LBA28_PR - KEYNOTE-059 Update: Efficacy and Safety of Pembrolizumab Alone or in Combination With Chemotherapy in Patients With Advanced Gastric or Gastroesoph...

Date 08 September 2017
Event ESMO 2017 Congress
Session Gastrointestinal tumours, non-colorectal 1
Topics Immunotherapy
Gastrointestinal Cancers
Oesophageal Cancer
Gastric Cancer
Presenter Zev Wainberg
Citation Annals of Oncology (2017) 28 (suppl_5): v616-v617. 10.1093/annonc/mdx440.220
Authors Z.A. Wainberg1, S. Jalal2, K. Muro3, H.H. Yoon4, M. Garrido5, T. Golan6, T. Doi7, D.V. Catenacci8, R. Geva9, G. Ku10, J. Bleeker11, Y. Bang12, H. Hara13, H.C. Chung14, M. Savage15, J. Wang15, M. Koshiji15, R. Dalal15, C.S. Fuchs16
  • 1Medicine Hematology And Oncology, David Geffen School of Medicine at UCLA, 90095 - Los Angeles/US
  • 2Internal Medicine, Indiana University School of Medicine, Indianapolis/US
  • 3Clinical Oncology, Aichi Cancer Center Hospital, 464-8681 - Nagoya/JP
  • 4Medical Oncology, Mayo Clinic, 55905 - Rochester/US
  • 5Hemato-oncology, Pontificia Universidad Catolica de Chile, 750-0000 - Santiago/CL
  • 6Oncology Division, Sheba Medical Center and Sackler School of Medicine, Tel Aviv/IL
  • 7Experimental Therapeutics, National Cancer Center Hospital East, Chiba/JP
  • 8Medicine, University of Chicago Medicine, 60637 - Chicago/US
  • 9Oncology Division, Tel-Aviv Sourasky Medical Center, 64239 - Tel Aviv/IL
  • 10Gastrointestinal Oncology Service, Department Of Medicine, Memorial Sloan Kettering Cancer Center, New York/US
  • 11Medical Oncology, Sanford Health, Sioux Falls/US
  • 12Internal Medicine, Seoul National University Hospital, Seoul/KR
  • 13Medical Oncology, Saitama Cancer Center, Saitama/JP
  • 14Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul/KR
  • 15Merck Research Laboratory, Merck & Co., Inc., Kenilworth/US
  • 16Cancer Prevention And Control, Yale Cancer Center, New Haven/US



Prior results from the global, phase 2 KEYNOTE-059 study (NCT02335411) demonstrated manageable safety and promising antitumor activity for pembro alone and pembro + chemo in pts with G/GEJ cancer.


Pts with recurrent or metastatic G/GEJ adenocarcinoma were enrolled. Pts were enrolled in cohorts 1 and 2 regardless of tumor PD-L1 expression; only pts with PD-L1-positive tumors (combined positive score of ≥ 1% using the PD-L1 IHC 22C3 pharmDx assay) were enrolled in cohort 3. Cohort 1 pts received pembro alone after ≥2 prior lines of therapy. Cohort 2 pts received pembro + cisplatin (80 mg/m2 day 1) + 5-fluorouracil (800 mg/m2 days 1-5 Q3W) or capecitabine (in Japan only, 1000 mg/m2 twice daily) as first-line. Cohort 3 pts received pembro alone as first-line. In all cohorts, pembro was given at 200 mg Q3W for up to 2 years. Primary end points were safety (all) and ORR by RECIST v1.1 by central review (cohorts 1 and 3); key secondary end points were ORR (cohort 2) and DOR by RECIST v1.1, PFS, and OS.


