A confirmatory trial in patients with relapsed or refractory multiple myeloma did not meet its primary endpoint of progression-free survival.
GSK is withdrawing Blenrep (belantamab mafodotin-blmf) from the U.S. market at the request of the FDA. The agency made the request after the DREAMM-3 phase 3 confirmatory trial failed to meet its endpoints. Blenrep is a monotherapy treatment for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior therapies.
The FDA had granted accelerated approval of Blenrep in August 2020 based on the DREAMM-2 endpoint of overall response rate. It was the first in a new class of drugs known as anti-BCMA (B-cell maturation antigen) monoclonal antibodies. The BCMA pathway has been shown to be important for myeloma cell growth and survival.
Multiple myeloma is the second most common blood cancer in the United States and is generally considered treatable but not curable. In the United States, more than 32,000 people are estimated to be diagnosed with multiple myeloma this year, and nearly 13,000 people will die from the disease.
“We respect the agency’s approach to the accelerated approval regulations and associated process,” Sabine Luik, chief medical officer, said in a press 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 U.S. FDA on a path forward for this important treatment option for patients with multiple myeloma.”
DREAMM-3, a head-to-head superiority trial of Blenrep monotherapy versus pomalidomide in combination with low dose dexamethasone, did not meet its primary endpoint of progression-free survival (PFS), the company recently announced. The primary endpoint of progression-free survival demonstrated a hazard ratio of 1.03. A hazard ration of more than 1 indicates an increased risk of harm.
The overall response rate was 41% for Blenrep and 36% for the pomalidomide/dexamethasone combination. Duration of response rates at 12 months was 76.8% for Blenrep and 48.4% for pomalidomide/dexamethasone. The safety and tolerability profile of Blenrep was consistent with the known safety profile, and no new safety signals were identified.
Additional trials within the DREAMM clinical trial program are designed to determine the benefit of Blenrep in combination treatment with novel therapies and standard-of-care treatments in earlier lines of therapy. Results from DREAMM-7 and DREAMM-8 phase 3 trials are anticipated in the first half of 2023.
Patients already enrolled in the Blenrep Risk Evaluation and Mitigation Strategy (REMS) program will have the option to enroll in a compassionate use program to continue to access treatment.