DREAMM-6: Evaluating Belantamab Mafodotin and Bortezomib Plus Dexamethasone in Relapsed/Refractory Myeloma

Early data from the DREAMM-6 study suggest that the combination of belantamab mafodotin, bortezomib, and dexamethasone is active in patients with relapsed or refractory multiple myeloma (MM). These findings were presented by Ajay Nooka, MD, of the Winship Cancer Institute at Emory University in Atlanta, Georgia, as part of the ASCO20 Virtual Scientific Program.

In the phase II DREAMM-2 study, results of which were published in The Lancet Oncology in December 2019, single-agent anti-B-cell maturation antigen (BCMA) antibody drug conjugate belantamab mafodotin resulted in clinical responses in patients with MM whose disease was refractory to an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.

In the DREAMM-6 trial, 52 patients were enrolled in a two-part, two-arm study of belantamab mafodotin combined with either bortezomib/dexamethasone or lenalidomide/dexamethasone. In the part I dose escalation study, 13 patients were enrolled, while 45 patients were enrolled in the part II dose expansion study. Dr. Nooka presented results on the bortezomib/dexamethasone arm of the part II dose expansion study, which included 18 patients.

At data cutoff, patients had been treated with 2.5 mg/kg belantamab mafodotin plus bortezomib dexamethasone for a median of 18.2 weeks. Grade 3/4 adverse events (AEs) were reported in 89% of patients, with 28% of patients experiencing AEs leading to permanent discontinuation of study treatment.

The most common AEs were infusion-related reactions and thrombocytopenia, as well as corneal events including keratopathy, blurred vision, and dry eye. Keratopathy is expected with belantamab mafodotin and was managed with dose modifications, Dr. Nooka said.

The overall response rate was 78%, with 50% of patients experiencing at least a very good partial response.

Dr. Nooka noted that duration of response has not yet been reached. “Findings for the remainder of the study will be presented at future meetings when data become mature and available,” Dr. Nooka said.

References

  1. Nooka AK, Stockerl-Goldstein K, Quch H, et al. DREAMM-6: Safety and tolerability of belantamab mafodotin in combination with bortezomib/dexamethasone in relapsed/refractory multiple myeloma (RRMM). J Clin Oncol. 2020;38(suppl):abstr 8502. Presented as part of the ASCO20 Virtual Scientific Program. May 29-31, 2020.
  2. Lonial S, Lee HC, Badros A, et al. Belantamab mafodotin for relapsed or refractory multiple myeloma (DREAMM-2): A two-arm, randomized, open-label, phase II study. Lancet Oncol. 2020 Feb;21(2):207-221.