Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

e-Poster Display Session

197TiP - A randomized, double-blind, phase III study of pembrolizumab plus chemotherapy as first-line therapy in patients with HER2-negative, advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma: KEYNOTE-859


22 Nov 2020


e-Poster Display Session


Cytotoxic Therapy

Tumour Site

Oesophageal Cancer;  Gastric Cancer


Shukui Qin


Annals of Oncology (2020) 31 (suppl_6): S1287-S1318. 10.1016/annonc/annonc356


S. Qin1, J. Tabernero2, E. van Cutsem3, C.S. Fuchs4, Y. Janjigian5, P. Bhagia6, K. Li6, D. Adelberg6, Y. Bang7

Author affiliations

  • 1 Pla Cancer Center, Nanjing Jinling Hospital, 210002 - Nanjing/CN
  • 2 Medical Oncology Department, Vall d'Hebron University Hospital, 8035 - Barcelona/ES
  • 3 Digestive Oncology, University Hospitals Leuven - Campus Gasthuisberg, 3000 - Leuven/BE
  • 4 Medical Oncology, Yale Cancer Center and Smilow Cancer Hospital, New Haven/US
  • 5 Medical Oncology, Memorial Sloan Kettering Cancer Center, New York/US
  • 6 Medical Oncology, Merck & Co., Inc., 07033 - Kenilworth/US
  • 7 Internal Medicine (medical Oncology), Seoul National University College, 110-744 - Seoul/KR


Login to get immediate access to this content.

If you do not have an ESMO account, please create one for free.

Abstract 197TiP


For patients with HER2–negative recurrent or metastatic G/GEJ cancer, standard first-line therapy includes a fluoropyrimidine + a platinum-based agent. Accumulating evidence has shown that PD-1 inhibitor pembrolizumab + chemotherapy can improve clinical outcomes in this population. The phase III KEYNOTE-859 trial (NCT03675737) is investigating first-line pembrolizumab + chemotherapy in patients with advanced G/GEJ cancer.

Trial design

Eligible patients are ≥18 years old with previously untreated HER2–negative advanced G/GEJ adenocarcinoma, measurable disease per RECIST v1.1, adequate tumor tissue sample for PD-L1 biomarker analysis, and ECOG performance status 0 or 1. Patients will be randomly assigned 1:1 to pembrolizumab 200 mg or placebo intravenously (IV) every 3 weeks (Q3W) in combination with the investigator’s choice of FP (continuous infusion of 5-fluorouracil [800 mg/m2/day on days 1-5 of each cycle] + IV cisplatin [80 mg/m2] Q3W) or CAPOX (oral capecitabine [1000 mg/m2 twice daily on days 1-14 of each cycle] + IV oxaliplatin [130 mg/m2 on day 1 of each cycle] Q3W). Duration of cisplatin or oxaliplatin may be capped at 6 cycles per local country guidelines; treatment with 5-fluorouracil or capecitabine may continue per protocol. Treatment with pembrolizumab/placebo will continue for up to 35 administrations (∼2 years) or until disease progression, unacceptable toxicity, intercurrent illness that prevents further administration of treatment, or noncompliance. Patients will be stratified by geographic region (Europe/Israel/North America/Australia vs Asia vs rest of world), PD-L1 tumor expression status (combined positive score <1 vs ≥1), and combination chemotherapy (FP vs CAPOX). Imaging will be performed Q6W, and adverse events (AEs) will be monitored throughout the study and for 30 days after treatment (90 days for serious AEs). The dual primary end points are OS and PFS per RECIST v1.1 as assessed by blinded independent central review (BICR). Secondary end points include ORR and DOR per RECIST v1.1 as assessed by BICR and safety. Enrollment is ongoing.

Clinical trial identification


Legal entity responsible for the study

Merck Sharp and Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.


Funding for this study was provided by Merck Sharp and Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.


J. Tabernero: Advisory/Consultancy: Array Biopharma, AstraZeneca, Bayer, BeiGene, Boehringer Ingelheim, Chugai, Genentech, Inc., Genmab A/S, Halozyme, Imugene Limited, Inflection Biosciences Limited, Ipsen, Kura Oncology, Lilly, MSD, Menarini, Merck Serono, Merrimack, Merus, Molecular Part. E. van Cutsem: Advisory/Consultancy: Bayer, Lilly, Roche, Servier, BMS, Celegene, MSD, Merck KGaA, Novartis, AstraZeneca, Halozyme, Array BioPharma; Research grant/Funding (institution): Amgen, Bayer, Boehringer Ingelheim, Lilly, Novartis, Roche, Celegene, Ipsen, Merck, Merck KGaA, Servier, BMS. C.S. Fuchs: Advisory/Consultancy: Agios, Amylin Pharmaceuticals, Bain Capital, CytomX Therapeutics, Daiichi-Sankyo, Eli Lilly, Entrinsic Health, Evolveimmune Therapeutics, Genentech, Merck, Taiho, Unum Therapeutics; Leadership role: CytomX Therapeutics (director), Evolveimmune Therapeutics (co-founder); Shareholder/Stockholder/Stock options: CytomX Therapeutics and Entrinsic Health excised options; Evolveimmune Therapeutics. Y.Y. Janjigian: Advisory/Consultancy: Lilly, Pfizer, Merck, Bristol-Myers Squibb, Merck Serono; Research grant/Funding (self): Boehringer Ingelheim, Bayer, Lilly, Amgen, Roche, Genentech. P. Bhagia: Full/Part-time employment: Merck & Co., Inc. K. Li: Full/Part-time employment: Merck & Co., Inc. D. Adelberg: Full/Part-time employment: Merck & Co., Inc. Y-J. Bang: Advisory/Consultancy: AstraZeneca, Novartis, Genentech/Roche, MSD, Merck Serano, Bayer, BMS, Eli Lilly, Taiho, Daiich-Sankyo, Astellas, BeiGene, GreenCross, Samyang Biopharm, Hanmi, Genexine; Research grant/Funding (institution): AstraZeneca, Novartis, Genentech/Roche, MSD, Merck Serano, Bayer, BMS, GSK, Pfizer, Eli Lilly, Boeringer-Ingelheim, MacroGenics, Boston Biomedical, FivePrime, Curis, Taiho, Takeda, Ono, Daiichi Sankyo, Astellas, BeiGene, Green Cross, CKD Pharma, Genexi. All other authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.