This article is more than 5 years old. Information may no longer be current.
Frontline daratumumab regimen extends PFS in multiple myeloma
A randomized phase 3 trial to evaluate the addition of daratumumab to lenalidomide and dexamethasone for the frontline treatment of patients with multiple myeloma met its primary endpoint of PFS, according to the agent’s manufacturer.
The MAIA study included 737 patients newly diagnosed with myeloma who were not candidates for high-dose chemotherapy and autologous stem cell transplant.
Researchers randomly assigned patients to the immunomodulatory drug lenalidomide (Revlimid, Celgene) plus dexamethasone with or without daratumumab (Darzalex; Janssen, Genmab), a human monoclonal antibody that targets CD38.
Lenalidomide was dosed at 25 mg orally on days 1 through 21 of each 28-day cycle, and dexamethasone was administered at 40 mg weekly.
Patients assigned daratumumab received 16 mg/kg weekly for the first 8 weeks, followed by every other week for 16 weeks and every 4 weeks thereafter.
Treatment continued until disease progression or unacceptable toxicity.
Results of a preplanned interim analysis showed the daratumumab regimen significantly improved PFS (median, not reached vs. 31.9 months; HR = 0.55; 95% 0.43-0.72).
The safety profile of daratumumab in combination with lenalidomide and dexamethasone appeared consistent with the agents’ known safety profiles.
Officials with Janssen — which licensed daratumumab from Genmab in 2012 — intend to discuss the possibility of a regulatory submission for this indication with health authorities, and data will be submitted for presentation at a future medical conference or publication in a peer-reviewed journal, according to a press release.
“We are highly encouraged by this data, as this is the fifth randomized study showing a profound benefit when adding daratumumab to standard-of-care treatments in multiple myeloma, and the second showing efficacy for patients with newly diagnosed multiple myeloma who are not eligible for [autologous stem cell transplant]. As such, this data increases our hope that daratumumab may one day help even more patients at the outset of treatment of this disease,” Jan van de Winkel, PhD, CEO of Genmab, said in the release.