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Background <p>In the global phase 3 KEYNOTE-859 study (NCT03675737), first-line pembrolizumab plus chemotherapy significantly improved overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) versus placebo plus chemotherapy in participants with advanced human epidermal growth factor receptor 2 (HER2)–negative gastric or gastroesophageal junction (GEJ) adenocarcinoma. This post hoc analysis of KEYNOTE-859 evaluated outcomes in participants enrolled in Japan.</p> Methods <p>Participants with untreated locally advanced unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma were randomly assigned to receive pembrolizumab 200&#xa0;mg or placebo intravenously every 3&#xa0;weeks for ≤ 35 cycles plus investigator’s choice of chemotherapy. The primary end point was OS. Secondary end points were ORR, DOR, and PFS per RECIST v1.1, by blinded independent central review, and safety. Data cutoff was October 3, 2022.</p> Results <p>Overall, 101 participants were enrolled in Japan (<i>n</i> = 48 pembrolizumab plus chemotherapy [pembrolizumab group]; <i>n</i> = 53 placebo plus chemotherapy [placebo group]). Median follow-up was 28.9&#xa0;months (range, 22.0–42.0). Median OS was 16.8&#xa0;months with pembrolizumab versus 13.3&#xa0;months with placebo (hazard ratio [HR], 0.71; 95% CI, 0.44–1.13). Grade 3 or 4 treatment-related adverse events occurred in 41.7% of participants given pembrolizumab and 39.6% of participants given placebo; none were grade 5.</p> Conclusions <p>Consistent with the global KEYNOTE-859 results, OS was better with pembrolizumab plus chemotherapy, with manageable safety, for participants enrolled in Japan. Results continue to support pembrolizumab plus chemotherapy as a new first-line treatment option for patients with advanced or metastatic HER2-negative gastric or GEJ adenocarcinoma.</p> Trial Registration <p>ClinicalTrials.gov, NCT03675737.</p>

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First-line pembrolizumab plus chemotherapy for participants in Japan with gastric or gastroesophageal junction adenocarcinoma: subgroup analysis of the phase 3 KEYNOTE-859 study

  • 期刊论文

  • 发表日期：

    2025年8月1日

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  • Hisateru Yasui,
  • Masaki Aizawa,
  • Kensei Yamaguchi,
  • Akihito Kawazoe,
  • Hiroki Hara,
  • Masahiro Tsuda,
  • Hirokazu Shoji,
  • Naotoshi Sugimoto,
  • Nobuhiro Shibata,
  • Kenji Amagai,
  • Yasuhiro Choda,
  • Shiro Iwagami,
  • Taito Esaki,
  • Shigenori Kadowaki,
  • Shinichi Shiratori,
  • Shirong Han,
  • Sonal Bordia,
  • Kohei Shitara

摘要

Background

In the global phase 3 KEYNOTE-859 study (NCT03675737), first-line pembrolizumab plus chemotherapy significantly improved overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) versus placebo plus chemotherapy in participants with advanced human epidermal growth factor receptor 2 (HER2)–negative gastric or gastroesophageal junction (GEJ) adenocarcinoma. This post hoc analysis of KEYNOTE-859 evaluated outcomes in participants enrolled in Japan.

Methods

Participants with untreated locally advanced unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma were randomly assigned to receive pembrolizumab 200 mg or placebo intravenously every 3 weeks for ≤ 35 cycles plus investigator’s choice of chemotherapy. The primary end point was OS. Secondary end points were ORR, DOR, and PFS per RECIST v1.1, by blinded independent central review, and safety. Data cutoff was October 3, 2022.

Results

Overall, 101 participants were enrolled in Japan (n = 48 pembrolizumab plus chemotherapy [pembrolizumab group]; n = 53 placebo plus chemotherapy [placebo group]). Median follow-up was 28.9 months (range, 22.0–42.0). Median OS was 16.8 months with pembrolizumab versus 13.3 months with placebo (hazard ratio [HR], 0.71; 95% CI, 0.44–1.13). Grade 3 or 4 treatment-related adverse events occurred in 41.7% of participants given pembrolizumab and 39.6% of participants given placebo; none were grade 5.

Conclusions

Consistent with the global KEYNOTE-859 results, OS was better with pembrolizumab plus chemotherapy, with manageable safety, for participants enrolled in Japan. Results continue to support pembrolizumab plus chemotherapy as a new first-line treatment option for patients with advanced or metastatic HER2-negative gastric or GEJ adenocarcinoma.

Trial Registration

ClinicalTrials.gov, NCT03675737.