Darzalex OK’d to Treat Multiple Myeloma Patients in Japan Not Eligible for Stem Cell Transplant

People in Japan newly diagnosed with multiple myeloma and ineligible for a stem cell transplant can now use a combination of Darzalex (daratumumab) and standard treatment, the companies behind the therapy announced.

The approval, by the country’s Ministry of Health, Labor and Welfare, was based on data from the ALCYONE Phase 3 trial (NCT02195479), where the addition of Darzalex to standard treatment — Velcade (bortezomib), melphalan, and prednisone (VMP) — cut by half the risk of disease worsening or death compared to VMP alone.

Results from this trial also led the U.S. Food and Drug Administration and European Medicines Agency to approve the combination for the same patient group.

Darzalex, created by Genmab, and developed and commercialized by Janssen Pharmaceuticals, is an antibody that targets and binds the CD38 protein, present in high numbers on the surface of myeloma cells, regardless of disease severity. By binding CD38, Darzalex works to kill cancer cells directly and to also trigger an immune response that helps to destroy the cancer.

ALCYONE tested the benefits of Darzalex as an add-on to standard VMP treatment in newly diagnosed multiple myeloma patients who could not receive an autologous (patient-derived) stem cell transplant.

This type of transplant uses a patient’s own blood stem cells, which are harvested before the person is given high-dose chemotherapy. The harvested cells are then transplanted to replenish the bone marrow and create healthy blood cells.

In the trial, 706 people received nine, five-week cycles of VMP with or without Darzalex. Patients in the investigative group then continued to receive Darzalex as a maintenance therapy until study’s end or evidence of disease progression.

After 18 months of treatment, 71.6% of patients using Darzalex remained alive and disease-free compared to 50.2% of those given VMP alone — representing a 50% reduction in the risk of disease worsening or death.

Response rates also were significantly higher in the Darzalex group (90.9%) compared to the VMP only group (73.9%). Complete responses nearly doubled with the Darzalex combo — 42.6% vs. 24.4%.

Serious side effects were more frequently reported in patients on Darzalex (42%) compared to standard treatment (33%), with the most common being pneumonia.

Darzalex is the first human monoclonal antibody that binds CD38 to enter the market in the United States, Europe and Japan, Genmab announced in a press release.

“Multiple myeloma remains one of the most common forms of blood cancer in Japan and as such, we are encouraged that patients in Japan newly diagnosed with this disease now have the option to receive a Darzalex containing regimen,” said Jan van de Winkel, chief executive officer of Genmab.