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FDA gives the go-ahead for belantamab mafodotin in relapsed/refractory multiple myeloma

The U.S. Food and Drug Administration (FDA) has approved belantamab mafodotin-blmf (Blenrep®) for the treatment of patients with relapsed/refractory multiple myeloma who have previously received four prior lines of therapy,1 following results from the open-label, phase II DREAMM-2 trial (NCT03525678).

Despite several emerging therapies, multiple myeloma remains an incurable disease, and for relapsed/refractory patients who may have limited treatment options, the identification of novel targets for therapeutic interventions is of utmost importance.

Belantamab mafodotin-blmf, an antibody-drug conjugate, is the first approved therapy targeting the B-cell maturation antigen (BCMA) and contains a humanized anti-BCMA monoclonal antibody conjugated to monomethyl auristatin F (MMAF), a microtubule-disrupting cytotoxic agent.

The accelerated FDA approval of belantamab mafodotin comes on the heels of the 6-month primary results from the DREAMM-2 trial evaluating the use of the anti-BCMA antibody-drug conjugate in relapsed/refractory patients refractory to stem cell transplantation, alkylating agents, proteasome inhibitors (PIs) and immunomodulatory drugs (IMiDs).

At the time of the primary analysis data cut-off date, within the 2.5 mg/kg dose level cohort (n = 97), 31% of patients achieved an overall response (30/97 events; 97.5% CI, 20.8-42.6) and at the 3.4 mg/kg dose level (n = 99), 34% of patients achieved an overall response (34/99 events; 97.5% CI; 23.9-46.0).2

“The response rate continues to remain at 32%, the PFS is right around 3 months which is similar to every other drug that has been approved in a refractory myeloma setting. What we learned in this most recent update is the duration of response DOR was 11 months in the 2.5 mg/kg group, and the reason I highlight this is because if you look at other similar drugs, their DOR tends to be somewhere around 7-9 months. I think DOR speaks not just to the response rate but to the safety and tolerability of the treatment.”

Lead investigator of the DREAMM-2 study, Sagar Lonial, MD of Winship Cancer Institute of Emory University, Atlanta, GA.
 

Furthermore, belantamab mafodotin was shown to exhibit a manageable safety profile with 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) being the most common grade 3-4 adverse events reported.

The approval of belantamab mafodotin represents a promising alternative for patients whose disease has become refractory to the current standard treatment options.

References:

  1. GSK. FDA approves GSK’s BLENREP (belantamab mafodotin-blmf) for the treatment of patients with relapsed or refractory multiple myeloma. Available from: 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/ (Last accessed 07/08/20).
  2. Lonial S, Lee H, Badros A, et al. Belantamab mafodotin for relapsed or refractory multiple myeloma (DREAMM-2): a two-arm, randomized, open-label, phase 2 study. The Lancet Oncology. 2020;21(2):207-221.

Written by Solyana Yohannes