Johnson & Johnson subsidiary Janssen has presented promising results from two Phase III trials of Darzalex (daratumumab) in newly diagnosed multiple myeloma patients who are ineligible for surgery or high-dose chemotherapy.
In the Phase III Alcyone study, Darzalex combined with bortezomib, melphalan and prednisone (VMP) improved the overall survival (OS) of patients. After more than three years of follow-up, Darzalex combined with VMP (D-VMP) showed an estimated 42 month OS rate of 75%, compared to 62% for VMP alone.
The D-VMP combination also caused statistically significant higher rates of minimal residual disease negativity of 28%, compared to 7% for VMP alone. As well as causing higher median progression-free survival of 36.4 months versus 19.3 months for VMP after a median 40.1 months of follow-up.
Alcyone study investigator and Salamanca-IBSAL University Hospital Myeloma unit director Maria-Victoria Mateos said: “As a physician treating patients with multiple myeloma, I want to achieve the deepest response in the frontline setting to hopefully provide long-term benefit.
“This longer follow-up from the ALCYONE study is encouraging because we see that adding daratumumab to VMP in the frontline setting can provide an important overall survival advantage compared with a current standard of care.”
Similar positive results were also observed in the Phase III Maia study of Darzalex, combined with lenalidomide and dexamethasone (Rd). The combination caused a maximum 44% reduction in the risk of disease progression or death in newly diagnosed multiple myeloma patients ineligible for surgery or chemotherapy, compared to Rd alone.
These results were presented at the American Society of Hematology (ASH)’s Annual Meeting in Orlando, Florida. Data from the Alcyone study were also published in The Lancet.
Janssen vice-president and haematologic malignancies disease area leader Yusri Elsayed said: “The data we are presenting at ASH demonstrate the benefit of Darzalex-based regimens in the frontline setting as supported by deep, durable responses and significantly prolonged survival.
“We remain committed to the study of Darzalex with the goal of making a difference in the lives of patients diagnosed with multiple myeloma.”
Darzalex is a CD38-directed antibody, which has already been approved in the some geographies for certain previously treated multiple myeloma patient groups as both a monotherapy and a combination therapy.