Richardson Paul, Beksaç Meral, Oriol Albert, Lindsay Jindriska, Schjesvold Fredrik, Galli Monica, Yağcı Münci, Larocca Alessandra, Weisel Katja, Yu Xin, Donahue Cynthia, Acosta Jorge, Peluso Teresa, Dimopoulos Meletios
Jerome Lipper Multiple Myeloma Center, Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts, USA.
Istinye University Ankara Liv Hospital, Ankara, Turkey.
Eur J Haematol. 2025 May;114(5):822-831. doi: 10.1111/ejh.14365. Epub 2025 Jan 8.
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.
Adults with RRMM who had 1-3 prior regimens, including lenalidomide (≥ 2 cycles), were assigned (1:1) to PVd or Vd.
PFS. Prespecified secondary endpoint: OS. Prespecified exploratory endpoints: PFS2 and subgroup efficacy analyses.
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.
Findings showed a nonsignificant trend towards improved OS with PVd versus Vd. PFS2 favored PVd, supporting its use in RRMM.
在OPTIMISMM试验中，与硼替佐米/地塞米松（Vd）相比，泊马度胺/硼替佐米/地塞米松（PVd）显著延长了来那度胺暴露的复发难治性多发性骨髓瘤（RRMM）患者的中位无进展生存期（PFS）。我们报告最终总生存期（OS）和更新后的疗效分析。
有1-3种既往治疗方案（包括来那度胺（≥2个周期））的RRMM成人患者按1:1分配至PVd或Vd组。
PFS。预设次要终点：OS。预设探索性终点：PFS2和亚组疗效分析。
总事件发生率为70.0%，意向性治疗人群（N = 559）的OS数据成熟。中位随访64.5个月（数据截止：2022年5月13日）后，PVd组的中位OS为35.6个月，Vd组为31.6个月（风险比0.94，95%置信区间0.77-1.15，p = 0.571）；调整后续治疗后，与Vd相比，PVd组的OS有所改善（风险比0.76，95%置信区间0.619-0.931，p = 0.008）。中位PFS2分别为22.1个月和16.9个月（风险比0.77，95%置信区间0.64-0.94，名义p = 0.008）。治疗中出现的不良事件分别导致PVd组和Vd组92例（33.1%）和53例（19.6%）患者停用研究药物。
研究结果显示，与Vd相比，PVd组OS改善的趋势不显著。PFS2支持PVd，表明其可用于RRMM。
