Janssen has announced EC marketing authorisation for Darzalex® (daratumumab) in combination with lenalidomide and dexamethasone (DRd) for the treatment of newly diagnosed multiple myeloma patients who are ineligible for autologous stem cell transplant (ASCT).
The approval was based on results from the Phase III MAIA (MMY3008) study, published in The New England Journal of Medicine earlier this year and presented at the American Society of Hematology (ASH) Annual Meeting in 2018.
“Despite recent therapeutic advances, relapse of multiple myeloma is considered to be almost inevitable, becoming more challenging to treat following each relapse. This makes it even more important that we maximise our best response upfront to extend the first remission,” said Professor Thierry Facon, MD, Service des Maladies du Sang, Hôspital Claude Huriez, Lille, France, and principal investigator of the MAIA study. “This marks an important approval, especially for transplant ineligible patients, a more vulnerable population, for whom outcomes are generally poorer when compared to those who are transplant eligible.”
The study included 737 newly diagnosed patients with multiple myeloma ineligible for high-dose chemotherapy and ASCT aged 45-90 years old (median age of 73 years). Daratumumab in combination with Rd significantly reduced the risk of disease progression or death by 44% in patients with newly diagnosed multiple myeloma who are transplant ineligible, compared to treatment with Rd alone (hazard ratio [HR] = 0.56; 95% confidence interval [CI]: 0.43-0.73; p<0.0001). At median follow-up of 28.0 months the median progression-free survival (PFS) for daratumumab-Rd had not yet been reached, compared to 31.9 months for patients who received Rd alone. The addition of daratumumab resulted in deeper responses compared to Rd alone, including increased rates of complete response (CR) or better (48% vs. 25%) and improved rates of very good partial response (VGPR) or better (79% vs. 53%). Daratumumab-Rd induced a >3-fold higher rate of minimal residual disease (MRD) negativity compared to those who received Rd alone (24% vs. 7%).
“Every year over 48,000 people in Europe are diagnosed with multiple myeloma, which is considered to be incurable. Older patients who are ineligible for transplant have a limited range of frontline therapeutic options available, so we are pleased that with today’s approval of daratumumab-Rd, these patients now have a new frontline option available to them,” said Dr Patrick Laroche, Haematology Therapy Area Lead, Europe, Middle East and Africa (EMEA), Janssen-Cilag.
Craig Tendler, MD, Vice President, Clinical Development and Global Medical Affairs, Oncology, Janssen Research & Development, LLC., commented: “It’s gratifying to see that through our research and development efforts, daratumumab has helped over 100,000 patients globally. With today’s approval and the continued development of daratumumab, we hope to bring this innovative therapy to many more patients in the future.”