Big Dreamms for GSK

Dreamm-10, the pivotal study of GSK's Blenrep in first-line multiple myeloma that had once been expected to start in 2021, is finally here. New listings on the clinicaltrials.gov registry have revealed this study for the first time, confirming that Blenrep will go head to head against Darzalex, and citing start of patient enrolment on 28 November. That's quite the turnaround for Blenrep, an anti-BCMA ADC with a rollercoaster past: the drug was approved on an accelerated basis for late-line multiple myeloma but was withdrawn when the confirmatory Dreamm-3 trial failed, before two second-line studies, Dreamm-7 and 8, yielded unexpectedly positive results. On the basis of Dreamm-7 and 8 GSK wants US and EU regulators to reinstate Blenrep's approval. Moving to start Dreamm-10 hints that GSK thinks its chances of Blenrep's reinstatement are high, but Johnson & Johnson/Legend's Carvykti, plus other multiple myeloma drugs, are making the recruitment of patients into front-line studies difficult. Already this changing treatment landscape has claimed one victim: in September Bristol Myers Squibb and 2seventy bio scrapped Karmma-9, their first-line multiple myeloma phase 3 trial of Abecma, citing “considerably fewer eligible patients than when the study was first designed”.

Dreamm-10 summary

Source: OncologyPipeline.