Astellas; Financial Interests, Personal, Advisory Role: Bard; Financial Interests, Personal, Advisory Role: Elekta; Financial Interests, Personal, Advisory Role: Ipsen; Financial Interests, Personal, Advisory Role: Myovant; Financial Interests, Personal, Speaker’s Bureau: Astellas; Financial Interests, Personal, Speaker’s Bureau: BMS; Financial Interests, Personal, Speaker’s Bureau: Ferring; Financial Interests, Personal, Speaker’s Bureau: Sanofi; Financial Interests, Personal, Invited Speaker: Janssen. All other authors have declared no conflicts of interest.
Invited Discussant LBA4 and LBA5
- Eleni Efstathiou (Houston, TX, United States of America)
LBA6 - KRYSTAL-1: Adagrasib (MRTX849) as monotherapy or combined with cetuximab (Cetux) in patients (Pts) with colorectal cancer (CRC) harboring a KRASG12C mutation
- Jared Weiss (Chapel Hill, United States of America)
Abstract
Background
KRASG12C mutations, which occur in 3%-4% of CRC, are a negative predictor of cetux efficacy. Adagrasib, an investigational agent, is a KRASG12C inhibitor that irreversibly and selectively binds KRASG12C, locking it in its inactive state; it was optimized for favorable PK properties, including a long half-life (∼24 hours). Durable inhibition of KRASG12C may be particularly important in CRC due to signaling pathways which create a susceptibility to feedback reactivation of KRAS. EGFR signaling is implicated in this reactivation, providing a rational co-targeting strategy for KRAS-mutant CRC.
Methods
KRYSTAL-1 (NCT03785249) is a multicohort Phase 1/2 study evaluating adagrasib in pts with KRASG12C -mutant advanced solid tumors. CRC cohorts include adagrasib 600 mg BID monotherapy (Phase 1/2) and adagrasib 600 mg BID + cetux 400 mg/m2 followed by 250 mg/m2 QW; or 500 mg/m2 Q2W (Phase 1b). Endpoints include safety, PK, and clinical activity. Here we report preliminary monotherapy and cetux combination data.
Results
As of 25 May 2021, 46 pts with CRC (50% female; median age 58 years; 3 median prior lines of therapy) had received adagrasib monotherapy (median follow-up 8.9 months). TRAEs of any grade (gr) occurred in 91% and gr 3/4 events in 30% of pts, with no gr 5 events. Among the 45 pts evaluable for clinical activity, the response rate was 22% (10/45, including 1 unconfirmed PR who remains on study) and DCR was 87% (39/45). Median DOR was 4.2 months; median PFS was 5.6 months. As of 9 July 2021, 32 pts with CRC (53% female; median age 60 years; 3 median prior lines of therapy) were treated with adagrasib + cetux (median follow-up 7 months). TRAEs of any gr occurred in 100% and gr 3/4 events in 16% of pts, with no gr 5 events. Among the 28 pts evaluable for clinical activity, the response rate was 43% (12/28, including 2 unconfirmed PRs who remain on study) and DCR was 100%.
Conclusions
Adagrasib is well tolerated as monotherapy and combined with cetux and demonstrates promising clinical activity in heavily pretreated pts with KRASG12C-mutant CRC. Adagrasib + cetux is currently being evaluated in the 2L setting in a Phase 3 trial of pts with KRASG12C-mutant CRC (NCT04793958).
Clinical trial identification
NCT03785249.
Editorial acknowledgement
Editorial and writing support was provided by Robin Serody of Axiom Healthcare Strategies.
Legal entity responsible for the study
Mirati Therapeutics, Inc.
Funding
Mirati Therapeutics, Inc.
