Darzalex Add-on Delays Disease Progression or Death in Newly Diagnosed Multiple Myeloma, Phase 3 Trial Shows

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by Alice Melão |

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Treatment with Darzalex (daratumumab) plus standard Revlimid (lenalidomide) and dexamethasone significantly delays the time to disease progression or death in newly diagnosed multiple myeloma patients who are not eligible for high-dose chemotherapy and stem cell transplant, a Phase 3 trial showed.

The trial compared the triple combo to treatment with Revlimid plus dexamethasone alone. Darzalex reduced the risk of death or disease progression by 45%.

The interim analysis was conducted by an independent data monitoring committee which, in light of the positive results, recommended trial continuation to examine survival and long-term safety.

“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],” Jan van de Winkel, PhD, CEO of Genmab, said in a press release. “As such, this data increases our hope that daratumumab may one day help even more patients at the outset of treatment of this disease.”

Darzalex is an antibody that targets CD38, a surface molecule widely produced by myeloma cells. The treatment, initially discovered by Genmab and later licensed to Janssen Biotech, is already approved for multiple myeloma indications, including a combination with the immunomodulatory drug Revlimid and the corticosteroid dexamethasone for patients who have received at least one prior therapy.

Also, the treatment was recently approved in the U.S. and Europe, in combination with Velcade (bortezomib), melphalan, and prednisone, for patients with newly diagnosed myeloma unable to receive a stem cell transplant.

The MAIA Phase 3 trial (NCT02252172) was now designed to determine whether adding Darzalex to Revlimid and dexamethasone could also improve the outcomes of multiple myeloma patients who had not had any prior treatment and were not eligible for a stem cell transplant.

The study included 737 patients who were randomly assigned Revlimid plus dexamethasone, either with or without Darzalex. Patients came from more than 210 clinical centers across North America, Europe, Australia, and Israel.

Darzalex was given every week for the first eight weeks, every other week for 16 weeks, and every four weeks thereafter until disease progression or safety issues appeared. Revlimid was administered daily three weeks on, one week off, and dexamethasone was administered once weekly.

According to the recent data, the study’s primary goal has been reached, with patients on Darzalex living significantly longer without signs of disease worsening than those on standard treatment.

The combination has also been well-tolerated, consistent with the safety profiles of Darzalex and the Revlimid-dexamethasone combo seen in prior reports.

Janssen is planning to discuss a label extension for this indication with health authorities. It also plans to present MAIA’s results at a medical conference or in a peer-reviewed publication.