ASH 2024 – GSK's Blenrep Dreamm gets better
If there was any doubt about the return of GSK’s Blenrep, the company hammered its message home at ASH on Monday with overall survival data from the Dreamm-7 trial. In second-line or later multiple myeloma, the study found a 42% decrease in the risk of death with Blenrep plus bortezomib and dexamethasone, versus Darzalex plus bortezomib and dexamethasone, with a p value of 0.00023. The BMCA-targeting ADC originally got accelerated approval for late-line use in 2020, but was withdrawn in 2023 after failure of the confirmatory Dreamm-3 trial; GSK has already refiled based on Dreamm-7 and 8, and expects an FDA approval decision by 23 July 2025. And the UK group has started the long-awaited pivotal front-line Dreamm-10 pivotal study. Still, the multiple myeloma landscape is changing rapidly, with Johnson & Johnson and Legend’s Carvykti recently approved in second-line disease, J&J attempting to move its anti-BCMA T-cell engager Tecvayli into the front line, and also taking aim at a disease precursor with Darzalex. In such a competitive arena, Blenrep’s known eye toxicity could become a focus, but in Dreamm-7 ocular issues were generally resolved with dose modifications, GSK said. Still, these side effects led to a 10% discontinuation rate.
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