Disclosure
J. Weiss: Financial Interests, Personal, Stocks/Shares: Nektar; Financial Interests, Personal, Stocks/Shares: Vesselon; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: EMD Serono; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: Genentech; Financial Interests, Personal, Advisory Board: Inivata; Financial Interests, Personal, Advisory Board: Celgene; Financial Interests, Personal, Advisory Board: G1 Therapeutics; Financial Interests, Personal, Advisory Board: Jounce Therapeutics; Financial Interests, Personal, Advisory Board: AbbVie; Financial Interests, Personal, Advisory Board: Rakuten Medical; Financial Interests, Personal, Advisory Board: Nanobiotix; Financial Interests, Personal, Advisory Board: Azitra; Financial Interests, Personal, Advisory Board: Lilly; Financial Interests, Personal, Advisory Board: Blueprint Medicines; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Advisory Board: Jazz Pharmaceuticals; Financial Interests, Personal, Advisory Board: Boehringer Ingelheim; Financial Interests, Personal, Advisory Board: Regeneron; Financial Interests, Personal, Advisory Board: Genmab. R.D. Yaeger: Financial Interests, Personal, Advisory Board: Array Biopharma; Financial Interests, Personal, Advisory Board: Natera. M.L. Johnson: Financial Interests, Institutional, Advisory Board: Genentech/Roche; Financial Interests, Institutional, Advisory Board: Boehringer Ingelheim; Financial Interests, Institutional, Advisory Board: Calithera; Financial Interests, Institutional, Advisory Board: AstraZeneca; Financial Interests, Institutional, Advisory Board: Merck; Financial Interests, Institutional, Advisory Board: Loxo; Financial Interests, Institutional, Advisory Board: Sanofi; Financial Interests, Institutional, Advisory Board: Mirati Therapeutics; Financial Interests, Institutional, Advisory Board: Pfizer; Financial Interests, Institutional, Advisory Board: Guardant Health; Financial Interests, Institutional, Advisory Board: Ribon Therapeutics; Financial Interests, Institutional, Advisory Board: Incyte; Financial Interests, Institutional, Advisory Board: AbbVie; Financial Interests, Institutional, Advisory Board: GlaxoSmithKline; Financial Interests, Institutional, Advisory Board: Janssen; Financial Interests, Institutional, Advisory Board: Lilly; Financial Interests, Institutional, Advisory Board: Novartis; Financial Interests, Institutional, Advisory Board: Amgen; Financial Interests, Institutional, Advisory Board: BMS; Financial Interests, Institutional, Advisory Board: Daichi-Sankyo; Financial Interests, Institutional, Advisory Board: EMD Serono; Financial Interests, Institutional, Advisory Board: G1 Therapeutics; Financial Interests, Institutional, Advisory Board: Checkpoint Therapeutics; Financial Interests, Institutional, Advisory Board: Eisai. A. Spira: Financial Interests, Personal, Stocks/Shares: Lilly; Financial Interests, Personal, Advisory Board: Array Biopharma; Financial Interests, Personal, Advisory Board: Incyte; Financial Interests, Personal, Advisory Board: Amgen; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: AstraZeneca/MedImmune; Financial Interests, Personal, Advisory Board: Mirati Therapeutics; Financial Interests, Personal, Advisory Board: Gritstone Oncology; Financial Interests, Personal, Advisory Board: Jazz Pharmaceuticals; Financial Interests, Personal, Advisory Board: Merck; Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Personal, Other: CytomX Therapeutics; Financial Interests, Personal, Other: Takeda; Financial Interests, Personal, Other: Amgen; Financial Interests, Personal, Other: Janssen; Financial Interests, Personal, Other: Bayer. S.J. Klempner: Financial Interests, Personal, Advisory Board: Lilly; Financial Interests, Personal, Advisory Board: Boston Biomedical; Financial Interests, Personal, Advisory Board: Astellas Pharma; Financial Interests, Personal, Advisory Board: Foundation Medicine; Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Personal, Advisory