KEYNOTE-859: A phase III study of pembrolizumab plus chemotherapy in gastric/gastroesophageal junction adenocarcinoma Journal Article
| Authors: | Tabernero, J.; Bang, Y. J.; Van Cutsem, E.; Fuchs, C. S.; Janjigian, Y. Y.; Bhagia, P.; Li, K.; Adelberg, D.; Qin, S. K. |
| Article Title: | KEYNOTE-859: A phase III study of pembrolizumab plus chemotherapy in gastric/gastroesophageal junction adenocarcinoma |
| Abstract: | Current guidelines recommend two-drug cytotoxic chemotherapy with a fluoropyrimidine (fluorouracil or capecitabine) and a platinum-based agent (oxaliplatin or cisplatin) as first-line treatment for advanced gastric cancer. Pembrolizumab monotherapy has demonstrated durable antitumor activity in patients with advanced programmed death ligand 1-positive (combined positive score ≥1) gastric/gastroesophageal junction adenocarcinoma. Accumulating evidence indicates that combining pembrolizumab with standard-of-care chemotherapy for the treatment of advanced or metastatic cancer improves clinical outcomes. We describe the rationale for and the design of the randomized, double-blind, placebo-controlled, Phase III KEYNOTE-859 study, which is investigating pembrolizumab in combination with chemotherapy as first-line treatment for patients with human epidermal growth factor receptor 2-negative advanced unresectable or metastatic gastric/gastroesophageal junction adenocarcinoma. The planned sample size is 1542 patients, and the primary end point is overall survival. Clinical trial registration: NCT03675737 (ClinicalTrials.gov)</ext-link. © 2021 Merck Sharp and Dohme Corp., a subsidiary of Merck and Co., Inc., Kenilworth, NJ, USA. |
| Keywords: | treatment outcome; overall survival; cisplatin; fluorouracil; placebo; drug safety; capecitabine; chemotherapy; outcome assessment; methodology; adenocarcinoma; multiple cycle treatment; epidermal growth factor receptor 2; practice guideline; antineoplastic activity; continuous infusion; europe; immunotherapy; australia; israel; asia; oxaliplatin; esophageal adenocarcinoma; stomach adenocarcinoma; north america; first-line therapy; sample size; gastric cancer; programmed death 1 ligand 1; randomized controlled trial (topic); phase 3 clinical trial (topic); gastroesophageal junction adenocarcinoma; gastroesophageal junction cancer; multicenter study (topic); human; article; pembrolizumab; her2-negative |
| Journal Title: | Future Oncology |
| Volume: | 17 |
| Issue: | 22 |
| ISSN: | 1479-6694 |
| Publisher: | Future Medicine |
| Date Published: | 2021-08-01 |
| Start Page: | 2847 |
| End Page: | 2855 |
| Language: | English |
| DOI: | 10.2217/fon-2021-0176 |
| PUBMED: | 33975465 |
| PROVIDER: | scopus |
| PMCID: | PMC9892960 |
| DOI/URL: | |
| Notes: | Article -- Export Date: 1 September 2021 -- Source: Scopus |
