Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Sanofi, Cambridge, Massachusetts, USA.
Cancer Med. 2023 Apr;12(7):8005-8017. doi: 10.1002/cam4.5584. Epub 2023 Feb 1.
Lenalidomide-based regimens are commonly used for early relapse in patients with relapsed and/or refractory multiple myeloma (RRMM) receiving at least one prior line of therapy. In the absence of head-to-head comparison, matching-adjusted indirect comparison (MAIC) was conducted to demonstrate efficacy and safety of isatuximab+carfilzomib+dexamethasone (Isa-Kd) versus daratumumab + lenalidomide + dexamethasone (Dara-Rd) in RRMM.
Patient-level data from IKEMA trial (Isa-Kd, n = 179) were matched to aggregate data from POLLUX (Dara-Rd, n = 286). Hazard ratios (HR) and 95% confidence intervals (CI) for progression-free survival (PFS) and overall survival (OS) were generated by weighted Cox proportional hazard models. Odds ratios (OR), 95% CI, and p-value were calculated for ≥very good partial response (≥VGPR) and treatment-emergent adverse events (TEAEs).
After matching, no significant differences were observed between Isa-Kd and Dara-Rd in baseline characteristics except for patients with >3 prior lines (0.0% vs. 4.9%). Isa-Kd showed significantly better PFS (HR [95% CI]: 0.46 [0.24-0.86]; p = 0.0155), statistically non-significant improvement favoring Isa-Kd in OS (0.47 [0.20-1.09]; 0.0798), and ≥VGPR (OR [95% CI]: 1.53 [0.89-2.64]; p = 0.1252) than Dara-Rd. Odds of occurrence were significantly lower for some all-grade and grade 3/4 TEAEs with Isa-Kd than Dara-Rd.
These results support Isa-Kd as an efficacious treatment for early relapse in non-lenalidomide refractory patients.
在接受至少一线治疗的复发/难治性多发性骨髓瘤(RRMM)患者中,基于来那度胺的方案常用于早期复发。在没有头对头比较的情况下,采用匹配调整间接比较(MAIC)来证明伊沙佐米+卡非佐米+地塞米松(Isa-Kd)与达雷妥尤单抗+来那度胺+地塞米松(Dara-Rd)在 RRMM 中的疗效和安全性。
从 IKEMA 试验(Isa-Kd,n=179)的患者水平数据中进行匹配,汇总来自 POLLUX(Dara-Rd,n=286)的数据。通过加权 Cox 比例风险模型生成无进展生存期(PFS)和总生存期(OS)的风险比(HR)和 95%置信区间(CI)。计算≥非常好的部分缓解(≥VGPR)和治疗中出现的不良事件(TEAEs)的比值比(OR)、95%CI 和 p 值。
匹配后,除了有>3 条既往治疗线的患者(0.0%对 4.9%)外,Isa-Kd 和 Dara-Rd 在基线特征方面没有显著差异。Isa-Kd 表现出显著更好的 PFS(HR [95%CI]:0.46 [0.24-0.86];p=0.0155),OS 方面有统计学上非显著的获益倾向于 Isa-Kd(0.47 [0.20-1.09];0.0798),以及≥VGPR(OR [95%CI]:1.53 [0.89-2.64];p=0.1252)。与 Dara-Rd 相比,Isa-Kd 发生某些全级和 3/4 级 TEAEs 的可能性显著降低。
这些结果支持 Isa-Kd 作为非来那度胺难治性患者早期复发的有效治疗方法。