DREAMM-4 Trial Update of Belantamab Mafodotin in Myeloma
Posted: Friday, August 7, 2020
Belantamab mafodotin is a first-in-class maturation antigen-binding monoclonal immunoconjugate found to have clinical activity and an acceptable safety profile for treating patients with relapsed or refractory multiple myeloma in the DREAMM-2 trial. However, response was difficult to assess due to high expression of PD-1/PD-L1 in multiple myeloma cells. DREAMM-4 is the phase I/II follow-up study by Suzanne Trudel, MSc, MD, and colleagues at the Princess Margaret Cancer Centre, Ontario, Canada. Preliminary results were presented during the virtual edition of the 25th European Hematology Association (EHA) Annual Congress (EHA25 Virtual; Abstract EP955). Part 1 of this two-part, open-label trial found a tolerable safety profile and clinical activity for belantamab mafodotin, which warrants continued study.
The aim of DREAMM-4 was to further assess the tolerability, safety, and outcomes of belantamab mafodotin in conjunction with the PD-1 inhibitor pembrolizumab. Patients with refractory or relapsed multiple myeloma who had previously tried multiple lines of treatment were eligible for the trial. Part 1 of the study investigated dose escalation, with the goal of determining the recommended phase II dosage. Patients were given 2.5 kg or 3.4 kg of belantamab mafodotin with 200 mg of pembrolizumab every 3 weeks intravenously for a maximum of 35 cycles.
The study consisted of six patients in the low-dose group and seven in the higher-dose group. Although neither group experienced dose-limiting toxicities, adverse reactions were reported in all patients. Three patients in each group reported serious adverse effects. The most common adverse events included fatigue, dry eyes, blurry vision, or keratopathy. Patients in the low-dose group had an overall response rate of 67%, whereas patients in the high-dose group had an overall response rate of 14%.
The study is ongoing and currently in part 2. Its primary endpoint is to confirm the safety profile and determine the overall response rate.
Disclosure: For full disclosure of the study authors, visit library.ehaweb.org.
