GSK multiple myeloma drug’s DREAMM comeback continues with phase 3 data at ASH

CAR-T Digest - August 2020

09 Dec 2024: GSK multiple myeloma drug’s DREAMM comeback continues with phase 3 data at ASH

GSK’s Blenrep extended progression-free survival (36.6 months vs. 13.4 months) and duration of response (40.8 months vs. 19.4 months) compared to J&J’s Darzalex-based regimen, with potential to become a standard treatment for relapsed/refractory multiple myeloma
The FDA is evaluating Blenrep’s Phase 3 data for potential market re-entry, with a decision expected by July 2024. Regulatory reviews are also ongoing in six other markets
Blenrep offers an off-the-shelf option compared to BCMA-targeting CAR T-cell therapies like Abecma and Carvykti, which require specialized infrastructure and extended manufacturing time
Blenrep’s ocular toxicity (black box warning) led to manageable side effects with a 10% discontinuation rate in DREAMM-7, managed through dose adjustments
Blenrep could compete against multiple myeloma market leaders like Darzalex and newer BCMA-targeting therapies, with potential peak sales of £3 billion (~$3.8 billion)
GSK is exploring frontline use of Blenrep with ongoing Phase 1 trials to optimize dosing and combinations, aiming for broader approval and improved tolerability