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

Richardson P., Beksaç M., Oriol A., Lindsay J., Schjesvold F., Galli M., ...Daha Fazla

European Journal of Haematology, cilt.114, sa.5, ss.822-831, 2025 (SCI-Expanded, Scopus) identifier

  • Yayın Türü: Makale / Tam Makale
  • Cilt numarası: 114 Sayı: 5
  • Basım Tarihi: 2025
  • Doi Numarası: 10.1111/ejh.14365
  • Dergi Adı: European Journal of Haematology
  • Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus, Academic Search Premier, BIOSIS, CAB Abstracts, EMBASE, MEDLINE, Veterinary Science Database
  • Sayfa Sayıları: ss.822-831
  • Anahtar Kelimeler: OS, phase 3 trial, pomalidomide, relapsed or refractory multiple myeloma
  • Gazi Üniversitesi Adresli: Evet

Özet

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.