Pembrolizumab plus lenalidomide and dexamethasone in treatment-naive multiple myeloma (KEYNOTE-185): subgroup analysis in Japanese patients

Naoki Takezako, Hiroshi Kosugi, Morio Matsumoto, Shinsuke Iida, Takayuki Ishikawa, Yukio Kondo, Kiyoshi Ando, Hirokazu Miki, Itaru Matsumura, Kazutaka Sunami, Takanori Teshima, Hiromi Iwasaki, Yasushi Onishi, Masahiro Kizaki, Koji Izutsu, Dai Maruyama, Kensei Tobinai, Razi Ghori, Mohammed Farooqui, Jason LiaoPatricia Marinello, Kenji Matsuda, Yasuhiro Koh, Takashi Shimamoto, Kenshi Suzuki

Research output: Contribution to journalArticlepeer-review

1 Citation (Scopus)

Abstract

The global, randomized, open-label KEYNOTE-185 study closed early after an interim analysis showed an unfavorable benefit-risk profile with pembrolizumab plus lenalidomide and low-dose dexamethasone (Rd) versus Rd alone in treatment-naive, transplant-ineligible multiple myeloma. This subgroup analysis reported outcomes in the Japanese population. Patients were randomly assigned (1:1) to pembrolizumab plus Rd or Rd alone, stratified by age and International Staging System. The primary end point was progression-free survival (PFS). Fifty-two Japanese patients were randomly assigned to pembrolizumab plus Rd (n = 27) or Rd (n = 25). The median follow-up was 7.2 months (range, 0.4–13.8). The median PFS was not reached (NR); 6-month PFS was 91.2% versus 86.2% with pembrolizumab plus Rd versus Rd [hazard ratio (HR), 0.31; 95% CI, 0.06–1.63]. The median overall survival (OS) was NR; 6-month OS was 96.2% versus 95.7% with pembrolizumab plus Rd versus Rd (HR, 0.33; 95% CI, 0.03–3.72). With pembrolizumab plus Rd versus Rd, grade 3–5 adverse events occurred in 70.4% versus 69.6% of patients; serious adverse events occurred in 40.7% versus 52.5%. Although in the Japanese subgroup of KEYNOTE-185 adding pembrolizumab to Rd did not show an unfavorable risk-benefit, the analysis is limited by short follow-up and small sample size, affecting generalizability of the results.

Original languageEnglish
Pages (from-to)640-649
Number of pages10
JournalInternational journal of hematology
Volume112
Issue number5
DOIs
Publication statusPublished - 2020 Nov 1

Keywords

  • Dexamethasone
  • Japan
  • Lenalidomide
  • Multiple myeloma
  • Pembrolizumab

ASJC Scopus subject areas

  • Hematology

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