Pembrolizumab plus lenalidomide and dexamethasone in treatment-naive multiple myeloma (KEYNOTE-185): subgroup analysis in Japanese patients
Pembrolizumab plus lenalidomide and dexamethasone in treatment-naive multiple myeloma (KEYNOTE-185): subgroup analysis in Japanese patients
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DOI：
10.1007/s12185-020-02953-3
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发表时间：
2020-09-19
影响因子：
2.1
通讯作者：
Suzuki, Kenshi
中科院分区：
文献类型：
--
作者：
Takezako, Naoki;Kosugi, Hiroshi;Suzuki, Kenshi
全球、随机、开放标签的KEYNOTE-185研究在中期分析后提前关闭，显示帕博利珠单抗联合来那度胺和低剂量地塞米松（Rd）与单独Rd治疗初治、不适合移植的多发性骨髓瘤相比，获益-风险特征不利。该亚组分析报告了日本人群的结局。患者被随机分配（1：1）至帕博利珠单抗+Rd或Rd单药组，按年龄和国际分期系统分层。主要终点是无进展生存期（PFS）。52例日本患者被随机分配至派姆单抗+Rd组（n = 27）或Rd组（n = 25）。中位随访时间为7.2个月（范围：0.4-13.8）。未达到中位PFS（NR）; 6个月PFS为91.2%，帕博利珠单抗+Rd组为86.2%，Rd组为86.2%[风险比（HR），0.31; 95% CI，0.06-1.63]。中位总生存期（OS）为NR; 6个月OS为96.2%，帕博利珠单抗加Rd组与Rd组的OS为95.7%（HR，0.33; 95%CI，0.03-3.72）。帕博利珠单抗+Rd与Rd相比，70.4%与69.6%的患者发生3-5级不良事件; 40.7%与52.5%的患者发生严重不良事件。尽管在KEYNOTE-185的日本亚组中，在Rd基础上添加帕博利珠单抗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，影响了结果的普遍性。
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.