JNJ - J&J's daratumumab extends survival in first-line multiple myeloma

Genmab A/S (GMAB) announces positive results from the second part of a Phase 3 clinical trial, CASSIOPEIA, evaluating daratumumab as maintenance treatment versus no treatment in newly diagnosed multiple myeloma ((MM)) patients who are eligible for autologous stem cell transplantation.Part 2, conducted by the French Intergroupe Francophone du Myelome in collaboration with the Dutch-Belgian Cooperative Trial Group for Hematology Oncology and and Janssen Research & Development, LLC, a unit of Johnson & Johnson (JNJ), met the primary endpoint of progression-free survival at a pre-planned interim analysis with 47% less risk of cancer progression or death (hazard ratio = 0.53).The independent Data Monitoring Committee has recommended unblinding the data.Licensee Janssen Biotech plans to discuss the submission of marketing applications for the indication with health authorities.Daratumumab, marketed by Janssen under the brand name Darzalex, was first approved in the U.S. in November 2015 for previously treated MM patients.

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J&J's daratumumab extends survival in first-line multiple myeloma