CELL INTELLIGENCE · 肿瘤细胞治疗研究
肿瘤细胞治疗研究
英文原题：Elotuzumab in combination with pomalidomide, bortezomib, and dexamethasone in relapsed and refractory multiple myeloma.
Elotuzumab in combination with pomalidomide, bortezomib, and dexamethasone in relapsed and refractory multiple myeloma.
分数与星级只用于站内排序 —— 不代表疗效、安全性或个人适用性。
Elotuzumab是一种靶向浆细胞和NK 细胞上信号淋巴细胞激活分子F7的单克隆抗体，可增强来那度胺、泊马度胺和硼替佐米在多发性骨髓瘤（MM）中的活性。OPTIMISMM研究显示，泊马度胺、硼替佐米和地塞米松（PVd）联合方案在复发/难治性MM中改善了结局。
因此，我们在多中心2期试验中研究了在PVd基础上加用elotuzumab（elo-PVd）治疗复发/难治性MM。主要目的是确定总缓解率（ORR）。复发/难治性疾病且既往接受过≥1线治疗（包括来那度胺和蛋白酶体抑制剂）的患者符合条件。每28天为一个周期，elotuzumab在前2个周期每周给药，之后每2周给药；泊马度胺第1至21天给药；硼替佐米第1、8和15天给药；地塞米松每周给药。该试验入组48例患者，既往治疗线数中位数为3（范围，1-9）。既往治疗包括泊马度胺（33%）、daratumumab（25%）和isatuximab（4%）。ORR为56.3%，中位无进展生存期（PFS）为10个月。在既往接受过1线治疗的患者中，ORR为73.7%；中位PFS为23.4个月。常见的≥3级不良事件为中性粒细胞减少（33%）；感染，任何（33%）；肺部感染（27%）；低磷血症（19%）；以及血小板减少（15%）。据我们所知，elo-PVd是复发/难治性MM中首批包含单克隆抗体的四联方案试验之一，显示在不同既往治疗中均有效，包括既往接受过抗CD38单克隆抗体的三类药物暴露患者。该试验已在ClinicalTrials.gov注册，注册号为#NCT02718833。
Elotuzumab is a monoclonal antibody targeting signaling lymphocyte activation molecule F7 on plasma and natural killer cells, which enhances the activity of lenalidomide, pomalidomide, and bortezomib in multiple myeloma (MM). The OPTIMISMM study showed improved outcomes with the combination of pomalidomide, bortezomib, and dexamethasone (PVd) in relapsed/refractory MM.
Therefore, we studied adding elotuzumab to PVd (elo-PVd) in relapsed/refractory MM in a multicenter phase 2 trial. The primary objective was to determine the overall response rate (ORR). Patients with relapsed/refractory disease and ≥1 prior line of treatment (including lenalidomide and a proteasome inhibitor) were eligible. For each 28-day cycle, elotuzumab was weekly for the first 2 cycles and then every other week; pomalidomide on days 1 to 21; bortezomib on days 1, 8, and 15; and dexamethasone weekly. The trial enrolled 48 patients with a median 3 prior lines (range, 1-9). Prior therapies included pomalidomide (33%), daratumumab (25%), and isatuximab (4%).
The ORR was 56. 3%, and the median progression-free survival (PFS) was 10 months. In patients with 1 prior line of therapy, ORR was 73. 7%; median PFS was 23. 4 months. Common grade ≥3 adverse events were neutropenia (33%); infections, any (33%); lung infection (27%); hypophosphatemia (19%); and thrombocytopenia (15%).
Elo-PVd is, to our knowledge, one of the first trials of a quadruplet regimen in relapsed/refractory MM incorporating a monoclonal antibody to show efficacy across diverse prior treatments, including triple-class exposed patients with prior anti-CD38 monoclonal antibody. This trial was registered at ClinicalTrials. gov as #NCT02718833.
在 PubMed 查看 → 出版商原文（DOI） 全文 PDF（PMC）· 可下载 治疗专题与资料阅读指南 资料来源与翻译说明 报告译文或资料问题 →
MEMBER ACCOUNT
登录成功会直接打开下一页。