Board: Pieris Pharmaceuticals; Financial Interests, Personal, Advisory Board: Merck; Financial Interests, Personal, Advisory Board: Daichi Sankyo/UCB Japan; Financial Interests, Personal, Speaker’s Bureau: Foundation Medicine; Financial Interests, Personal, Stocks/Shares: TP Therapeutics. J.G. Christensen: Financial Interests, Personal, Full or part-time Employment: Mirati Therapeutics, Inc; Financial Interests, Personal, Advisory Role: BridgeBio; Financial Interests, Personal, Leadership Role: Mirati Therapeutics; Financial Interests, Personal, Leadership Role: BCTG Acquisition Corporation; Financial Interests, Personal, Stocks/Shares: Mirati Therapeutics; Financial Interests, Personal, Stocks/Shares: Bluebird Bio; Financial Interests, Personal, Stocks/Shares: BCTG Acquisition Corp. A. Chi: Financial Interests, Personal, Full or part-time Employment: Mirati Therapeutics, Inc; Financial Interests, Personal, Stocks/Shares: Mirati Therapeutics, Inc. H. Der-Torossian: Non-Financial Interests, Personal, Full or part-time Employment: Mirati Therapeutics, Inc. K. Velastegui: Other, Personal, Full or part-time Employment: Mirati Therapeutics, Inc. T. Kheoh: Financial Interests, Personal, Full or part-time Employment: Mirati Therapeutics, Inc; Financial Interests, Personal, Stocks/Shares: Mirati Therapeutics, Inc; Financial Interests, Personal, Stocks/Shares: Tocagen. S.I. Ou: Financial Interests, Personal, Advisory Role: Pfizer; Financial Interests, Personal, Advisory Role: Roche/Genentech; Financial Interests, Personal, Advisory Role: Takeda; Financial Interests, Personal, Advisory Role: Janssen Oncology; Financial Interests, Personal, Speaker’s Bureau: AstraZeneca; Financial Interests, Personal, Speaker’s Bureau: Roche/Genentech; Financial Interests, Personal, Stocks/Shares: Turning Point Therapeutics; Financial Interests, Personal, Stocks/Shares: Elevation Oncology. All other authors have declared no conflicts of interest.
Invited Discussant LBA6
- Federica Di Nicolantonio (Torino, (TO), Italy)
LBA7 - Nivolumab (NIVO) plus chemotherapy (Chemo) or ipilimumab (IPI) vs chemo as first-line (1L) treatment for advanced gastric cancer/gastroesophageal junction cancer/esophageal adenocarcinoma (GC/GEJC/EAC): CheckMate 649 study
- Yelena Y. Janjigian (New York, NY, United States of America)
Abstract
Background
CheckMate 649, a randomized, global phase 3 study of 1L programmed death (PD) 1 inhibitor-based therapies in advanced GC/GEJC/EAC, demonstrated superior overall survival (OS) with NIVO + chemo vs chemo, leading to US FDA approval. We report longer-term follow-up for NIVO + chemo vs chemo and first results for NIVO + IPI vs chemo.
Methods
Adults with previously untreated, unresectable advanced or metastatic GC/GEJC/EAC were enrolled regardless of PD-ligand 1 (PD-L1) expression. Patients (pts) with known HER2-positive status were excluded. Pts were randomized to NIVO (360 mg Q3W or 240 mg Q2W) + chemo (XELOX Q3W or FOLFOX Q2W), NIVO 1 mg/kg + IPI 3 mg/kg Q3W (4 doses, then NIVO 240 mg Q2W), or chemo. Dual primary endpoints were OS and progression-free survival (PFS; per blinded independent central review [BICR]) for NIVO + chemo vs chemo in pts with PD-L1 combined positive score (CPS) ≥ 5. Hierarchically tested secondary endpoints included OS in NIVO + chemo vs chemo (PD-L1 CPS ≥ 1, then all randomized) and OS in NIVO + IPI vs chemo (PD-L1 CPS ≥ 5, then all randomized).
Results
Of 2031 pts, 1581 (60% with PD-L1 CPS ≥ 5) were concurrently randomized to NIVO + chemo or chemo and 813 (58% with PD-L1 CPS ≥ 5) to NIVO + IPI or chemo. NIVO + chemo continued to show improvement in OS vs chemo alone with an additional 12-mo follow-up from the primary analysis (Table). The secondary endpoint of OS in pts with PD-L1 CPS ≥ 5 for NIVO + IPI vs chemo group was not met (minimum follow-up, 35.7 mo; Table); other endpoints in the hierarchy were not tested. No new safety signals were identified. Additional results are shown in the table.
