Expanded use of Darzalex (daratumumab) in combination with standard therapy for treating adult patients with newly-diagnosed multiple myeloma, and who are not candidates for stem cell transplant, has been recommended by the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP).
The recommendation is based on results from the ALCYONE Phase 3 clinical trial (NCT02195479), which showed that adding Darzalex to standard therapy reduced the risk of disease progression or death by half. The EMA’s final decision is expected within two months.
“We are very pleased to receive this positive opinion from the CHMP, as it is an important step towards potentially bringing daratumumab to an expanded number of patients throughout Europe,” Jan van de Winkel, PhD, chief executive officer of Genmab, said in a press release.
Darzalex, created by Genmab, and developed and commercialized by Janssen Pharmaceuticals, is an antibody that targets and binds to a protein called CD38, which is present in high numbers on the surface of myeloma cells.
In patients who received at least one prior line of therapy, the addition of Darzalex to standard of care has reduced the risk of disease progression by more than 60%.
So, the ALCYONE trial set out to determine if Darzalex also could improve the outcomes of newly diagnosed myeloma patients who were unable to receive a stem cell transplant.
Participants received the treatment for nine cycles, each lasting five weeks. Patients in the Darzalex group continued to receive Darzalex as maintenance therapy until disease progression.
Darzalex reduced the risk for disease progression by half, researchers found, meeting the study’s primary goal.
An interim analysis, published in the New England Journal of Medicine, showed that while 71.6% of patients receiving Darzalex lived without signs of disease progression at 18 months, only 50.2% of patients receiving VMP did.
The combination also led to better response rates (90.9%), compared to VMP alone (73.9%). Complete responses or better were nearly were nearly double in the Darzalex arm — 42.6% versus 24.4%.
Minimal residual disease (cancer cells lingering in the body after treatment that often lead to relapse) was negative in more patients receiving Darzalex: 22.3% versus 6.2%.
Recently, the U.S. Food and Drug Administration approved Darzalex for a similar indication, also based on ALCYONE trial results.