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Wednesday, October 21, 2020

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

  • Genmab A/S (NASDAQ: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 (NYSE: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.
  • https://seekingalpha.com/news/3624549-j-and-js-daratumumab-extends-survival-in-first-line-multiple-myeloma

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