Conclusions
NIVO + chemo continued to demonstrate clinically meaningful long-term survival benefit vs chemo and an acceptable safety profile with additional follow-up, further supporting its use as a new standard 1L treatment in pts with advanced GC/GEJC/EAC. aPer BICR m, median; ORR, objective response rate; TRAE, treatment-related adverse event
NIVO + chemo Chemo NIVO + IPI Chemo 14.4 (13.1–16.2) 11.1 (10.0–12.1) 11.2 (9.2–13.4) 11.6 (10.1–12.7) HR 0.70 (95% CI 0.61–0.81) 0.89 (96.5% CI 0.71–1.10; % (95% CI) 60 (55-65) 45 (40-50) 27 (20-33) 47 (40-54) 13.8 (12.4–14.5) 11.6 (10.9–12.5) 11.7 (9.6–13.5) 11.8 (11.0–12.7) HR 0.79 (95% CI 0.71–0.88) 0.91 (96.5% CI 0.77–1.07; Any 95 89 80 92 Grade 3–4 60 45 38 46 Led to discontinuation 38 25 22 26
Clinical trial identification
NCT02872116.
Editorial acknowledgement
Writing and editorial assistance was provided by Puneet Dang, PhD of Parexel International, funded by Bristol Myers Squibb.
Legal entity responsible for the study
Bristol Myers Squibb.
Funding
Bristol Myers Squibb.
Disclosure
Y.Y. Janjigian: Financial Interests, Personal, Other, Consulting fees: Bristol Myers Squibb; Financial Interests, Personal, Other, Consulting fees: Merck Serono; Financial Interests, Personal, Other, Consulting fees: RGENIX; Financial Interests, Personal, Other, Consulting fees: Eli Lilly; Financial Interests, Personal, Other, Consulting fees: Daiichi Sankyo; Financial Interests, Personal, Other, Consulting fees: Pfizer; Financial Interests, Personal, Other, Consulting fees: Bayer; Financial Interests, Personal, Other, Consulting fees: Imugene; Financial Interests, Personal, Other, Consulting fees: Merck; Financial Interests, Personal, Other, Consulting fees: Zymeworks; Financial Interests, Personal, Other, Consulting fees: Seattle Genetics; Financial Interests, Personal, Other, Consulting fees: Basilea Pharmaceutica; Financial Interests, Personal, Other, Consulting fees: AstraZeneca; Financial Interests, Personal, Stocks/Shares: RGENIX; Financial Interests, Personal, Research Grant: NCI, Department of Defense, Cycle for Survival, Fred’s Team; Financial Interests, Personal, Research Grant: RGENIX; Financial Interests, Personal, Research Grant: Bayer; Financial Interests, Personal, Research Grant: Genentech/Roche; Financial Interests, Personal, Research Grant: Bristol Myers Squibb; Financial Interests, Personal, Research Grant: Eli Lilly; Financial Interests, Personal, Research Grant: Merck. J.A. Ajani: Financial Interests, Personal, Other, Consulting or Advisory Role: American Cancer Society; Financial Interests, Personal, Other, Consulting or Advisory Role: BeiGene; Financial Interests, Personal, Other, Consulting or Advisory Role: Vaccinogen; Financial Interests, Personal, Other, Consulting or Advisory Role: Insys Therapeutics; Financial Interests, Personal, Other, Consulting or Advisory Role: Merck; Financial Interests, Personal, Other, Consulting or Advisory Role: Bristol Myers Squibb; Financial Interests, Personal, Research Grant: Genentech; Financial Interests, Personal, Research Grant: Roche; Financial Interests, Personal, Research Grant: Bristol Myers Squibb; Financial Interests, Personal, Research Grant: Taiho; Financial Interests, Personal, Research Grant: MedImmune; Financial Interests, Personal, Research Grant: Merck; Financial Interests, Personal, Research Grant: Amgen; Financial Interests, Personal, Research Grant: Lilly; Financial Interests, Personal, Other, Honoraria: Lilly; Financial Interests, Personal, Other, Honoraria: Bristol Myers Squibb; Financial Interests, Personal, Other, Honoraria: Merck; Financial Interests, Personal, Other, Honoraria: Aduro Biotech; Financial Interests, Personal, Other, Honoraria: DAVA Pharmaceuticals; Financial Interests, Personal, Other, Honoraria: AstraZeneca; Financial Interests, Personal, Other, Honoraria: Acrotech Biopharma; Financial Interests, Personal, Other, Honoraria: Zymeworks; Financial Interests, Personal, Other, Honoraria: