Darzalex daratumumab: Interim Phase III data

Interim data from the open-label, international Phase III POLLUX (MMY3003) trial in 569 patients with relapsed or refractory MM who received >=1 prior line of therapy showed that Darzalex plus Revlimid lenalidomide and dexamethasone met the primary endpoint of improving median PFS vs. Revlimid plus dexamethasone at a median follow-up of 13.5 months (not reached vs. 18.4 months, HR=0.37, 95% CI: 0.27, 0.52, p<0.0001). Darzalex plus Revlimid and dexamethasone also met the secondary endpoints of improving time to progression (not reached vs. 18.4 months, HR=0.34, 95% CI: 0.23, 0.48, p<0.0001), ORR (93% vs. 76%, p<0.0001) and the rate of VGPR or better (76% vs. 44%, p<0.0001) vs. Revlimid plus dexamethasone. Additionally, Darzalex plus Revlimid and dexamethasone improved the rate of complete response or better vs. Revlimid and dexamethasone (43% vs. 19%, p<0.0001). Median duration of response was not reached for Darzalex plus Revlimid and dexamethasone vs. 17.4 months for Revlimid plus dexamethasone. Patients received Revlimid plus dexamethasone or 16 mg/kg IV Darzalex once weekly for the first two 28-day treatment cycles, every 2 weeks during cycles 3-6 and once every 4 weeks from cycle 7 onwards plus Revlimid and dexamethasone. Data will be presented at the European Hematology Association meeting in Copenhagen in June (see BioCentury, April 4). ...