Pembrolizumab with or without chemotherapy versus chemotherapy alone for patients with PD-L1–positive advanced gastric or gastroesophageal junction adenocarcinoma: Update from the phase 3 KEYNOTE-062 trial.

作者：Zev A. Wainberg, Kohei Shitara, Eric Van Cutsem, Lucjan Wyrwicz, Keun Wook Lee, Iveta Kudaba, Marcelo Garrido, Hyun Cheol Chung, Jeeyun Lee, Hugo Castro‐Salguero, Wasat Mansoor, Maria Ignez Braghiroli, Nina Karaseva, Eray Goekkurt, Hironaga Satake, Joseph Chao, Uma Kher, Sukrut Shah, Pooja Bhagia, Josep Tabernero · 发表于：Journal of Clinical Oncology · 年份：2022 · DOI：10.1200/jco.2022.40.4_suppl.243 · 被引用次数：24 · 研究领域：Gastric Cancer Management and Outcomes、Gastrointestinal Tumor Research and Treatment、Cancer Immunotherapy and Biomarkers

243 Background: KEYNOTE-062 (NCT02494583) is a global phase 3 study of pembrolizumab (pembro) as monotherapy and in combination with chemotherapy (chemo) versus chemo as first-line therapy for PD-L1–positive (combined positive score [CPS] ≥1) advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. At the time of the protocol-specified final analysis, pembro was noninferior to chemo, with fewer adverse events (AEs) observed. Pembro or pembro + chemo was not superior to chemo for the overall survival (OS) and progression-free survival (PFS) end points tested. We present the results of KEYNOTE-062 after ̃25 additional months of follow-up (cutoff: April 19, 2021). Methods: Patients with previously untreated gastric or GEJ cancer were randomly assigned 1:1:1 to pembro 200 mg Q3W, pembro + chemo (cisplatin 80 mg/m 2 /day on day 1 + 5-FU 800 mg/m 2 /day on days 1-5 Q3W [or capecitabine 1000 mg/m 2 twice daily on days 1-14 Q3W per local guidelines]), or placebo Q3W + chemo. Primary end points were OS in the CPS ≥1 and CPS ≥10 populations for pembro + chemo versus chemo and pembro versus chemo and PFS (RECIST v1.1; central review) in the CPS ≥1 and CPS ≥10 populations for pembro + chemo versus chemo. Safety was also evaluated. Results: At the time of data cutoff, 689 of 763 patients (90.3%) had died. Median follow-up (defined as time from randomization to data cutoff) was 54.3 months (range, 46.8-66.1). Pembro was noninferior to chemo for OS in the CPS ≥1 population (media...