At data cutoff (Apr 21, 2017), median (range) follow-up was 6 (1-25), 14 (2-24), and 18 (2-21) months for cohorts 1 (259 pts), 2 (25 pts) and 3 (31 pts), respectively. Confirmed ORR (95% CI) was 12% (8-17) overall, 16% (11-23) in PD-L1-positive, and 6% (3-13) in PD-L1-negative tumors in cohort 1. Confirmed ORR was 60% (39-79) overall, 73% (45-92) in PD-L1-positive, and 38% (9-76) in PD-L1-negative tumors in cohort 2. In cohort 3, confirmed ORR (95% CI) was 26% (12-45). Median PFS (95% CI) was 2 (2-2), 7 (6-11), and 3 (2-6) months in cohorts 1, 2, and 3, respectively. Median OS (95% CI) in months was 6 (4-7), 14 (9-not estimable), and not reached (9-21) in cohorts 1, 2, and 3, respectively. In cohorts 1, 2 and 3, grade 3-5 treatment-related adverse event (TRAE) incidence was 46 (18%), 19 (76%), and 7 (23%), respectively. In cohort 1, TRAEs led to discontinuation in 7 pts (3%) and death in 2 pts (1%); in cohort 2, TRAEs led to discontinuation in 3 pts (12%); in cohort 3, TRAEs led to death in 1 pt (3%).


These updated results show manageable safety and promising antitumor activity for pembro alone and pembro + chemo in pts with advanced G/GEJ cancer.

Clinical trial identification


Legal entity responsible for the study

Merck & Co, Inc.


Merck & Co, Inc.


Z.A. Wainberg: Consultant for Genetech, Array, Sirtex, Novartis, and Five Prime Therapeutics. S. Jalal: Research funding: AstraZeneca. K. Muro: Research funding: Shionogi & Co, MSD K.K., Daiichi Sankyo, Kyowa Hakko Kirin,. Gilead Sciences Honoraria: Chugai Pharmaceutical, Takeda Pharmaceutical, Eli Lilly Japan K.K., Merck Serono, Taiho, Yakult Honsha. T. Doi: Advisory board: Lilly, Chugai Pharma, Kyowa Hakko, Kirin, Novartis, MSD, Daiichi Sankyo, Amgen Research funding: Taiho, Novartis, Merck Serono, Astellas, MSD, Janssen Pharma, Behringer Ingelheim, Takeda, Pfizer, Lilly, Sumitomo Group, Chugai Pharma, Bayer, Kyowa Hakko, Kirin, Daiichi Sankyo, Celegene. D.V. Catenacci: Advisory board: Merck, BMS, Lilly, Genentech Honoraria: Merck, BMS, Lilly, Genentech Travel expenses, including accommodations: Merck, BMS, Lilly, Genentech. R. Geva: Advisory board: Bayer, MSD, Novartis Honoraria: BMS, Lilly, Medison, Roche, Novartis, Janssen Travel expenses: Roche, BMS. G. Ku: Advisory board member: Merck Research funding: Merck (to institution) Travel expenses: Merck J. Bleeker: Travel expenses: Merck & Co., Inc. Consultant fee: BMS. Y-J. Bang: Advisory board: AstraZeneca, Novartis, Roche, Genentech, MSD, Pfizer, Bayer, BMS, Eli Lilly, Merck Serano, FivePrime, Merrimack, Taiho, Ono, ADC Therapeutics, GreenCross, Samyang Biopharm Research funding: AstraZeneca, Novartis, Genentech/Roche, MSD, Merck Serano, Bayer, GSK, BMS, Pfizer, Eli Lilly, Boeringer-Ingelheim, MacroGenics, Boston Biomedical, FivePrime, CKD, Ono, Otsuka, Taiho, Takeda, BeiGene, Hanmi, Green Cross, Curis. H. Hara: Research funding to institution: AstraZenaca, Chugai Pharma, Merck Serono, MSD, Ono Pharmaceutical, Taiho Pharmaceutical, Takeda, Boehringer Ingelheim, Dainippon Sumitomo Pharma, Daiichi Sankyo, Lilly Honoraria: Chugai Pharma, Taiho Pharmaceuticals, Merck Serono, Yakult Honsha, Lilly. M. Savage, J. Wang, M. Koshiji, R. Dalal: Employment: Merck & Co., Inc. C.S. Fuchs: Advisory board: Eli Lilly, Entrinsic Health, Genentech, Merck, Gilead, Sanofi, Dicerna, Five Prime Therapeutics, Merrimack, Bayer, Agios, Taiho. All other authors have declared no conflicts of interest.