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Pembrolizumab plus pomalidomide and dexamethasone for relapsed or refractory multiple myeloma (KEYNOTE-183): subgroup analysis in Japanese patients.
Matsumoto, Morio; Suzuki, Kenshi; Kuroda, Junya; Taniwaki, Masafumi; Sunami, Kazutaka; Kosugi, Hiroshi; Ando, Kiyoshi; Maruyama, Dai; Tobinai, Kensei; Kher, Uma; Farooqui, Mohammed; Liao, Jason; Marinello, Patricia; Matsuda, Kenji; Koh, Yasuhiro; Shimamoto, Takashi; Iida, Shinsuke.
Affiliation
  • Matsumoto M; National Hospital Organization, Shibukawa Medical Center, 383 Shiroi, Shibukawa, 377-0280, Japan. matsumoto.morio.zr@mail.hosp.go.jp.
  • Suzuki K; Japanese Red Cross Medical Center, Tokyo, Japan.
  • Kuroda J; Kyoto Prefectural University of Medicine, Kyoto, Japan.
  • Taniwaki M; Kyoto Prefectural University of Medicine, Kyoto, Japan.
  • Sunami K; National Hospital Organization Okayama Medical Center, Okayama, Japan.
  • Kosugi H; Ogaki Municipal Hospital, Ogaki, Japan.
  • Ando K; Tokai University Hospital, Isehara, Japan.
  • Maruyama D; National Cancer Center Hospital, Tokyo, Japan.
  • Tobinai K; National Cancer Center Hospital, Tokyo, Japan.
  • Kher U; Merck & Co., Inc., Kenilworth, NJ, USA.
  • Farooqui M; Merck & Co., Inc., Kenilworth, NJ, USA.
  • Liao J; Merck & Co., Inc., Kenilworth, NJ, USA.
  • Marinello P; Merck & Co., Inc., Kenilworth, NJ, USA.
  • Matsuda K; MSD K.K., Tokyo, Japan.
  • Koh Y; MSD K.K., Tokyo, Japan.
  • Shimamoto T; MSD K.K., Tokyo, Japan.
  • Iida S; Nagoya City University Hospital, Nagoya, Japan.
Int J Hematol ; 113(6): 777-784, 2021 Jun.
Article in En | MEDLINE | ID: mdl-33856638
The global, randomized, open-label KEYNOTE-183 phase 3 study was closed early after an interim analysis showed unfavorable risk-benefit when pembrolizumab was added to pomalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma (MM). This subgroup analysis reported outcomes in 27 Japanese patients randomly assigned to receive pembrolizumab plus pomalidomide and dexamethasone (n = 15) or pomalidomide and dexamethasone alone (n = 12). Co-primary endpoints were progression-free survival (PFS) and overall survival (OS). After a median (range) follow-up of 9.6 (1.4-15.3) months in Japanese patients, median PFS [6.5 vs 2.8 months; hazard ratio (HR) 0.16 (95% CI 0.03-0.83)] and OS [not reached vs 14.8 months; HR 0.46 (95% CI 0.05-4.20)] seemed to favor the pembrolizumab plus pomalidomide and dexamethasone arm. Objective response rate was numerically higher in this group (47%) than in the pomalidomide and dexamethasone group (25%). The safety profile was consistent with that of the overall study population. No deaths were attributed to a study drug by the investigators. Although adding pembrolizumab to pomalidomide and dexamethasone did not show unfavorable risk-benefit in the Japanese subgroup of KEYNOTE-183, the analysis is limited by short follow-up and small sample size, which affects the generalizability of the results.
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Antineoplastic Combined Chemotherapy Protocols / Multiple Myeloma Type of study: Clinical_trials Limits: Adult / Aged / Female / Humans / Male / Middle aged Country/Region as subject: Asia Language: En Journal: Int J Hematol Journal subject: HEMATOLOGIA Year: 2021 Document type: Article Affiliation country: Country of publication:

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Antineoplastic Combined Chemotherapy Protocols / Multiple Myeloma Type of study: Clinical_trials Limits: Adult / Aged / Female / Humans / Male / Middle aged Country/Region as subject: Asia Language: En Journal: Int J Hematol Journal subject: HEMATOLOGIA Year: 2021 Document type: Article Affiliation country: Country of publication: