GSK Raises Prospects For Withdrawn Blood Cancer Drug Blenrep To Return To US Market - Here's Why

On Thursday, GSK plc GSK released headline results from a planned interim analysis of the DREAMM-7 head-to-head phase 3 trial of Blenrep (belantamab mafodotin) in combination with bortezomib plus dexamethasone (BorDex) as a second-line or later treatment for relapsed or refractory multiple myeloma.

The trial met the key secondary endpoint of overall survival (OS), showing that belantamab mafodotin when combined with BorDex significantly reduced the risk of death versus standard of care daratumumab plus BorDex.

The interim analysis results, including safety data, will be presented at the upcoming American Society of Hematology Annual Meeting and Exposition.

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A phase 3 study in newly diagnosed transplant-ineligible multiple myeloma is expected to be initiated by the end of 2024 as part of the DREAMM program.

In 2024, belantamab mafodotin combinations have been filed in the U.S., European Union, Japan, United Kingdom, Canada, and Switzerland for relapsed or refractory multiple myeloma based on the results of the DREAMM-7 and DREAMM-8 trials.

In 2022, GSK withdrew the U.S. marketing authorization for Blenrep following the FDA request, based on the previously announced outcome of the DREAMM-3 Phase 3 confirmatory trial, which did not meet the requirements of the FDA Accelerated Approval regulations. 

In June, GSK released results from an interim analysis of the DREAMM-8 phase 3 head-to-head trial of Blenrep in combination with pomalidomide plus dexamethasone (PomDex), versus a standard of care, bortezomib plus PomDex for relapsed or refractory multiple myeloma.

On the primary endpoint of progression-free survival (PFS), the belantamab mafodotin combination (n=155) showed a statistically significant and clinically meaningful improvement compared to the bortezomib combination (n=147).

Price Action: GSK stock is down 0.01% at $35.11 at the last check on Thursday.

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