EMA Accepts GSK’s Blenrep MAA for Multiple Myeloma Review

The European Medicines Agency (EMA) has accepted GSK's marketing authorization application for Blenrep (belantamab mafodotin), a targeted antibody-drug conjugate (ADC), to treat patients with relapsed or refractory multiple myeloma (r/r MM). This ADC is designed to be used in combination with either bortezomib plus dexamethasone (BorDex) or pomalidomide plus dexamethasone (PomDex). The EMA’s Committee for Medicinal Products for Human Use (CHMP) will now begin the official review process of the application.

The submission of this marketing authorization is backed by interim data from the Phase III DREAMM-7 and DREAMM-8 clinical trials. The DREAMM-7 trial involved 494 participants who were randomized to receive the Blenrep combination or comparator drugs. In contrast, the DREAMM-8 trial included 302 participants, all of whom had previous exposure to lenalidomide, with a significant number showing refractoriness to the drug.

Results from these studies revealed notable improvements in progression-free survival (PFS) for the Blenrep combinations when compared to standard care, successfully meeting the primary endpoints of the trials. Specifically, the DREAMM-7 trial assessed the efficacy of Blenrep plus BorDex against daratumumab plus BorDex, while the DREAMM-8 trial evaluated Blenrep with PomDex against bortezomib plus PomDex.

While a positive trend in overall survival (OS) was noted, it had not reached statistical significance at the time of the interim analysis, and ongoing follow-up is required for OS. Additionally, the trials demonstrated improvements across various secondary efficacy endpoints, with the safety profile of Blenrep combinations being consistent with the known profiles of the individual agents involved.

Commenting on this significant milestone, GSK’s global head of oncology research and development and senior vice-president, Hesham Abdullah, emphasized the potential of Blenrep to transform outcomes for patients with multiple myeloma at or after the first relapse. Abdullah stated, “The milestone reinforces the potential for Blenrep to redefine outcomes for patients with multiple myeloma at or after first relapse. We are working to bring Blenrep to patients as quickly as possible given the high unmet need and the clinically robust effects of the Blenrep combinations in the DREAMM-7 and DREAMM-8 phase III head-to-head trials.”

This advancement follows GSK’s acquisition of Elsie Biotechnologies for $50 million, aimed at unlocking the potential of oligonucleotide therapeutics. The strategic acquisition is intended to bolster GSK's portfolio in innovative therapeutic solutions, further enhancing their commitment to addressing unmet medical needs in oncology and other critical fields.