Astellas Pharma; Financial Interests, Personal, Other, Honoraria: Amgen; Financial Interests, Personal, Other, Honoraria: Daiichi Sankyo; Financial Interests, Personal, Research Grant: Novartis; Financial Interests, Personal, Research Grant: Bristol Myers Squibb; Financial Interests, Personal, Research Grant: Taiho Pharmaceutical; Financial Interests, Personal, Research Grant: Roche/Genentech; Financial Interests, Personal, Research Grant: Amgen; Financial Interests, Personal, Research Grant: Lilly/ImClone; Financial Interests, Personal, Research Grant: Merck; Financial Interests, Personal, Research Grant: Delta-Fly Pharma; Financial Interests, Personal, Research Grant: Gilead Sciences; Financial Interests, Personal, Research Grant: Takeda; Financial Interests, Personal, Research Grant: ProLynx; Financial Interests, Personal, Research Grant: Zymeworks; Financial Interests, Personal, Research Grant: Daiichi Sankyo; Financial Interests, Institutional, Research Grant: Astellas Pharma. M. Moehler: Financial Interests, Personal, Other, Consulting or Advisory Role: Bayer; Financial Interests, Personal, Other, Consulting or Advisory Role: MSD; Financial Interests, Personal, Other, Consulting or Advisory Role: Merck Serono; Financial Interests, Personal, Other, Consulting or Advisory Role: Amgen; Financial Interests, Personal, Other, Consulting or Advisory Role: Taiho Pharmaceutical; Financial Interests, Personal, Other, Consulting or Advisory Role: Pfizer; Financial Interests, Personal, Other, Consulting or Advisory Role: Roche; Financial Interests, Personal, Other, Consulting or Advisory Role: Lilly; Financial Interests, Personal, Other, Consulting or Advisory Role: Servier; Financial Interests, Personal, Other, Consulting or Advisory Role: BeiGene; Financial Interests, Personal, Other, Consulting or Advisory Role: Bristol Myers Squibb; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Amgen; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Merck Serono; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Roche; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Bayer; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: ASCO; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: German Cancer Society; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: MSD; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: ESMO; Financial Interests, Personal, Other, Honoraria: Amgen; Financial Interests, Personal, Other, Honoraria: Roche/Genentech; Financial Interests, Personal, Other, Honoraria: Merck Serono; Financial Interests, Personal, Other, Honoraria: MSD Oncology; Financial Interests, Personal, Other, Honoraria: Bristol Myers Squibb; Financial Interests, Personal, Other, Honoraria: AstraZeneca/MedImmune; Financial Interests, Personal, Other, Honoraria: Servier; Financial Interests, Personal, Other, Honoraria: Pierre Fabre; Financial Interests, Personal, Other, Honoraria: Sanofi; Financial Interests, Institutional, Research Grant: Amgen; Financial Interests, Institutional, Research Grant: Leap Therapeutics; Financial Interests, Institutional, Research Grant: Merck Serono; Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Institutional, Research Grant: MSD. M. Garrido: Financial Interests, Institutional, Research Grant: Bristol Myers Squibb; Financial Interests, Personal, Other, Consulting Fee: Roche; Financial Interests, Personal, Expert Testimony: AstraZeneca; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: MSD; Financial Interests, Personal, Advisory Board: Roche. C. Gallardo: Financial Interests, Personal, Other, Consulting Fee: Roche; Financial Interests, Personal, Other, Consulting Fee: AstraZeneca; Financial Interests, Personal, Other, Consulting Fee: MSD; Financial Interests, Personal, Other, Consulting Fee: Novartis; Financial Interests, Personal, Other, Honoraria: Novartis; Financial Interests, Personal, Other, Honoraria: AstraZeneca; Financial Interests, Personal, Other, Honoraria: MSD; Financial