The FDA recommended that the marketing application for belantamab mafodotin-blmf for patients with previously treated relapsed/refractory multiple myeloma be withdrawn after determining that findings did not meet the requirements for accelerated approval.
Withdrawal of marketing authorization for belantamab mafodotin-blmf (Blenrep) in patients with relapsed/refractory multiple myeloma treated with at least 4 previous therapies has begun following a recommendation from the FDA, according to a press release from GSK.1
The request to withdraw authorization followed results from the confirmatory phase 3 DREAMM-3 study (NCT04162210), which the FDA explained failed to qualify belantamab mafodotin-blmf for accelerated approval. GSK stated that after assessing all the data currently available from the trial, the risk-benefit profile of belantamab mafodotin may still be beneficial to patients with relapsed/refractory multiple myeloma. In particular, patients who responded to treatment with the agent experienced long-lasting benefit and tolerable toxicities.
A recent readout indicated that the study did not meet its primary end point of progression-free survival, with investigators reporting a median of 11.2 months in the belantamab mafodotin arm vs 7.0 months in the pomalidomide and dexamethasone arm (HR, 1.03; 95% CI, 0.72-1.47).2 Additional data from the readout indicated that the overall response rate was 41% vs 36% in each respective arm, as well as a very good partial response or better rate of 25% vs 8%, respectively.
“We respect the agency’s approach to the accelerated approval regulations and associated process,” Sabine Luik, chief medical officer at GSK, said in the 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 US FDA on a path forward for this important treatment option for patients with multiple myeloma.”
Other trials under the DREAMM clinical trial program are set to continue assessing the efficacy of belantamab mafodotin in combination regimens that include both novel therapeutics and standards of care. These trials will focus on assessing the regimens in early lines of treatment, as well as optimizing dosing to maximize efficacy and minimize keratopathy events. Data from the phase 3 DREAMM-7 trial (NCT04246047)—assessing belantamab mafodotin plus bortezomib and dexamethasone in relapsed/refractory multiple myeloma—and the phase 3 DREAMM-8 trial (NCT04484623)—examining belantamab mafodotin plus pomalidomide/dexamethasone in relapsed/refractory multiple myeloma—are anticipated to read out in the first half of 2023.
At a median follow-up of 11.5 months and 10.8 months in the belantamab mafodotin and pomalidomide/dexamethasone arms, respectively, the median duration of response (DOR) was not reached (NR; 95% CI,17.9-NR) and 8.5 months (95% CI, 7.6-NR), respectively. Moreover, the 12-month DOR rate was 76.8% in the belantamab mafodotin arm and 48.4% in the pomalidomide/dexamethasone arm. No new safety signals were reported, and events of grade 3 keratopathy were consistent with previously reported findings.