KEY TAKEAWAYS
- The DREAMM‑3 phase III trial compared the effectiveness of single-agent Belamaf with the Pd doublet in adults with RRMM.
- Progression-free survival (PFS) was the study’s primary endpoint.
- The study confirmed that Belamaf yielded deeper and more enduring responses than Pd.
In the DREAMM‑3 phase III study, patients (pts) were randomly assigned (2:1) to receive either Belamaf at a dose of 2.5 mg/kg intravenously every 3 weeks or the Pd regimen (oral pomalidomide 4 mg/day on days 1–21 of each 28-day cycle; oral dexamethasone 40 mg once weekly, reduced to 20 mg if aged >75 years). The study’s primary endpoint was progression-free survival (PFS).
In total, 325 pts were enrolled, with 218 in the Belamaf group and 107 in the Pd group. The median age was 68 years, and the median duration of exposure was 4.1 months for Belamaf and 5.3 months for Pd. The median follow-up period was 11.5 months for Belamaf and 10.8 months for Pd. Although the median PFS was 11.2 months for Belamaf and 7.0 months for Pd, the hazard ratio (HR) of 1.03 was not statistically significant (P=0.558). Overall response rates were similar between the two groups (Belamaf, 41%; Pd, 36%), but notably, rates of achieving a very good partial response or better were 25% for Belamaf and 8% for Pd. The duration of response for Belamaf was notably more enduring, with a median duration that was not reached (NR) (ranging from 17.9 to NR), compared to 8.5 months (ranging from 7.6 to NR) for Pd.
At the 12-month mark, the probability of maintaining a response was 77% for Belamaf and 50% for Pd. The median progression-free survival from randomization to progression on subsequent lines of therapy (PFS2) was 18.7 months for Belamaf and 12.7 months for Pd. Overall survival (OS) data were still preliminary (37.5% overall maturity at primary analysis), with a median OS of 21.2 months for Belamaf and 21.1 months for Pd (HR=1.14; P=0.746). Importantly, no new safety concerns emerged, and any ocular toxicity observed was effectively managed through dose adjustments.
Although Belamaf did not demonstrate clear superiority in terms of PFS, it did induce deeper and more durable responses compared to the Pd doublet. There were no new safety issues reported. Additionally, patient-reported outcomes will be presented. Ongoing research continues to explore the combination of Belamaf with established and novel agents.
Source: https://clml-soho2023.elsevierdigitaledition.com/504/index.html
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT04162210
Weisel, K., Hungria, V. T., Radinoff, A., Delimpasi, S., Gabor, M., Masszi, T., Li, J., Capra, M., Matsumoto, M., Sule, N., Li, M., McKeown, A., He, W., Bright, S., Currie, B., Boyle, J., Opalinska, J., Dimopoulos, M. A. (2023). MM-509 A Phase III, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Single-Agent Belantamab Mafodotin (Belamaf) Compared With Pomalidomide Plus Low-Dose Dexamethasone (Pd) in Patients With Relapsed or Refractory Multiple Myeloma (RRMM) (DREAMM-3). Clinical Lymphoma Myeloma and Leukemia, 23, S504-S505. https://doi.org/10.1016/S2152-2650(23)01462-3
