Pomalidomide, Bortezomib, and Dexamethasone Versus Bortezomib and Dexamethasone in Relapsed or Refractory Multiple Myeloma: Final Survival and Subgroup Analyses From the OPTIMISMM Trial.

IF 2.3 3区医学 Q2 HEMATOLOGY

European Journal of Haematology Pub Date : 2025-01-08 DOI:10.1111/ejh.14365

Paul Richardson, Meral Beksaç, Albert Oriol, Jindriska Lindsay, Fredrik Schjesvold, Monica Galli, Münci Yağcı, Alessandra Larocca, Katja Weisel, Xin Yu, Cynthia Donahue, Jorge Acosta, Teresa Peluso, Meletios Dimopoulos

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引用次数: 0

Abstract

Introduction: In the OPTIMISMM trial, pomalidomide/bortezomib/dexamethasone (PVd) significantly prolonged median progression-free survival (PFS) versus bortezomib/dexamethasone (Vd) in lenalidomide-exposed relapsed and refractory multiple myeloma (RRMM). We report final overall survival (OS) and updated efficacy analyses.

Methods: Adults with RRMM who had 1-3 prior regimens, including lenalidomide (≥ 2 cycles), were assigned (1:1) to PVd or Vd.

Primary endpoint: PFS. Prespecified secondary endpoint: OS. Prespecified exploratory endpoints: PFS2 and subgroup efficacy analyses.

Results: With an overall event rate of 70.0%, OS data were mature in the intent-to-treat population (N = 559). After median follow-up of 64.5 months (data cutoff: May 13, 2022), median OS was 35.6 months with PVd versus 31.6 months with Vd (HR 0.94, 95% CI 0.77-1.15, p = 0.571); adjusting for subsequent therapies, OS improved with PVd versus Vd (HR 0.76, 95% CI 0.619-0.931, p = 0.008). Median PFS2 was 22.1 versus 16.9 months, respectively (HR 0.77, 95% CI 0.64-0.94, nominal p = 0.008). Treatment-emergent adverse events led to study drug discontinuation in 92 (33.1%) and 53 (19.6%) patients in PVd and Vd arm, respectively.

Conclusions: Findings showed a nonsignificant trend towards improved OS with PVd versus Vd. PFS2 favored PVd, supporting its use in RRMM.

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泊马度胺、硼替佐米和地塞米松与硼替佐米和地塞米松治疗复发或难治性多发性骨髓瘤：来自OPTIMISMM试验的最终生存期和亚组分析

在OPTIMISMM试验中，泊马度胺/硼替佐米/地塞米松（PVd）与硼替佐米/地塞米松（Vd）相比显著延长了来那度胺暴露的复发和难治性多发性骨髓瘤（RRMM）的中位无进展生存期（PFS）。我们报告最终总生存期（OS）和最新的疗效分析。方法：有1-3个治疗方案的RRMM成人，包括来那度胺（≥2个周期），按1:1的比例分配到PVd或Vd组。主要终点：PFS。预先指定的辅助端点：操作系统。预先指定的探索性终点：PFS2和亚组疗效分析。结果：总体事件发生率为70.0%，意向治疗人群（N = 559）的OS数据成熟。中位随访64.5个月（数据截止日期：2022年5月13日）后，PVd的中位OS为35.6个月，Vd为31.6个月（HR 0.94, 95% CI 0.77-1.15, p = 0.571）；调整后续治疗后，PVd对Vd的OS改善（HR 0.76, 95% CI 0.619-0.931, p = 0.008）。中位PFS2分别为22.1个月和16.9个月（HR 0.77, 95% CI 0.64-0.94，名义p = 0.008）。治疗中出现的不良事件导致PVd组和Vd组分别有92例（33.1%）和53例（19.6%）患者停药。结论：研究结果显示PVd与Vd改善OS的趋势不显著。PFS2有利于PVd，支持其在RRMM中的应用。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

European Journal of Haematology 医学-血液学

CiteScore

5.50

自引率

0.00%

发文量

168

审稿时长

4-8 weeks

期刊介绍： European Journal of Haematology is an international journal for communication of basic and clinical research in haematology. The journal welcomes manuscripts on molecular, cellular and clinical research on diseases of the blood, vascular and lymphatic tissue, and on basic molecular and cellular research related to normal development and function of the blood, vascular and lymphatic tissue. The journal also welcomes reviews on clinical haematology and basic research, case reports, and clinical pictures.