Janssen’s Darzalex combo shows strong overall survival benefit at ASH 2019

pharmafile | December 10, 2019 | News story | Manufacturing and Production, Research and Development ASH 19, Janssen, darzalex, pharma 

Janssen has unveiled new Phase 3 data on the efficacy of Darzalex (daratumumab) when combined with bortezomib, melphalan and prednisone (D-VMP) in the treatment of newly diagnosed, transplant-ineligible multiple myeloma at the 2019 American Society of Hematology (ASH) Annual Meeting in Orlando.

In a pre-specified interim analysis conducted after a median follow-up of over three years, the Darzalex combo registered an estimated overall survival rate of 75% compared to 62% for bortezomib, melphalan and prednisone (VMP) alone.

After a median follow-up of 40.1 months, median progression-free survival for the combo stood at 36.4 months compared to 19.3 months with VMP alone, while MRD-negativity was recorded at 28% compared to 7%, respectively. Median OS was not assessed in either therapy regimen.

In separate data gathered in a follow-up of a median 36.4 months, Darzalex in combination with lenalidomide and dexamethasone was shown to reduce the risk of death or disease progression by at least 44%.

“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,” explained study investigator Dr Maria-Victoria Mateo, Director of the Myeloma Unit at University Hospital of Salamanca-IBSAL. “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.”

“The data we are presenting at ASH demonstrate the benefit of Datzalex-based regimens in the frontline setting as supported by deep, durable responses and significantly prolonged survival,” said Dr Yusri Elsayed, Vice President, Hematologic Malignancies Disease Area Leader at Janssen. “We remain committed to the study of Darzalex with the goal of making a difference in the lives of patients diagnosed with multiple myeloma.”

Matt Fellows

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