Europe sinks Blenrep

The EU regulator's CHMP has recommended against renewing the conditional approval of GSK's Blenrep, an anti-BCMA antibody-drug conjugate, in relapsed/refractory multiple myeloma. Blenrep was granted conditional approval in August 2020 for treating patients who had received at least four prior therapies including an anti-CD38 MAb, a proteasome inhibitor and an immunomodulatory drug, based on Phase II Dreamm-2 trial. However, in November 2022 Dreamm-3 failed to meet its primary endpoint of PFS, yielding a hazard ratio of 1.03 versus Pomalyst plus dexamethasone. GSK has separately been told by the FDA to withdraw Blenrep from the US market, also based on the Dreamm-3 failure. However, the phase 3 Dreamm-7 and 8 trials in second-line multiple myeloma are continuing, with data readouts expected by the end of this year.