GSK plots Blenrep’s path back to market with EU filing
GSK plots Blenrep’s path back to market with EU filing
GSK on Friday announced that the European Medicines Agency has accepted its marketing authorization application for Blenrep (belantamab mafodotin), as part of a combination regimen, for the treatment of relapsed or refractory multiple myeloma.
The company is proposing to use Blenrep with either bortezomib plus dexamethasone (BorDex) or pomalidomide plus dexamethasone (PomDex). The European Medicines Agency (EMA) has accepted the application and its Committee for Medicinal Products for Human Use will now begin its formal review of the combo regimen before making a final recommendation to the European Commission.
Hesham Abdullah, global head of oncology R&D at GSK, in a statement called the EMA’s acceptance of its application a “milestone” that “reinforces the potential for Blenrep to redefine outcomes for patients with multiple myeloma at or after first relapse.”
GSK is backing Blenrep’s EMA bid with data from the Phase III DREAMM-7 and DREAMM-8 studies, which showed that both Blenrep-based combos resulted in “statistically significant and clinically meaningful improvements” in progression-free survival (PFS), while demonstrating positive interim trends for overall survival.
Both studies also showed that the Blenrep regimens hit their secondary endpoints, inducing deep and durable responses. DREAMM-7 and DREAMM-8 continue to follow patients for overall survival data.
Blenrep is an antibody-drug conjugate that targets the B-cell maturation agent, which is a protein commonly overexpressed in multiple myeloma. It carries a cytotoxic auristatin F agent that when released inside cancer cells triggers its death.
The FDA granted Blenrep accelerated approval in August 2020 as a monotherapy for relapsed or refractory multiple myeloma, under the condition that GSK would validate its clinical benefit in a confirmatory Phase III trial. However, in November 2022, Blenrep failed the Phase III DREAMM-3 trial, unable to significantly improve PFS versus pomalidomide.
Shortly after, GSK decided to pull Blenrep from the U.S. market.
Last month, emboldened by newer data from other DREAMM-7 and DREAMM-8, GSK unveiled plans to relaunch Blenrep and touted its “multi-blockbuster” potential in an investor event.
The company is seeking to carve out a niche for Blenrep in second-line multiple myeloma. DREAMM-7, which used the BorDex combination, established Blenrep’s superiority to Johnson & Johnson’s Darzalex (daratumumab) while DREAMM-8 showed that Blenrep could outperform Takeda’s Velcade (bortezomib).
During last month’s investor event, Chief Commercial Officer Luke Miels said that these data could help Blenrep achieve peak sales of $3 billion and eventually replace Darzalex as the standard of care in the second-line care setting for multiple myeloma.
Source: BioSpace
