National Hospital Organization, Shibukawa Medical Center, 383 Shiroi, Shibukawa, 377-0280, Japan.
Japanese Red Cross Medical Center, Tokyo, Japan.
Int J Hematol. 2021 Jun;113(6):777-784. doi: 10.1007/s12185-021-03139-1. Epub 2021 Apr 15.
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.
这项全球、随机、开放性 KEYNOTE-183 三期研究在中期分析显示 pembrolizumab 联合泊马度胺和地塞米松治疗复发性或难治性多发性骨髓瘤（MM）患者的风险获益不利后提前终止。本亚组分析报告了 27 例随机分配接受 pembrolizumab 联合泊马度胺和地塞米松（n=15）或泊马度胺和地塞米松单药治疗（n=12）的日本患者的结局。主要终点为无进展生存期（PFS）和总生存期（OS）。在日本患者的中位（范围）随访 9.6（1.4-15.3）个月后，中位 PFS [6.5 比 2.8 个月；风险比（HR）0.16（95%CI 0.03-0.83)] 和 OS [未达到比 14.8 个月；HR 0.46（95%CI 0.05-4.20)] 似乎有利于 pembrolizumab 联合泊马度胺和地塞米松组。该组的客观缓解率（ORR）（47%）高于泊马度胺和地塞米松组（25%）。安全性特征与总体研究人群一致。研究者未将任何死亡归因于研究药物。尽管在 KEYNOTE-183 的日本亚组中，pembrolizumab 联合泊马度胺和地塞米松并未显示出不利的风险获益，但该分析受到随访时间短和样本量小的限制，这影响了结果的普遍性。
