November 22, 2022
2 min read
GSK has started the process of withdrawing belantamab mafodotin-blmf from the U.S. market.
The FDA requested the action after a confirmatory trial of the multiple myeloma therapy failed to meet requirements specified under the agency’s accelerated approval regulations.
Belantamab mafodotin-blmf (Blenrep, GSK) is an antibody-drug conjugate comprising a humanized B-cell maturation antigen (BCMA) monoclonal antibody conjugated to the cytotoxic agent auristatin F via a non-cleavable linker.
The FDA granted accelerated approval to the agent in 2020 for adults with multiple myeloma who received at least four prior therapies, including an immunomodulatory agent, proteasome inhibitor and anti-CD38 antibody.
The FDA made the approval contingent on confirmed clinical benefit from the randomized phase 3 DREAMM-3 trial.
The open-label trial included 325 participants randomly assigned 2:1 to single-agent belantamab mafodotin-blmf dosed at 2.5 mg/kg every 3 weeks, or pomalidomide (Pomalyst, Bristol Myers Squibb) administered daily on days 1 to 21 of each 28-day cycle with once-weekly dexamethasone.
As Healio previously reported, results showed no significant improvement in PFS — the study’s primary endpoint — with belantamab mafodotin-blmf (median, 11.2 months vs. 7 months; HR = 1.03; 95% CI, 0.72-1.47).
Secondary endpoints included overall response rate, duration of response and OS.
Researchers reported ORRs of 41% with belantamab mafodotin-blmf vs. 36% for pomalidomide-dexamethasone, with longer median duration of response (not reached vs. 8.5 months) and a higher rate of 12-month responses (76.8% vs. 48.4%) in the belantamab mafodotin-blmf group.
OS data — which had reached only 37.5% maturity — showed no significant difference between the belantamab mafodotin-blmf and pomalidomide-dexamethasone groups (HR = 1.14; 95% CI, 0.77-1.68).
Patients already enrolled in the Risk Evaluation and Mitigation Strategy program for the agent will be able to enroll in a compassionate use program to allow continued access to the treatment, according to a GSK press release.
Other trials in the DREAMM development program are evaluating belantamab mafodotin-blmf in combination with standard agents or novel therapies in earlier lines of therapy, as well as in an attempt to optimize dosing to maintain efficacy while reducing corneal events, according to a GSK press release.
Company officials believe based on all data available from the DREAMM development program that belantamab mafodotin-blmf’s risk-benefit profile remains favorable for this subgroup of patients with relapsed or refractory multiple myeloma, according to the release.
“We respect the agency’s approach to the accelerated approval regulations and associated process,” Sabine Luik, MD, MBA, GSK’s chief medical officer, said in the release. “Multiple myeloma is a challenging disease, with poor outcomes for patients whose disease has become resistant to standard-of-care treatments. We will continue the DREAMM clinical trial program and work with the [FDA] on a path forward for this important treatment option for patients with multiple myeloma.”