Credit: Linda Bartlett
Single-agent daratumumab can elicit responses in patients with multiple myeloma (MM) who have failed treatment with proteasome inhibitors and immunomodulatory agents (IMiDs), preliminary results of a phase 2 study suggest.
The study enrolled MM patients who have received at least 3 different lines of therapy, including both a proteasome inhibitor and an IMiD, and patients who are double-refractory to a proteasome inhibitor and an IMiD.
Daratumumab, an anti-CD38 monoclonal antibody, has breakthrough therapy designation from the US Food and Drug Administration to treat this patient population.
Genmab A/S, the company that discovered daratumumab and licensed it to Janssen Biotech, Inc. for development, announced results from the phase 2 trial (Sirius MMY2002) yesterday.
This 2-part study enrolled 124 MM patients. The goal of part 1 was to define an optimal daratumumab regimen going forward, and part 2 was an expansion based on the optimal regimen.
Patients were randomized to receive daratumumab at 8 mg/kg every 4 weeks continuously by intravenous infusion or at 16 mg/kg administered at weekly intervals for 8 weeks, then every 2 weeks for an additional 16 weeks, and every 4 weeks thereafter by intravenous infusion.
Genmab reported that the overall response rate was 29.2% in the 16 mg/kg dosing group. And the median duration of response was 7.4 months, as determined by an independent review committee.
Daratumumab also showed a manageable safety profile, according to Genmab. The company said the data will be discussed with health authorities at upcoming meetings, pending their agreement.
