Efficacy of pembrolizumab monotherapy for advanced gastric/gastroesophageal junction cancer with programmed death ligand 1 combined positive score ≥10

Zev A. Wainberg, Charles S. Fuchs, Josep Tabernero, Kohei Shitara, Kei Muro, Eric Van Cutsem, Yung Jue Bang, Hyun Cheol Chung, Kensei Yamaguchi, Eniko Varga, Jen Shi Chen, Daniel Hochhauser, Peter Thuss-Patience, Salah Eddin Al-Batran, Marcelo Garrido, Uma Kher, Chie Schin Shih, Sukrut Shah, Pooja Bhagia, Joseph Chao

Research output: Contribution to journalArticlepeer-review

2 Citations (Scopus)

Abstract

Purpose: Pembrolizumab demonstrated efficacy in PD-L1-positive [combined positive score (CPS) ≥1] advanced gastric/gastroesophageal junction (G/GEJ) cancer in the first-, second-, and thirdline setting in KEYNOTE-062, KEYNOTE-061, and KEYNOTE- 059, respectively. To better delineate the specificity of CPS as a predictor of clinical outcomes, we analyzed pembrolizumab efficacy in patients with CPS ≥ 10 in these trials. Patients and Methods: Included were patients with CPS ≥ 10 tumors from KEYNOTE-059 cohort 1 (pembrolizumab, n = 46; post hoc), KEYNOTE-061 (pembrolizumab, n= 53; chemotherapy, n = 55; post hoc), and KEYNOTE-062 (pembrolizumab, n = 92; chemotherapy, n = 90; primary). Efficacy outcomes were overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and duration of response (DOR). Results: In KEYNOTE-059, median follow-up was 6 months, median OS was 8 months [95% confidence interval (CI), 5.8-11.1], ORR was 17%, and median (range) DOR was 21 months (3+ to 35+). In KEYNOTE-061, median follow-up was 9 months, median OS (pembrolizumab vs. chemotherapy) was 10 versus 8 months (HR, 0.64; 95% CI, 0.41-1.02), median PFS was 3 months versus 3 months (HR, 0.86; 95% CI, 0.56-1.33), ORR was 25% versus 9%, and median (range)DORwas not reached (4 to 26+months) versus 7 months (3-7). In KEYNOTE-062, median follow-up was 11 months, median OS (pembrolizumab vs. chemotherapy) was 17 months versus 11 months (HR, 0.69; 95% CI, 0.49-0.97), median PFS was 3 months versus 6 months (HR, 1.09, 95% CI; 0.79-1.49), ORR was 25% versus 38%, and median (range) DOR was 19 months (1+ to 34+) versus 7 months (2+ to 30+). Conclusions: This comprehensive analysis showed consistent improvements toward more favorable clinical outcomes with pembrolizumab across lines of therapy in patients with CPS ≥ 10 G/GEJ cancer.

Original languageEnglish
Pages (from-to)1923-1931
Number of pages9
JournalClinical Cancer Research
Volume27
Issue number7
DOIs
Publication statusPublished - 2021 Apr

Bibliographical note

Funding Information:
The authors thank the patients and their families and all investigators and site personnel. The authors also thank Eric Rubin of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ. Medical writing and/or editorial assistance was provided by Holly C. Cappelli, PhD, CMPP, and Brian Szente, PhD, of ApotheCom (Yardley, PA). This assistance was funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ.

Publisher Copyright:
© 2021 American Association for Cancer Research.

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

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