CELL INTELLIGENCE · 肿瘤细胞治疗研究
肿瘤细胞治疗研究
英文原题：Matching adjusted indirect comparisons of efficacy outcomes for idecabtagene vicleucel (ide-cel, bb2121) versus selinexor + dexamethasone and belantamab mafodotin in relapsed and refractory multiple myeloma.
Matching adjusted indirect comparisons of efficacy outcomes for idecabtagene vicleucel (ide-cel, bb2121) versus selinexor + dexamethasone and belantamab mafodotin in relapsed and refractory multiple myeloma.
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Idecabtagene vicleucel（ide-cel，bb2121）是一种嵌合抗原受体（CAR）T 细胞疗法，已在单臂 II 期 KarMMa 临床试验中用于复发/难治性多发性骨髓瘤（RRMM）患者；这些患者既往接受过免疫调节药物、蛋白酶体抑制剂和抗 CD38 抗体。美国目前批准了两种作用机制不同的疗法：selinexor 联合地塞米松（Sd）和 belantamab mafodotin（BM），用于经多线治疗的患者，包括三类药物均耐药者。
本研究采用匹配调整间接比较，比较 ide-cel 与 Sd 以及 ide-cel 与 BM。与两种方案相比，ide-cel 均延长无进展生存期（PFS）和总生存期（OS）。PFS：ide-cel 对 Sd，风险比（HR）0.46，95% 置信区间（CI）0.28–0.75；ide-cel 对 BM，HR 0.45，95% CI 0.27–0.77。OS：ide-cel 对 Sd，HR 0.23，95% CI 0.13–0.42；ide-cel 对 BM，HR 0.35，95% CI 0.14–0.87。这些结果提示，对于经多线治疗的 RRMM 患者，ide-cel 相比目前获批方案可带来具有临床意义的改善。
Idecabtagene vicleucel (ide-cel, bb2121), a chimeric antigen receptor (CAR) T cell therapy, has been investigated in patients with relapsed and refractory multiple myeloma (RRMM) who have received an immunomodulatory drug, proteasome inhibitor, and anti-CD38 antibody in the single-arm phase 2 KarMMa clinical trial. Two therapies with distinct mechanisms of action - selinexor plus dexamethasone (Sd) and belantamab mafodotin (BM) - are currently approved in the United States for heavily pretreated patients, including those who are triple-class refractory.
To compare ide-cel versus Sd and ide-cel versus BM, matching-adjusted indirect comparisons were performed. Ide-cel extended progression-free survival (PFS) and overall survival (OS) versus both Sd and BM (hazard ratio (HR); 95% confidence interval (CI)). PFS: ide-cel versus Sd, 0.
46; 0. 28-0. 75; ide-cel versus BM, 0. 45; 0. 27-0. 77. OS: ide-cel versus Sd, 0. 23; 0. 13-0. 42; ide-cel versus BM, 0. 35; 0. 14-0. 87. These results suggest ide-cel offers clinically meaningful improvements over currently approved regimens for patients with heavily pretreated RRMM.
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