▎WuXiEdited by Kant Content Team

GSK today announced the interim analysis results of the Phase 3 DREAMM-8 head-to-head trial, which evaluates its antibody-drug conjugate (ADC) Blenrep (belantamab mafodotin) in combination with pomalidomide and dexamethasone (PomDex) versus the standard treatment of bortezomib plus PomDex for the efficacy and safety as a second-line and later therapy for relapsed or refractory multiple myeloma. The analysis shows,The trial met the primary endpoint of progression-free survival (PFS)., and unblinded early based on the recommendation of the Independent Data Monitoring Committee (IDMC).GSK will discuss these data with regulatory authorities.According to the press release, if approved, the combination therapy has the potential to redefine the treatment paradigm for relapsed or refractory multiple myeloma.

DREAMM-8 trial is a multicenter, open-label, randomized Phase 3 trial with 302 participants enrolled. Analysis shows that, compared with the standard treatment combination,Blenrep Combination Significantly Extends PFS, achieving the primary endpoint of the trial.A positive overall survival (OS) trend favoring the Blenrep combination was also observed during the analysis.The trial is still under continuous follow-up to observe changes in OS. Notably,The results of the DREAMM-8 trial are consistent with the efficacy outcomes observed for the Blenrep combination in another Phase 3 head-to-head trial, DREAMM-7.

The safety and tolerability of the Blenrep combination regimen are generally consistent with the known safety profiles of its individual components.

Blenrep is an ADC targeting B-cell maturation antigen (BCMA), composed of a humanized anti-BCMA monoclonal antibody and the cytotoxic drug auristatin F, conjugated via a non-cleavable linker.，which can eliminate myeloma cells through multiple mechanisms of action. The drug received Breakthrough Therapy Designation from the U.S. FDA in 2017 and obtained FDA approval in August 2020.Accelerated Approval``, becoming the world's first approved therapy targeting BCMA.``

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References:

[1] GSK announces positive results from DREAMM-8 phase III trial for Blenrep versus standard of care combination in relapsed/refractory multiple myeloma. Retrieved March 7, 2024 from https://www.gsk.com/en-gb/media/press-releases/gsk-announces-positive-results-from-dreamm-8-phase-iii-trial-for-blenrep-versus-standard-of-care-combination-in-relapsedrefractory-multiple-myeloma/

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