Pembrolizumab plus lenalidomide and dexamethasone in treatment-naive multiple myeloma (KEYNOTE-185): subgroup analysis i
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ORIGINAL ARTICLE
Pembrolizumab plus lenalidomide and dexamethasone in treatment‑naive multiple myeloma (KEYNOTE‑185): subgroup analysis in Japanese patients Naoki Takezako1 · Hiroshi Kosugi2 · Morio Matsumoto3 · Shinsuke Iida4 · Takayuki Ishikawa5 · Yukio Kondo6 · Kiyoshi Ando7 · Hirokazu Miki8 · Itaru Matsumura9 · Kazutaka Sunami10 · Takanori Teshima11 · Hiromi Iwasaki12 · Yasushi Onishi13 · Masahiro Kizaki14 · Koji Izutsu15 · Dai Maruyama15 · Kensei Tobinai15 · Razi Ghori16 · Mohammed Farooqui16 · Jason Liao16 · Patricia Marinello16 · Kenji Matsuda17 · Yasuhiro Koh17 · Takashi Shimamoto17 · Kenshi Suzuki18 Received: 27 February 2020 / Revised: 30 June 2020 / Accepted: 14 July 2020 © Japanese Society of Hematology 2020
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 treatmentnaive, 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. Keywords Multiple myeloma · Pembrolizumab · Lenalidomide · Dexamethasone · Japan Electronic supplementary material The online version of this article (https://doi.org/10.1007/s12185-020-02953-3) contains supplementary material, which is available to authorized users. * Naoki Takezako [email protected] 1
National Hospital Organization Disaster Medical Center, 3256 Midori, Tachikawa, Tokyo, Japan
2
Ogaki Municipal Hospital, Ogaki, Japan
3
National Hospital Organization, Shibukawa Medical Center, Shibukawa, Japan
4
Nagoya City University Hospital, Nagoya, Japan
5
Kobe City Medical Center, Kobe, Japan
6
7
Kanazawa University Hospital, Kanazawa, Japan Tokai University School of Medicine, Isehara, Japan
8
Tokushima University Hospital, Tokushima, Japan
9
Kindai University Hospital, Osaka‑Sayama, Japan
10
National Hospital Organization Okayama Medical Center, Okayama, Japan
11
Hokkaido University
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