CELL INTELLIGENCE · 肿瘤细胞治疗研究
肿瘤细胞治疗研究
英文原题：Ide-cel vs standard regimens in triple-class-exposed relapsed and refractory multiple myeloma: updated KarMMa-3 analyses.
Ide-cel vs standard regimens in triple-class-exposed relapsed and refractory multiple myeloma: updated KarMMa-3 analyses.
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在三类暴露（TCE）的复发/难治性多发性骨髓瘤（R/RMM）中，结局较差。在3期KarMMa-3试验中，患有TCE R/RMM且既往接受过2至4种方案的患者按2:1随机分配至idecabtagene vicleucel（ide-cel）或标准方案（SRs）。一项中期分析（IA）显示，与SRs相比，ide-cel的中位无进展生存期（PFS；主要终点；13.3 vs 4.4个月；P < .0001）显著更长，总缓解率（ORR）更高。在最终PFS分析中（中位随访，30.9个月），与SRs相比，ide-cel进一步改善了中位PFS（13.8 vs 4.4个月；风险比[HR]，0.49；95%置信区间[CI]，0.38-0.63）。无论既往治疗线数如何，均观察到ide-cel相较于SRs的PFS获益，其中既往2线治疗后的获益最大（分别为16.2 vs 4.8个月）。
ide-cel相较于SRs的ORR获益得以维持（71% vs 42%；完全缓解，44% vs 5%）。以患者为中心的设计允许SRs组（56%）在疾病进展后交叉至ide-cel，这混杂了总生存期（OS）的解释。在OS的IA中，ide-cel和SRs的中位OS分别为41.4（95% CI，30.9至未达到[NR]）vs 37.9（95% CI，23.4至NR）个月（HR，1.01；95% CI，0.73-1.40）；两臂的中位OS均长于历史数据（9-22个月）。两项针对交叉调整的预设分析显示OS有利于ide-cel。该试验强调了个体化桥接治疗的重要性，以确保ide-cel生产期间充分的疾病控制。与SRs相比，ide-cel改善了患者报告结局。未报告新的安全性信号。这些结果证明ide-cel在早期线和TCE R/RMM中持续具有有利的获益-风险特征。该试验注册于www.ClinicalTrials.gov，编号为#NCT03651128。
Outcomes are poor in triple-class-exposed (TCE) relapsed and refractory multiple myeloma (R/RMM). In the phase 3 KarMMa-3 trial, patients with TCE R/RMM and 2 to 4 prior regimens were randomized 2:1 to idecabtagene vicleucel (ide-cel) or standard regimens (SRs). An interim analysis (IA) demonstrated significantly longer median progression-free survival (PFS; primary end point; 13. 3 vs 4. 4 months; P < . 0001) and higher overall response rate (ORR) with ide-cel vs SRs. At final PFS analysis (median follow-up, 30. 9 months), ide-cel further improved median PFS vs SRs (13. 8 vs 4. 4 months; hazard ratio [HR], 0. 49; 95% confidence interval [CI], 0. 38-0. 63). PFS benefit with ide-cel vs SRs was observed regardless of number of prior lines of therapy, with greatest benefit after 2 prior lines (16. 2 vs 4. 8 months, respectively). ORR benefit was maintained with ide-cel vs SRs (71% vs 42%; complete response, 44% vs 5%).
Patient-centric design allowed crossover from SRs (56%) to ide-cel upon progressive disease, confounding overall survival (OS) interpretation. At IA of OS, median was 41. 4 (95% CI, 30. 9 to not reached [NR]) vs 37. 9 (95% CI, 23. 4 to NR) months with ide-cel and SRs, respectively (HR, 1. 01; 95% CI, 0. 73-1. 40); median OS in both arms was longer than historical data (9-22 months). Two prespecified analyses adjusting for crossover showed OS favoring ide-cel.
This trial highlighted the importance of individualized bridging therapy to ensure adequate disease control during ide-cel manufacturing. Ide-cel improved patient-reported outcomes vs SRs. No new safety signals were reported. These results demonstrate the continued favorable benefit-risk profile of ide-cel in early-line and TCE R/RMM. This trial was registered at www. ClinicalTrials. gov as #NCT03651128.
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