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 language | English |
---|---|
Pages (from-to) | 640-649 |
Number of pages | 10 |
Journal | International journal of hematology |
Volume | 112 |
Issue number | 5 |
DOIs | |
Publication status | Published - 2020 Nov 1 |
Keywords
- Dexamethasone
- Japan
- Lenalidomide
- Multiple myeloma
- Pembrolizumab
ASJC Scopus subject areas
- Hematology
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Pembrolizumab plus lenalidomide and dexamethasone in treatment-naive multiple myeloma (KEYNOTE-185) : subgroup analysis in Japanese patients. / Takezako, Naoki; Kosugi, Hiroshi; Matsumoto, Morio; Iida, Shinsuke; Ishikawa, Takayuki; Kondo, Yukio; Ando, Kiyoshi; Miki, Hirokazu; Matsumura, Itaru; Sunami, Kazutaka; Teshima, Takanori; Iwasaki, Hiromi; Onishi, Yasushi; Kizaki, Masahiro; Izutsu, Koji; Maruyama, Dai; Tobinai, Kensei; Ghori, Razi; Farooqui, Mohammed; Liao, Jason; Marinello, Patricia; Matsuda, Kenji; Koh, Yasuhiro; Shimamoto, Takashi; Suzuki, Kenshi.
In: International journal of hematology, Vol. 112, No. 5, 01.11.2020, p. 640-649.Research output: Contribution to journal › Article › peer-review
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TY - JOUR
T1 - Pembrolizumab plus lenalidomide and dexamethasone in treatment-naive multiple myeloma (KEYNOTE-185)
T2 - subgroup analysis in Japanese patients
AU - Takezako, Naoki
AU - Kosugi, Hiroshi
AU - Matsumoto, Morio
AU - Iida, Shinsuke
AU - Ishikawa, Takayuki
AU - Kondo, Yukio
AU - Ando, Kiyoshi
AU - Miki, Hirokazu
AU - Matsumura, Itaru
AU - Sunami, Kazutaka
AU - Teshima, Takanori
AU - Iwasaki, Hiromi
AU - Onishi, Yasushi
AU - Kizaki, Masahiro
AU - Izutsu, Koji
AU - Maruyama, Dai
AU - Tobinai, Kensei
AU - Ghori, Razi
AU - Farooqui, Mohammed
AU - Liao, Jason
AU - Marinello, Patricia
AU - Matsuda, Kenji
AU - Koh, Yasuhiro
AU - Shimamoto, Takashi
AU - Suzuki, Kenshi
N1 - Funding Information: Naoki Takezako: no conflicts to disclose. Hiroshi Kosugi: Honoraria: Chugai Pharmaceutical, Celgene KK, Novartis. Pharmaceuticals, Merck, Takeda, Janssen, Japan Blood Projects Organization, Bristol-Myers-Squibb, Ono Pharmaceutical. Morio Matsumoto: personal fees from Celgene Co., LTD, Janssen Pharmaceutical Co., LTD, Bristol-Myers Squibb K.K., Ono Pharmaceuticals, Co., LTD. Shinsuke Iida: grant from Merck (submitted work); Grants (outside of submitted work) Celgene, Janssen, Ono Pharmaceuticals, Takeda, Bristol-Myers Squibb, Novartis, Daiichi Sanjyo, Chugai, Kyowa Kirin, Abbvie, Gilead, and Sanofi; Personal Fees: Celgene, Janssen, Ono Pharmaceuticals, Takeda, Bristol-Myers Squibb, Novartis and Daiichi Sankyo. Takayuki Ishikawa: no conflicts to disclose. Yukio Kondo: no conflicts to disclose. Kiyoshi Ando: research funding from Eisai Co., Kyowa Kirin Co., Ltd, Chugai, Pharmaceutical Co., Ltd., Takeda Pharmaceutical Company Limited, Meiji Seika Pharma Co., Ltd. Hirokazu Miki: no conflicts to disclose. Itaru Matsumara: grants from Celgene Co., Ltd, and personal fees from Celgene Ltd, Novartis Pharmaceuticals, K.K., and Bristol Myers Squibb. Kazutaka Sunami: research funding from Merck during the conduct of the study and research funding from Novartis, GlaxoSmithKline, Janssen Pharmaceutical, Abbvie, Takeda Pharmaceutical, Sanofi, Bristol-Myers Squibb, Ono Pharmaceutical Alexion Pharmaceutical, Daiichi Sankyo and Celgene; honoraria from Takeda Pharmaceutical, Bristol-Myers Squibb, Ono Pharmaceutical and Celgene. Takanori Teshima: research funding from Kyowa Kirin, Novartis Pharmaceuticals K. K., Chugai Pharmaceuticals, Sanofi K. K., Astellas Pharmaceuticals, Inc., Teijin pharma limited, Fuji pharma Co., Ltd, Nippon Shinyaku, Co., Ltd., Japan Society for the Promotion of Science (KAKENHI 17H04206) and The Center of Innovation Program from Japan Science and Technology Agency; honoraria from Merck, Kyowa Kirin, Takeda Pharmaceuticals, Novartis Pharmaceuticals K. K., Pfizer Japan, Inc., Bristol Myers Squibb; manuscript preparation from Janssen Pharmaceuticals K. K. Hiromi Iwasaki: no conflicts to disclose. Yasushi Onishi: personal fees from Pfizer, Astellas, Chugai, Novartis, Bristol-Myers Squibb, Celgene, Sumitomo Dainippon, Ono Pharmaceuticals, Nippon Shinyaku, Janssen, Otsuka, Kyowa Kirin, and Merck; Research funding from Takeda, Bristol-Myers