Safety and efficacy of pembrolizumab in combination with S-1 plus oxaliplatin as a first-line treatment in patients with advanced gastric/gastroesophageal junction cancer: Cohort 1 data from the KEYNOTE-659 phase IIb study.

European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)
Akihito KawazoeKohei Shitara

Abstract

The KEYNOTE-659 study evaluated the efficacy and safety of pembrolizumab in combination with chemotherapy as the first-line treatment in Japanese patients with advanced gastric/gastroesophageal junction (G/GEJ) cancer. In this paper, we report results from cohort 1 (S-1 plus oxaliplatin [SOX] with pembrolizumab). This was a non-randomised, multicentre, open-label phase IIb study in patients with advanced programmed death-ligand 1 (PD-L1)-positive, human epidermal growth factor receptor 2-negative G/GEJ tumours. The primary endpoint was the objective response rate (ORR) assessed by blinded independent central review (BICR). Secondary endpoints were duration of response (DOR), disease control rate (DCR), time to response (TTR), progression-free survival (PFS), overall survival (OS) and safety. Exploratory analyses were performed based on the PD-L1 combined positive score (CPS) status. Fifty-four patients were evaluated. The median follow-up was 10.1 months. ORR and DCR by BICR were 72.2% (95% confidence interval [CI] 58.4-83.5) and 96.3% (95% CI 87.3-99.5), respectively. Median DOR, TTR, PFS and OS were as follows: not reached, 1.5 months, 9.4 months and not reached. The ORR was 73.9% in patients with CPS ≥1 to <10 and 71.0% in t...Continue Reading

Citations

Oct 25, 2020·Virchows Archiv : an International Journal of Pathology·Marina Alessandra PereiraTiago Biachi de Castria
Nov 27, 2020·Japanese Journal of Clinical Oncology·Akihito KawazoeMasanori Terashima
Nov 13, 2020·Gastric Cancer : Official Journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association·Toshifumi YamaguchiNarikazu Boku
Mar 6, 2021·Cancer Gene Therapy·Matthew J Olnes, Holly A Martinson
Mar 27, 2021·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Zhi PengLin Shen
Aug 10, 2020·Biomedicine & Pharmacotherapy = Biomédecine & Pharmacothérapie·Jiangang SunYongshun Gao
Aug 10, 2021·World Journal of Clinical Cases·Chao LiangWei Chen
Jul 14, 2021·Journal of Surgical Oncology·Marina Alessandra PereiraEvandro Sobroza de Mello

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