Genmab's Darzalex heading for first-line in multiple myeloma
- In a pre-planned interim analysis of the Phase 3 ALCYONE study, Darzalex in combination with Velcade, melphalan and prednisone (VMP), met the primary endpoint in 706 patients receiving first-line treatment for multiple myeloma.
- The Darzalex combination reduced the risk of disease progression or death by 50% compared with VMP alone, and the median progression-free survival for the combination had not been met at this point, compared with 18.1 months for VMP alone.
- An independent data monitoring committee recommended unblinding, and Janssen Biotech will discuss the potential for submission with regulatory authorities.
Getting first-line approval will be a boost for both Genmab, the original developer of the drug, and Johnson & Johnson's Janssen Biotech, its worldwide licensee. The two companies have been working together since 2012.
Success will also put Darzalex (daratumumab) ahead of Amgen's Kyprolis (carfilzomib), which did not meet its endpoints in a comparison with VMP in first-line mulitple myeloma in a Phase 3 trial reported last September.
Darzalex won early approval in November 2015 for heavily pre-treated multiple myeloma, four months ahead of its target decision date from the Food and Drug Administration.
European approval followed in May 2016, but the drug may not get recommendation from the U.K.'s National Institute for Health and Care Excellence (NICE). It also has breakthrough designation for second-line treatment of the blood cancer, and has been approved in the U.S. in combination with pomalidomide and dexamethasone in second line.
"The interim results of the ALCYONE study yet again illustrate the potential of daratumumab in multiple myeloma in combination with existing treatment regimens; this time with VMP in the front line setting," said Jan van de Winkel, CEO of Genmab.
Darzalex is also in development for solid tumors, and in other malignant and pre-malignant diseases in which CD38 is expressed, such as smoldering myeloma. Earlier this year, Janssen Biotech dropped Darzalex in relapsed or refractory non-Hodgkin's lymphoma (NHL) after the failure of the CARINA Phase 2 study. A data review showed that the study didn't meet the endpoints for relapsed or refractory follicular lymphoma or diffuse large B-cell lymphoma, and couldn't recruit enough patients in mantle cell lymphoma.
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