On Thursday, GSK plc GSK launched headline outcomes from a deliberate interim evaluation of the DREAMM-7 head-to-head part 3 trial of Blenrep (belantamab mafodotin) together with bortezomib plus dexamethasone (BorDex) as a second-line or later remedy for relapsed or refractory a number of myeloma.
The trial met the important thing secondary endpoint of general survival (OS), displaying that belantamab mafodotin when mixed with BorDex considerably lowered the danger of demise versus customary of care daratumumab plus BorDex.
The interim evaluation outcomes, together with security information, can be introduced on the upcoming American Society of Hematology Annual Assembly and Exposition.
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A part 3 research in newly recognized transplant-ineligible a number of myeloma is predicted to be initiated by the top of 2024 as a part of the DREAMM program.
In 2024, belantamab mafodotin mixtures have been filed within the U.S., European Union, Japan, United Kingdom, Canada, and Switzerland for relapsed or refractory a number of myeloma based mostly on the outcomes of the DREAMM-7 and DREAMM-8 trials.
In 2022, GSK withdrew the U.S. advertising and marketing authorization for Blenrep following the FDA request, based mostly on the beforehand introduced consequence of the DREAMM-3 Section 3 confirmatory trial, which didn’t meet the necessities of the FDA Accelerated Approval laws.
In June, GSK launched outcomes from an interim evaluation of the DREAMM-8 part 3 head-to-head trial of Blenrep together with pomalidomide plus dexamethasone (PomDex), versus an ordinary of care, bortezomib plus PomDex for relapsed or refractory a number of myeloma.
On the first endpoint of progression-free survival (PFS), the belantamab mafodotin mixture (n=155) confirmed a statistically important and clinically significant enchancment in comparison with the bortezomib mixture (n=147).
Worth Motion: GSK inventory is down 0.01% at $35.11 on the final verify on Thursday.
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