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# GSK Blenrep Phase 3 Misses Primary Endpoint
- URL: https://www.fdaweb.com/gsk-blenrep-phase-3-misses-primary-endpoint/
- Published: 2022-11-07T12:00:00.000Z
- Updated: 2026-09-14T18:05:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153140

GSK says a Phase 3 trial involving its accelerated-approved Blenrep (belantamab mafodotin) in patients with relapsed or refractory multiple myeloma (RRMM) did not meet its primary endpoint of progression-free survival (PFS). The therapy was earlier granted accelerated approval in 2020 as a monotherapy for treating adult patients with RRMM who have received at least four prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent ([see earlier story](https://www.fdaweb.com/fda-oks-glaxo-myeloma-therapy/)). Approval then was based on the results of the DREAMM-2 clinical trial on overall response rate and duration of response, and it was contingent upon a confirmed clinical benefit from a randomized Phase 3 clinical trial.

In the latest Phase 3 trial (DREAMM-3), Blenrep versus pomalidomide in combination with low dose dexamethasone (PomDex) was studied in an open-label, randomized head-to-head superiority trial design. While Blenrep did not meet the PFS endpoint, the company did note median PFS was longer in patients treated with the therapy versus PomDex (11.2 months vs 7 months). “At the time of the primary analysis, the OS \[overall survival\] data had only achieved 37.5% overall maturity,” it says adding that the median OS was 21.2 and 21.1 months for belantamab mafodotin and PomDex, respectively.

Data from DREAMM-3 is being shared with health authorities and discussions are currently ongoing, GSK says.