Subcutaneous daratumumab: Ph Ib data

Data from 41 evaluable patients with relapsed or refractory MM in the dose-escalation part 1 of the open-label, international Phase Ib PAVO trial showed that once-weekly 1,200 and 1,800 mg doses of subcutaneous daratumumab for cycles 1-2, every 2 weeks in cycles 3-6 and every 4 weeks thereafter was well tolerated and led to serum trough concentrations similar to or greater than that of IV Darzalex daratumumab over a significantly shorter infusion time. Subcutaneous daratumumab also had a lower rate of infusion-related reactions (22% vs. the 46% reported on Darzalex's U.S. label). All infusion-related reactions developed during or within 6 hours of the first infusion of subcutaneous daratumumab.

In 8 evaluable patients, 1,200 mg subcutaneous daratumumab infused over 20 minutes led to an ORR of 25%, including 2 partial responses. Median time to response was 14 weeks. In 17 evaluable patients, 1,800 mg subcutaneous daratumumab infused over 30 minutes led to an ORR of 41%, including 3 very good partial responses and 4 partial responses. Median time to response was 4 weeks. Genmab said it selected 1,800 mg as the recommended Phase II dose for part 2 of the trial. Data will be presented at the American Society of Hematology meeting in San Diego next month...