DREAMM-8: Belantamab mafodotin + pomalidomide and dex shows improved outcomes in RR multiple myeloma

Results from the randomized phase 3 DREAMM-8 study of belantamab mafodotin plus pomalidomide and dexamethasone (BPd) vs pomalidomide plus bortezomib and dexamethasone (PVd) in relapsed/refractory multiple myeloma (RRMM)
The DREAMM-8 study evaluated the efficacy and safety of belantamab mafodotin plus pomalidomide and dexamethasone (BPd) versus pomalidomide plus bortezomib and dexamethasone (PVd) in patients with relapsed/refractory multiple myeloma (RRMM). The study included 155 patients in the BPd arm and 147 patients in the PVd arm. The primary endpoint of independent review committee-assessed progression-free survival (PFS) was met, with a statistically significant and clinically meaningful PFS benefit observed in the BPd arm compared to the PVd arm. The 12-month PFS rate was also higher in the BPd arm (71% vs 51%). The overall response rate (ORR) was 77% in the BPd arm and 72% in the PVd arm, with a higher rate of complete response or better in the BPd arm (40% vs 16%). The median duration of response was not reached in the BPd arm and was 17.5 months in the PVd arm. Adverse events (AEs) were reported in over 99% of patients in the BPd arm and 96% in the PVd arm, with ocular AEs being more common in the BPd arm (grade 3/4 in 43% vs 2% in the PVd arm). The safety profile of both regimens was manageable and consistent with the known safety profile of the individual agents.
Key Points:
- The DREAMM-8 study demonstrated a significant and clinically meaningful improvement in progression-free survival (PFS) with belantamab mafodotin plus pomalidomide and dexamethasone (BPd) compared to pomalidomide plus bortezomib and dexamethasone (PVd) in patients with relapsed/refractory multiple myeloma (RRMM).
- The 12-month PFS rate was higher in the BPd arm (71% vs 51%).
- The overall response rate (ORR) was 77% in the BPd arm and 72% in the PVd arm, with a higher rate of complete response or better in the BPd arm (40% vs 16%).
- The median duration of response was not reached in the BPd arm and was 17.5 months in the PVd arm.
- Adverse events (AEs) were reported in over 99% of patients in the BPd arm and 96% in the PVd arm, with ocular AEs being more common in the BPd arm (grade 3/4 in 43% vs 2% in the PVd arm).
- The safety profile of both regimens was manageable and consistent with the known safety profile of the individual agents.
Authors:
Suzanne Trudel, Meral Beksac, Luděk Pour, Sosana Delimpasi, Hang Quach, Vladimir I. Vorobyev, Michele Cavo, Kazuhito Suzuki, Pawel Robak, Kristin Morris, Amy Phillips-Jones, Xiaoou Linnette Zhou, Giulia Fulci, Neal Sule, Brandon Kremer, Joanna Opalinska, Maria-Victoria Mateos, Meletios Athanasios Dimopoulos
Clinical Trial Registration Number: NCT04484623
ASCO Abstract# LBA105
DOI: 10.1200/JCO.2024.42.17_suppl.LBA105
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