Darzalex is a CD38-directed antibody, which has already been approved in the some geographies for certain previously treated multiple myeloma patient groups. Credit: KGH via Wikimedia.

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.

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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.

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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.