The New England Journal of Medicine has published the full dataset from Danish biotech company Genmab (OMX: GEN) on its Phase I/II study with daratumumab monotherapy in relapsed or refractory multiple myeloma.
The data showed a 36% response rate in the 16 mg/kg group in part 2 of the study, with responses that deepened over time, and 65% of patients in this group that responded to treatment were progression-free twelve months following the start of treatment. Patients receiving 16mg/kg had a median of four prior lines of therapy, and 64% of these patients were refractory to protease inhibitors and immunomodulatory drugs, which are the current standard of care treatments for multiple myeloma.
The 16mg/kg dose was chosen as the dose to be used in future daratumumab trials. The drug is being developed by Janssen Biotech, a unit of Johnson & Johnson (NYSE: JNJ), under an exclusive license from Genmab.
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