Interests, Personal, Expert Testimony: Novartis; Financial Interests, Personal, Expert Testimony: AstraZeneca; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Roche; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: MSD; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Advisory Board: Novartis. L. Shen: Financial Interests, Institutional, Research Grant: Beijing Xiantong Biomedical Technology; Financial Interests, Institutional, Research Grant: Qilu Pharmaceutical; Financial Interests, Institutional, Research Grant: ZaiLab Pharmaceutical (Shanghai); Financial Interests, Institutional, Research Grant: Beihai Kangcheng(Beijing)Medical Technology; Financial Interests, Institutional, Research Grant: Jacobio Pharmaceuticals; Financial Interests, Institutional, Research Grant: Beijing Xiantong; Financial Interests, Institutional, Research Grant: Biomedical Technology; Financial Interests, Personal, Other, Consulting fee: MSD; Financial Interests, Personal, Other, Consulting fee: Merk; Financial Interests, Personal, Other, Consulting fee: Mingji biopharmaceutical; Financial Interests, Personal, Other, Consulting fee: Haichuang pharmaceutical; Financial Interests, Personal, Other, Consulting fee: Herbour biomed; Financial Interests, Personal, Other, Consulting fee: BI; Financial Interests, Personal, Speaker’s Bureau: Hutchison Whampoa; Financial Interests, Personal, Speaker’s Bureau: Hengrui; Financial Interests, Personal, Speaker’s Bureau: ZaiLab; Financial Interests, Personal, Speaker’s Bureau: CSTONE pharmaceutical; Financial Interests, Personal, Advisory Board: Rongchang pharmaceutical; Financial Interests, Personal, Advisory Board: ZaiLab; Financial Interests, Personal, Advisory Board: CSTONE pharmaceutical; Financial Interests, Personal, Advisory Board: Bristol Myers Squibb. K. Yamaguchi: Financial Interests, Personal, Other, Consulting or Advisory Role: Bristol Myers Squibb; Financial Interests, Personal, Other, Consulting or Advisory Role: Daiichi Sankyo; Financial Interests, Personal, Speaker’s Bureau: Chugai Pharma; Financial Interests, Personal, Speaker’s Bureau: Bristol Myers Squibb Japan; Financial Interests, Personal, Speaker’s Bureau: Takeda; Financial Interests, Personal, Speaker’s Bureau: Taiho Pharmaceutical; Financial Interests, Personal, Speaker’s Bureau: Lilly; Financial Interests, Personal, Speaker’s Bureau: Ono Pharmaceutical; Financial Interests, Personal, Speaker’s Bureau: Daiichi Sankyo; Financial Interests, Personal, Speaker’s Bureau: Merck; Financial Interests, Institutional, Research Grant: Ono Pharmaceutical; Financial Interests, Institutional, Research Grant: Taiho Pharmaceutical; Financial Interests, Institutional, Research Grant: Daiichi Sankyo; Financial Interests, Institutional, Research Grant: Lilly; Financial Interests, Institutional, Research Grant: Gilead Sciences; Financial Interests, Institutional, Research Grant: Yakult Honsha; Financial Interests, Institutional, Research Grant: Chugai Pharma; Financial Interests, Institutional, Research Grant: Boehringer Ingelheim; Financial Interests, Institutional, Research Grant: Eisai; Financial Interests, Institutional, Research Grant: MSD Oncology; Financial Interests, Institutional, Research Grant: Sanofi; Financial Interests, Institutional, Research Grant: Bristol Myers Squibb. L. Wyrwicz: Financial Interests, Personal, Other, Consulting or Advisory Role: Amgen; Financial Interests, Personal, Other, Consulting or Advisory Role: Servier; Financial Interests, Personal, Speaker’s Bureau: Amgen; Financial Interests, Personal, Speaker’s Bureau: Roche; Financial Interests, Personal, Speaker’s Bureau: Sanofi Aventis; Financial Interests, Personal, Speaker’s Bureau: Servier; Financial Interests, Personal, Other, Patents, Royalties, Other Intellectual Property: National Cancer Research Institute. M. Tehfe: Financial Interests, Personal, Other, Consultancy or Advisory: Celgene; Financial Interests, Personal, Other, Consultancy or Advisory: