Ontology highlight
ABSTRACT: Purpose
Pembrolizumab demonstrated antitumor activity in programmed death ligand 1 positive (combined positive score (CPS) ≥ 1) gastric/gastroesophageal junction cancer in KEYNOTE-059 (third line or beyond), KEYNOTE-061 (second line), and KEYNOTE-062 (first line). We characterized efficacy and safety of pembrolizumab monotherapy in Japanese patients across several lines of therapy in these studies.Methods
This analysis was conducted in 34 patients from KEYNOTE-059 cohort 1 (all pembrolizumab), including 13 patients with CPS ≥ 1, 65 patients with CPS ≥ 1 from KEYNOTE-061 (pembrolizumab, n = 27; chemotherapy, n = 38), and 70 patients with CPS ≥ 1 from KEYNOTE-062 (pembrolizumab, n = 38; chemotherapy, n = 32). Overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and safety were evaluated.Results
In KEYNOTE-059, ORR with pembrolizumab was 9%, median PFS was 2 months, and median OS was 10 months. In KEYNOTE-061, median OS was 12 months with pembrolizumab versus 10 months with chemotherapy (hazard ratio (HR), 0.67; 95% confidence interval (CI), 0.39-1.15). Median PFS (pembrolizumab vs. chemotherapy) was 2 months versus 4 months (HR, 1.21; 95% CI, 0.69-2.13); ORR was 7% versus 18%. In KEYNOTE-062, median OS was 20 months with pembrolizumab versus 18 months with chemotherapy (HR, 0.76; 95% CI, 0.43-1.33). Median PFS (pembrolizumab vs. chemotherapy) was 6 months versus 7 months (HR, 1.03; 95% CI, 0.61-1.74); ORR was 29% versus 34%.Conclusions
The current analysis provides valuable information that anti-PD-1 therapies are worthy of further assessment for gastric cancer.Trial registration
ClinicalTrials.gov: NCT02335411 (KEYNOTE-059), NCT02370498 (KEYNOTE-061), and NCT02494583 (KEYNOTE-062).
SUBMITTER: Muro K
PROVIDER: S-EPMC10613141 | biostudies-literature | 2023 Sep
REPOSITORIES: biostudies-literature
Muro Kei K Shitara Kohei K Yamaguchi Kensei K Yoshikawa Takaki T Satake Hironaga H Hara Hiroki H Sugimoto Naotoshi N Machida Nozomu N Goto Masahiro M Kawakami Hisato H Amagai Kenji K Omuro Yasushi Y Esaki Taito T Hironaka Shuichi S Nishina Tomohiro T Komatsu Yoshito Y Matsubara Hisahiro H Shiratori Shinichi S Han Shirong S Satoh Taroh T Ohtsu Atsushi A
Journal of gastrointestinal cancer 20230410 3
<h4>Purpose</h4>Pembrolizumab demonstrated antitumor activity in programmed death ligand 1 positive (combined positive score (CPS) ≥ 1) gastric/gastroesophageal junction cancer in KEYNOTE-059 (third line or beyond), KEYNOTE-061 (second line), and KEYNOTE-062 (first line). We characterized efficacy and safety of pembrolizumab monotherapy in Japanese patients across several lines of therapy in these studies.<h4>Methods</h4>This analysis was conducted in 34 patients from KEYNOTE-059 cohort 1 (all p ...[more]