The phase 3 DREAMM-7 trial met its primary end point of progression-free survival, and overall survival data is trending positively.
The combination of belantamab mafodotin (Blenrep) and bortezomib (Velcade) plus dexamethasone (BorDex) as a second-line treatment showed statistically significant improvements in progression-free survival (PFS) compared with daratumumab (Darzalex) and BorDex in the treatment of patients with relapsed or refractory multiple myeloma (RRMM).1
These findings come from the phase 3 DREAMM-7 (NCT04246047) trial which showed that with a PFS improvement, the study met its primary end point. The trial is still evaluating overall survival (OS), but it is trending positively with a nominal P value of <.0005.
The safety and tolerability of the belantamab mafodotin regimen was consistent with the known safety profiles of the individual agents. Findings from the DREAMM-2 study (NCT03525678) previously presented at the 2022 American Society for Hematology annual meeting showed that 71% of patients receiving 2.5 mg/kg of belantamab mafodotin had keratopathy, with 29% of patients experiencing grade 3 keratopathy and 1 patient experiencing grade 4 keratopathy. Further, 25% of patients in the 2.5 mg/kg cohort had blurred vision, and 48% of patients experienced best corrected visual acuity reduced to 20/50 or worse.2
“Patients with multiple myeloma need treatment options after first relapse that are efficacious, readily accessible, and have novel mechanisms of action. We are particularly encouraged by the potential for belantamab mafodotin when combined with BorDex to address high unmet need in relapsed/refractory multiple myeloma, given the head-to-head comparison with the daratumumab-based standard of care regimen,” said Hesham Abdullah, senior vice president, global head oncology, Research and Development, GSK, in a press release.1
Previously, the FDA pulled belantamab mafodotin from the market in November 2022 after the phase 3 confirmatory DREAMM-3 trial (NCT04162210) did not meet the FDA’s accelerated approval requirements.
The phase 3 DREAMM-7 trial is a multicenter, open-label, randomized study investigating the safety and efficacy of belantamab mafodotin in combination with BorDex vs daratumumab plus BorDex in patients with RRMM.The primary end point is PFS, and secondary end points include complete response rate, overall response rate, clinical benefit rate, duration of response, time to response, time to progression, OS, PFS2, minimal residual disease, and incidence of adverse events (AEs).3
Overall, 494 patients were randomized 1:1 to the belantamab mafodotin or daratumumab arms. Patients in the belantamab mafodotin arm received 2.5 mg/kg of the agent administered intravenously every 3 weeks.1
To be eligible to participate, patients must have received at least 1 prior line of therapy for MM, have adequate organ function, and an ECOG performance status of 0-2. All prior treatment-related AEs must be resolved to grade 1 or lower, with the exception of alopecia.3
Patients are not eligible for the study if they are intolerant to daratumumab, refractory to daratumumab or other anti-CD38 therapy, or intolerant or refractory to bortezomib. Patients also cannot have grade 2 or higher peripheral neuropathy or neuropathic pain, received a prior allogeneic stem cell transplant, or received prior anti-B-cell maturation antigen therapy.
The study has an estimated completion date of June 2026.2 Results from an interim analysis will be reported at an upcoming scientific meeting.1