Longer-term outcomes with the anti-CD38 antibody isatuximab in combination with carfilzomib-dexamethasone (Isa-Kd) were evaluated in the randomized Phase 3 trial IKEMA (NCT03275285), in a prespecified, follow-up analysis of progression-free survival (PFS, primary study endpoint), final complete response (CR) using Hydrashift Isa immunofixation assay, minimal residual disease (MRD) negativity, and safety. Enrolled patients had relapsed/refractory multiple myeloma (1–3 prior treatment lines). Isa 10 mg/kg was administered intravenously weekly in cycle 1 then biweekly. Efficacy analyses were performed in the intent-to-treat population (Isa-Kd: n = 179, Kd: n = 123) and safety evaluated in treated patients (Isa-Kd: n = 177, Kd: n = 122). Consistent with the primary interim analysis, the addition of Isa to Kd prolonged PFS (HR 0.58, 95.4% CI: 0.42–0.79; median PFS 35.7 [95% CI: 25.8–44.0] vs 19.2 [95% CI: 15.8–25.0] months). PFS benefit was observed with Isa-Kd across subgroups, including patients with poor prognosis. The stringent CR/CR rate was 44.1% vs 28.5% (odds-ratio: 2.09, 95% CI: 1.26–3.48), the MRD negativity rate 33.5% vs 15.4% (odds-ratio: 2.78, 95% CI: 1.55–4.99) and the MRD negativity CR rate 26.3% vs 12.2%, with Isa-Kd vs Kd. The safety profile of Isa-Kd was similar to that reported in the prior interim analysis. These findings further support Isa-Kd as a standard-of-care treatment for relapsed multiple myeloma patients. Clinical trial information: ClinicalTrials.gov, NCT03275285.
在随机3期试验IKEMA（NCT03275285）中，通过一项预设的无进展生存期（PFS，主要研究终点）随访分析、采用Hydrashift伊沙免疫固定检测的最终完全缓解率、微小残留病阴性率及安全性评估，考察了抗CD38抗体伊沙妥昔单抗联合卡非佐米-地塞米松的长期结局。入组患者为复发/难治性多发性骨髓瘤（既往接受过1-3线治疗）。伊沙妥昔单抗10 mg/kg在第1周期每周静脉给药一次，之后每两周一次。疗效分析在意向治疗人群中进行（Isa-Kd组：n=179；Kd组：n=123），安全性在接受治疗的患者中评估（Isa-Kd组：n=177；Kd组：n=122）。与中期分析结果一致，在Kd方案中加入伊沙妥昔单抗显著延长了PFS（风险比0.58，95.4%置信区间：0.42–0.79；中位PFS 35.7个月[95% CI: 25.8–44.0]对比19.2个月[95% CI: 15.8–25.0]）。Isa-Kd在各亚组中均观察到PFS获益，包括预后不良患者。严格完全缓解/完全缓解率分别为44.1%对比28.5%（比值比：2.09，95% CI: 1.26–3.48），微小残留病阴性率33.5%对比15.4%（比值比：2.78，95% CI: 1.55–4.99），微小残留病阴性完全缓解率26.3%对比12.2%（Isa-Kd组对比Kd组）。Isa-Kd的安全性与先前中期分析报告相似。这些发现进一步支持Isa-Kd作为复发多发性骨髓瘤患者的标准治疗方案。临床试验信息：ClinicalTrials.gov，NCT03275285。
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