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GSK’s Blenrep Trips Up in Confirmatory Trial

November 9, 2022

GSK’s Blenrep (belantamab mafodotin), an antibody-drug conjugate that won accelerated approval in 2020, has failed its required confirmatory study as a treatment for relapsed or refractory multiple myeloma (RRMM), missing its primary endpoint.

In the trial, the average progression-free survival was longer in the Blenrep group (11.2 vs. 7 months) than the comparison drug combo, pomalidomide plus low-dose dexamethasone (Pom/Dex) but the difference wasn’t statistically significant.

Nor did the drug shine on its secondary endpoint of overall response rate (41 vs. 36 percent). The overall survival data aren’t mature yet, but so far don’t look encouraging: 21.2 months for Blenrep and 21.1 months for Pom/Dex.

But GSK isn’t giving up on the drug. “We remain confident in Blenrep and the potential to deliver meaningful results from combination trials in second-line relapsed/refractory multiple myeloma and in ongoing first-line evaluation,” the company said.

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