The FDA approved the first anti-BCMA therapy, belantamab mafodotin-blmf, to treat patients with relapsed/refractory multiple myeloma who have received 4 prior therapies.
The Food and Drug Administration approved belantamab mafodotin-blmf (Blenrep) for the treatment of patients with relapsed/refractory multiple myeloma who have received 4 prior therapies, according to GlaxoSmithKline.1
Moreover, the company noted belantamab mafodotin-blmf is the first anti-BCMA therapy approved anywhere in the world.
“As the second most common form of blood cancer in the US, multiple myeloma is an incurable and devastating disease,” Dr. Hal Barron, chief scientific officer and president of research and development at GSK, said in a press release. “Blenrep is the first approved anti-BCMA therapy and has the potential to transform the treatment of patients with relapsed or refractory myeloma who have limited treatment options today.
The indication, which includes patients who have received 4 prior therapies including an anti-CD38 monoclonal antibody or a proteasome inhibitor and an immunomodulatory agent, is approved under accelerated approval, based on 6-month primary results from the pivotal, open-label, 2-arm, phase II DREAMM-2 trial.2
In particular, the approval was based on the overall response rate of 31% (97.5% CI, 20.8-42.6) in patients with relapsed/refractory multiple myeloma who received the treatment at the recommended 2.5 mg/kg dose. In patients who received belantamab mafodotin at 3.4 mg/kg, the ORR was 34% (97.5% CI; 23.9-46.0).
In the 2.5-mg/kg cohort, 19% of patients (n = 18) experienced a very good partial response (VGPR) or better, while 20% (n = 20) of those in the 3.4 mg/kg cohort experienced the same response.
In addition, the median duration of response had not been reached at the six-month analysis. Of the 73% of patients who responded to therapy, however, their duration of response was six months or longer.
The median progression-free survival was 2.9 months (95% CI, 2.1-3.7) and 4.9 months (95% CI, 2.3-6.2) in the 2.5-mg/kg and 3.4-mg/kg cohorts, respectively. Overall survival data were immature at the time of the analysis.
The most frequently reported grade 3/4 adverse events (AEs) included keratopathy (27% in the 2.5-mg/kg cohort vs 21% in the 3.4-mg/kg cohort), thrombocytopenia (20% vs 33%, respectively) and anemia (20% vs 25%, respectively).
“While treatable, refractory multiple myeloma is a significant clinical challenge with poor outcomes for patients whose disease has become resistant to the current standard of care,” principal investigator Dr. Sagar Lonial, chief medical officer at Winship Cancer Institute of Emory University in Atlanta, Georgia, and chair of the Emory Department of Hematology and Medical Oncology, said in the release.
“Due to the limited options currently available, these patients are often retreated with drugs from the same classes after they relapse, which is why the approval of Blenrep, the first anti-BCMA therapy, is significant for both patients and physicians alike,” he added.
Of note, continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials, according to the GSK release.
1. US Food and Drug Administration (FDA) grants priority review of belantamab mafodotin for patients with relapsed or refractory multiple myeloma [news release]: London, UK. Published January 21, 2020. https://www.gsk.com/en-gb/media/press-releases/fda-approves-gsk-s-blenrep-belantamab-mafodotin-blmf-for-the-treatment-of-patients-with-relapsed-or-refractory-multiple-myeloma/. Accessed January 21, 2020.
2. Lonial S, Lee HC, Badros A, et al. Belantamab mafodotin for relapsed or refractory multiple myeloma (DREAMM-2): a two-arm, randomised, open-label, phase 2 study [published online December 16, 2019]. Lancet Oncol. https://doi.org/10.1016/S1470-2045(19)30788-0.