Darzalex “significantly reduces” disease progression and death in multiple myeloma at ASH 2018

Janssen has taken the opportunity at the American Society of Hematology (ASH) Annual Meeting 2018 to unveil new Phase 3 data for its combination of Darzalex (daratumumab) alongside lenalidomide and dexamethasone (Rd) in the treatment of newly diagnosed multiple myeloma in patients who are ineligible for autologous stem cell transplant (ASCT).

The findings showed that the combo "significantly reduced" the risk of disease progression or death; at a median follow-up of 28 months, patients experienced a reduction of 44% compared to Rd alone. Median progression-free survival (PFS) stood at 31.9 months for Rd alone, but PFS for the Darzalex combo has not yet been reached. However, the combo recorded a rate of complete response or better at 48% compared to 25% for Rd alone, while partial response was measured at 79% versus 53%.

"The Phase 3 MAIA study reinforces the clinical profile of daratumumab in combination with a standard of care treatment regimen for newly diagnosed patients with multiple myeloma who are transplant ineligible," remarked Dr Thierry Facon, Service des Maladies du Sang, Hôpital Claude Huriez and principal investigator on the study. "The positive data show the potential role of daratumumab in combination with lenalidomide and dexamethasone as an important new therapeutic approach for this patient population."

Dr Yusri Elsayed, Vice President, Hematologic Malignancies Disease Area Leader at Janssen R&D, added: "These data underscore the consistent clinical profile observed among newly diagnosed patients with multiple myeloma receiving Darzalex therapy, including for those who are transplant ineligible. This is the third study in newly diagnosed patients that has met its primary endpoint, showing Darzalex continues to provide strong evidence of clinical benefit in combination with standard of care regimens in the treatment of multiple myeloma."

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