Merck; Financial Interests, Personal, Other, Consultancy or Advisory: Taiho Pharmaceutical; Financial Interests, Personal, Other, Consultancy or Advisory: AstraZeneca; Financial Interests, Personal, Other, Consultancy or Advisory: Takeda; Financial Interests, Personal, Other, Consultancy or Advisory: Bayer; Financial Interests, Personal, Other, Consultancy or Advisory: Bristol Myers Squib; Financial Interests, Personal, Other, Consultancy or Advisory: Eisai; Financial Interests, Personal, Speaker’s Bureau: Celgene; Financial Interests, Personal, Other, Honoraria: Celgene; Financial Interests, Personal, Other, Honoraria: Bristol Myers Squibb; Financial Interests, Personal, Other, Honoraria: Merck; Financial Interests, Personal, Other, Honoraria: Taiho Pharmaceutical; Financial Interests, Personal, Other, Honoraria: Eisai; Financial Interests, Personal, Research Grant: Celgene. E. Elimova: Financial Interests, Personal, Research Grant: Bristol Myers Squibb; Financial Interests, Personal, Research Grant: Zymeworks; Financial Interests, Institutional, Other, Consulting fees: Adaptimmune; Financial Interests, Institutional, Advisory Board: Bristol Myers Squibb; Financial Interests, Institutional, Advisory Board: Zymeworks; Financial Interests, Personal, Other, Spouse employee: Merck Vaccines. M. Li: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb; Financial Interests, Personal, Stocks/Shares: Bristol Myers Squibb; Financial Interests, Personal, Other, Honoraria: Bristol Myers Squibb; Financial Interests, Personal, Other, Travel, accommodations, expenses: Bristol Myers Squibb. V. Poulart: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb. M. Lei: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb; Financial Interests, Personal, Stocks/Shares: Bristol Myers Squibb; Financial Interests, Personal, Other, Patent, Royalties, Other intellectual property: Bristol Myers Squibb. K. Kondo: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb; Financial Interests, Personal, Stocks/Shares: Bristol Myers Squibb; Financial Interests, Other, Travel, accommodations, expenses: Bristol Myers Squibb. K. Shitara: Financial Interests, Personal, Advisory Board: Eli Lilly and Company; Financial Interests, Personal, Advisory Board: Bristol Myers Squibb; Financial Interests, Personal, Advisory Board: Takeda Pharmaceuticals; Financial Interests, Personal, Advisory Board: Pfizer Inc; Financial Interests, Personal, Advisory Board: Ono Pharmaceutical; Financial Interests, Personal, Research Grant: Ono Pharmaceutical; Financial Interests, Personal, Other, Honoraria (lecture fee): Novartis; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: Astellas Pharma; Financial Interests, Personal, Research Grant: Astellas Pharma; Financial Interests, Personal, Research Grant: Eli Lilly and Company; Financial Interests, Personal, Other, Honoraria (lecture fee): AbbVie Inc; Financial Interests, Personal, Advisory Board: AbbVie Inc; Financial Interests, Personal, Other, Honoraria (lecture fee): Yakult; Financial Interests, Personal, Research Grant: Dainippon Sumitomo Pharma; Financial Interests, Personal, Research Grant: Daiichi Sankyo; Financial Interests, Personal, Advisory Board: Daiichi Sankyo; Financial Interests, Personal, Advisory Board: Taiho Pharmaceutical; Financial Interests, Personal, Research Grant: Taiho Pharmaceutical; Financial Interests, Personal, Research Grant: Chugai Pharma; Financial Interests, Personal, Advisory Board: Merck Pharmaceutical; Financial Interests, Personal, Research Grant: Merck Pharmaceutical; Financial Interests, Personal, Research Grant: Medi Science; Financial Interests, Personal, Advisory Board: GlaxoSmithKline; Financial Interests, Personal, Advisory Board: Amgen; Financial Interests, Personal, Advisory Board: Boehringer Ingelheim; Financial Interests, Personal, Research Grant: Eisai. All other authors have declared no conflicts of interest.
Invited Discussant LBA7
- Florian Lordick (Leipzig, Germany)