Belantamab Mafodotin Met Primary Endpoint for Those with Relapsed, Refractory Multiple Myeloma

Belantamab mafodotin (Blenrep; GlaxoSmithKline) met the primary endpoint of progression-free survival (PFS) as a second line treatment for relapsed or refractory (R/R) multiple myeloma (MM), demonstrating that when combined with bortezomib and dexamethasone (BorDex) the time to disease progression or death was extended compared to the standard of care, according to results from the DREAMM-7 study.¹

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“Patients with multiple myeloma need treatment options after first relapse that are efficacious, readily accessible, and have novel mechanisms of action. We are particularly encouraged by the potential for belantamab mafodotin when combined with BorDex to address high unmet need in [R/R MM], given the head-to-head comparison with the daratumumab-based standard of care regimen,” Hesham Abdullah, MD, MSc, senior vice president of Global Head Oncology Research and Development at GSK said in s statement.¹

According to data from the National Library of Medicine, multiple myeloma makes up 1.8% of all new cancer cases and contributes to 2.1% of deaths every year in the United States, with an incidence of approximately 4.5 to 6 per 100,000 annually. Since 1990, the incidence has increased by over 40% in the United States and 126% globally, according to the authors. Although the mortality has increased by approximately 94% globally, the authors reported that mortality has decreased by 15% in the United States, with the 5-year survival rate more than doubling within the past few decades.²

The authors also said that most patients with MM respond to first line therapy; however, most will relapse. They added that treatment plans for each patient should be highly individualized.²

The DREAMM-7 study was a phase 3 clinical trial to evaluate the safety and efficacy of belantamab mafodotin in combination with BorDex compared to the standard-of-care combination, including daratumumab and BorDex for patients with R/R MM that had been treated with at least 1 prior line of therapy. A total of 494 individuals were randomized 1:1 to receive either the investigational combination, including 2.5 mg/kg of belantamab mafodotin every 3 weeks intravenously, or the standard of care. The primary endpoint was PFS with key secondary endpoints of overall survival (OS), duration of response, and minimal residual disease negativity rate, according to the press release.¹

Investigators found a clinically meaningful trend of OS observed at the time of this analysis, with investigators continuing to follow up for final data on OS. The safety and tolerability for the regimen were consistent with the known safety of each individual agent. The results from the interim analysis will be presented at an upcoming scientific meeting and will be shared with health authorities, according to the press release.¹

The study is part of the DREAMM clinical development program that evaluates the potential of belantamab mafodotin in early lines of treatment as well as combinations with standard-of-care treatments and novel therapies. DREAMM-8 will be a phase 3 trial that evaluates belantamab mafodotin in combination with pomalidomide and dexamethasone compared to bortezomib with pomalidomide and dexamethasone. Investigators expect data in the second half of 2024, according to the press release.¹

References

1. GSK announces positive results from DREAMM-7 head-to-head phase III trial for Blenrep in relapsed/refractory multiple myeloma. News release. GSK. November 27, 2023. Accessed November 27, 2023. https://www.gsk.com/en-gb/media/press-releases/gsk-announces-positive-results-from-dreamm-7-head-to-head-phase-iii-trial-for-blenrep/
2. Ahmed A, Killeen RB. Relapsed and Refractory Multiple Myeloma. [Updated 2023 Jun 8]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK592405/