Squibb, and Merck. Masahiro Kizaki: no conflicts to disclose. Koji Izutsu: Dr. Izutsu reports grants from Merck, during the conduct of the study; grants from Eisai, Takeda, Janssen, Mundipharma, Chugai, AstraZeneca, Abbvie, Bayer, Ono Pharmaceuticals, Gilead, Zenyaku, Celgene, Solasia, Symbio, Astellas, Astellas Amgen, Bayer, Daiichi Sankyo; personal fees, from Eisai, Merck, Takeda, Janssen, Bristol Myers Squibb, Dainihon Sumitomo Mundipharma, Nihon Mediphysics, Chugai, AstraZeneca, Abbvie, Bayer, Ono Pharmaceuticals, Celgene, Kyowa Kirin. Dai Maruyama: research funding from Ono Pharmaceutical, Celgene, Takeda Pharmaceutical, Janssen Pharmaceutical, Chugai Pharmaceutical, Bristol-Myers Squibb, Merck, Amgen Astellas Biopharma, Astellas Pharma, Sanofi, Novartis Pharmaceuticals, and Otsuka Pharmaceutical. Personal fees from, Eisai, Kyowa Hakko Kirin, Zenyaku Kogyo Synmosa Biopharma, Nippon Shinyaku. Kensei Tobinai: grants from Eisai, Takeda, Mundipharma, Kyowa Kirin, Celgene, Chugai Pharmaceuticals, Ono Pharmaceuticals, Janssen and Abbvie; Personal Fees from Eisai, Takeda, Mundipharma, HUYA Bioscience International, Kyowa Kirin, Celgene, Chugai Pharmaceuticals, Ono Pharmaceuticals, Yakult, Daiichi Sankyo, Bristol-Myers Squibb, Meiji Seika Kaisha, Solasis Pharmaceuticals, and Verastem. Razi Ghori: employee of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Mohammed Farooqui: employee of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA and a stockholder of Merck & Co., Inc, Kenilworth, NJ, USA. Jason Liao: employee of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Patricia Marinello: employee of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA and a stockholder of Merck & Co., Inc., Kenilworth, NJ, USA; travel expenses from Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Kenji Matsuda: employee of MSD K.K, Tokyo, Japan, and a stockholder of Merck & Co., Inc., Kenilworth, NJ, USA. Yasuhiro Koh: employee of MSD K.K, Tokyo, Japan. Takashi Shimamoto: employee of MSD K.K, Tokyo, Japan and a stockholder of Merck & Co., Inc., Kenilworth, NJ, USA. Kenshi Suzuki: honoraria from Celgene, Takeda, Ono Pharmaceuticals, Amgen, Novartis, Sanofi, Bristol-Myers Squibb, Abie and Janssen; Consultancy from Amgen, Janssen, Takeda, and Celgene and research funding from Bristol-Myers Squibb, Celgene, and Amgen. Acknowledgements Funding Information: The authors thank the patients and their families and caregivers for contributing to this study. The authors also acknowledge the investigators, site personnel, and personnel of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, who supported this study. Medical writing and/or editorial assistance was provided by Julia Burke, PhD, and Matthew Grzywacz, PhD, of the ApotheCom pembrolizumab team (Yardley, PA, USA). This assistance was funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Funding for this research was provided by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Funding Information: The authors thank the patients and their families and caregivers for contributing to this study. The authors also acknowledge the investigators, site personnel, and personnel of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, who supported this study. Medical writing and/or editorial assistance was provided by Julia Burke, PhD, and Matthew Grzywacz, PhD, of the ApotheCom pembrolizumab team (Yardley, PA, USA). This assistance was funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Funding for this research was provided by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Publisher Copyright: © 2020, Japanese Society of Hematology.
PY - 2020/11/1
Y1 - 2020/11/1
N2 - 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.
AB - 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.
KW - Dexamethasone
KW - Japan
KW - Lenalidomide
KW - Multiple myeloma
KW - Pembrolizumab
UR - http://www.scopus.com/inward/record.url?scp=85091162197&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85091162197&partnerID=8YFLogxK
U2 - 10.1007/s12185-020-02953-3
DO - 10.1007/s12185-020-02953-3
M3 - Article
C2 - 32949374
AN - SCOPUS:85091162197
VL - 112
SP - 640
EP - 649
JO - International Journal of Hematology
JF - International Journal of Hematology
SN - 0925-5710
IS - 5
ER -