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KEYNOTE-059 Update: Efficacy and Safety of Pembrolizumab Alone or in Combination With Chemotherapy in Patients With Advanced Gastric or Gastroesophageal (G/GEJ) cancer

Date

08 Sep 2017

Session

Gastrointestinal tumours, non-colorectal 1

Presenters

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

Author affiliations

  • 1 Medicine Hematology And Oncology, David Geffen School of Medicine at UCLA, 90095 - Los Angeles/US
  • 2 Internal Medicine, Indiana University School of Medicine, Indianapolis/US
  • 3 Clinical Oncology, Aichi Cancer Center Hospital, 464-8681 - Nagoya/JP
  • 4 Medical Oncology, Mayo Clinic, 55905 - Rochester/US
  • 5 Hemato-oncology, Pontificia Universidad Catolica de Chile, 750-0000 - Santiago/CL
  • 6 Oncology Division, Sheba Medical Center and Sackler School of Medicine, Tel Aviv/IL
  • 7 Experimental Therapeutics, National Cancer Center Hospital East, Chiba/JP
  • 8 Medicine, University of Chicago Medicine, 60637 - Chicago/US
  • 9 Oncology Division, Tel-Aviv Sourasky Medical Center, 64239 - Tel Aviv/IL
  • 10 Gastrointestinal Oncology Service, Department Of Medicine, Memorial Sloan Kettering Cancer Center, New York/US
  • 11 Medical Oncology, Sanford Health, Sioux Falls/US
  • 12 Internal Medicine, Seoul National University Hospital, Seoul/KR
  • 13 Medical Oncology, Saitama Cancer Center, Saitama/JP
  • 14 Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul/KR
  • 15 Merck Research Laboratory, Merck & Co., Inc., Kenilworth/US
  • 16 Cancer Prevention And Control, Yale Cancer Center, New Haven/US
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Background

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.

Methods

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.

Results

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%).

Conclusions

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

NCT02335411

Legal entity responsible for the study

Merck & Co, Inc.

Funding

Merck & Co, Inc.

Disclosure

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.

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