GSK Plc: DREAMM-3 Phase III Trial For Blenrep Fails To Meet Primary Endpoint

(RTTNews) - GSK plc (GSK.L, GSK) announced the DREAMM-3, the phase III head-to-head superiority trial of Blenrep monotherapy versus pomalidomide in combination with low dose dexamethasone in patients with relapsed or refractory multiple myeloma, did not meet its primary endpoint of progression-free survival. The safety and tolerability profile of belantamab mafodotin was consistent with the known safety profile, the company noted.

Blenrep was granted accelerated approval by the FDA as a monotherapy for treating adult patients with refractory multiple myeloma who have received at least four prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent. The accelerated approval was based on the results of the DREAMM-2 overall response rate, duration of response and contingent upon a confirmed clinical benefit from a randomised phase III trial.

The Group noted that additional trials within the DREAMM clinical trial programme will continue.

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