Janssen Reports Positive Results for DARZALEX® in Multiple Myeloma

Janssen Reports Positive Results for DARZALEX® in Multiple Myeloma

December 13, 2019PAO-M12-19-NI-006

The only CD38-directed antibody showed an overall survival benefit and improvement in progression-free survival.

Multiple myeloma is a blood cancer that results in damaged plasma cells in bone marrow, leading to the development of tumors. Approximately 30,000 people are expected to be diagnosed and nearly 13,000 to have died in 2019 due to this incurable disease.

Janssen Pharmaceutical Companies of Johnson & Johnson is developing DARZALEX® (daratumumab), the first CD38-directed monoclonal antibody (mAb) approved to treat multiple myeloma. Daratumumab binds to CD38 surface proteins on multiple myeloma cells, causing cell death and inhibiting tumor growth. The drug was initially developed by Genmab A/S, which granted Janssen Biotech an exclusive license to develop, manufacture, and commercialize DARZALEX® in 2012.

In the United States, the drug received FDA approval in 2015 as a monotherapy for patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent, or who are double refractory to a PI and an immunomodulatory agent. It also received approval in combination with various drugs for the treatment of patients that have received at least one or more prior therapies, and in 2018 became the first mAb (in combination with bortezomib, melphalan, and prednisone) approved for the treatment of patients with newly diagnosed multiple myeloma.

Janssen recently reported on longer follow-up results of a phase III trial for DARZALEX® in combination with bortezomib, melphalan, and prednisone (D-VMP) for the treatment of newly diagnosed, transplant-ineligible multiple myeloma patients. Improved overall survival was observed, with a 40% reduction in the risk of death compared with VMP alone. Higher rates of minimal residual disease (MRD) negativity were also obtained.

The results indicate that adding daratumumab to VMP in the frontline setting can provide an important overall survival advantage compared with a current standard of care, according to Maria-Victoria Mateos, M.D., Ph.D., Director of the Myeloma Unit at University Hospital of Salamanca-IBSAL, Salamanca, Spain, and a study investigator.


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