Phase 3, open-label, randomized trial comparing safety and efficacy of belamaf to Pd in RRMM: DREAMM-3 study (https://www.myeloma.org/videos/phase-3-open-label-randomized-trial-comparing-safety-efficacy-belamaf-pd-rrmm-dreamm-3-study)
Comparing the Safety and Efficacy of Belamaf to Pd in RRMM
Evaluating the phase 3, open-label, randomized DREAMM-3 study
Dr. Katja Weisel presented a study evaluating the efficacy and safety of single-agent belantamab mafodotin (belamaf) (a first-in-class antibody drug conjugate) compared to pomalidomide plus low-dose dexamethasone in patients with relapsed and refractory multiple myeloma. The trial, known as the DREAMM-3 trial, included 325 patients and assessed progression-free survival as the primary endpoint. Although belamaf demonstrated a longer median progression-free survival compared to pomalidomide, the difference did not reach statistical significance. However, belamaf showed a deeper and more durable response rate, with a higher rate of stringent complete responses. The adverse events were manageable, with ocular toxicity being the most notable side effect, which was reversible in most cases. Patient-reported outcomes indicated that belamaf was well tolerated and had a positive impact on important health outcomes.
- The DREAMM-3 trial compared single-agent belamaf to pomalidomide plus low-dose dexamethasone in patients with relapsed and refractory multiple myeloma.
- The trial included 325 patients and evaluated progression-free survival as the primary endpoint.
- Belamaf, a first-in-class antibody drug conjugate, targets BCMA and induces cell death through various mechanisms.
- The median age of the patients was 68, and about 20% of patients were triple refractory.
- The median progression-free survival was longer for belamaf (11.2 months) compared to pomalidomide (7.0 months), although the difference was not statistically significant.
- The response rate was higher for belamaf compared to pomalidomide, with a more durable and deeper response observed.
- The adverse events were manageable, with neutropenia being more pronounced in the pomalidomide group.
- Ocular toxicity was a notable side effect of belamaf, but it was mostly reversible.
- Patient-reported outcomes indicated that belamaf was well tolerated and had a positive impact on important health outcomes.
Authors:
Katja Weisel, Vania TM Hungria, Atanas Radinoff, Sosana Delimpasi, Gabor Mikala, Tamas Masszi, Jian Li, Marcelo Capra, Morio Matsumoto, Neal Sule, Mary Li, Astrid McKeown, Wei He, Shelley Bright, Brooke Currie, Julia Boyle, Joanna Opalinska, Meletios A. Dimopoulos
Doctor Bio:
Dr. Katja Weisel, University Medical Center Hamburg-Eppendorf, is a Medical Specialist in Internal Medicine and Hematology and Oncology. Dr. Weisel’s myeloma research interests focus on treatment optimization for high-risk myeloma, renally-impaired myeloma patients, refractory myeloma patients, and radiographic methods for disease monitoring of myeloma. Professor Weisel has contributed to over 100 publications on multiple myeloma treatment and biology.