ASH18: Johnson & Johnson, Genmab's Darzalex cuts risk of disease progression, death by 44 percent in newly diagnosed multiple myeloma study

In late-stage study data presented Tuesday at the American Society of Hematology (ASH) annual meeting, the addition of Johnson & Johnson and Genmab's Darzalex (daratumumab) to Celgene's Revlimid (lenalidomide) and dexamethasone significantly lowered the risk of disease progression or death in patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation. In October, Genmab said that the MAIA study hit its main goal, with the regimen containing Darzalex significantly reducing the risk of progression or death. 

In the study, 737 newly diagnosed patients with multiple myeloma ineligible for high-dose chemotherapy or autologous stem cell transplantation were assigned to treatment with Darzalex plus Revlimid and dexamethasone or Revlimid and dexamethasone alone in 28-day cycles. 

Results detailed on Tuesday showed that at a median follow-up of 28 months, the Darzalex combination significantly reduced the risk of disease progression or death by 44 percent compared to treatment with Revlimid and dexamethasone alone. The companies noted that median progression-free survival for Darzalex has not yet been reached, compared to 31.9 months for patients who received Revlimid and dexamethasone alone. 

Yusri Elsayed, hematologic malignancies disease area leader at Johnson & Johnson's Janssen Research & Development unit, stated "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." Johnson & Johnson noted that results from the study will support a regulatory filing in the US seeking approval of Darzalex for use in patients with newly diagnosed multiple myeloma. 

The therapy was initially authorised by the FDA in 2015 for the treatment of multiple myeloma in patients who received at least three prior treatments.  

Darzalex was jointly developed by Johnson & Johnson and Genmab under the terms of a 2012 partnership. Sales of the drug in the quarter ended September 30 jumped 57.1 percent to $498 million versus the year-ago period. 

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