Daratumumab monotherapy Phase I/II trial for refractory multiple myeloma published in NEJM- Genmab + Janssen Biotech

Genmab A/S announced the New England Journal of Medicine (NEJM) has published the full data set from the initial Phase I/II study with daratumumab monotherapy treating patients with relapsed or refractory multiple myeloma. Patients that received 16 mg/kg in part two of the study had a median of four prior lines of therapy and 64% of these patients were refractory to both proteasome inhibitors (PIs) and immunomodulatory (IMiD) drugs, which are current standard of care treatments for multiple myeloma.

The data showed a 36% response rate in the 16 mg/kg group in part two of the study, with responses that deepened over time. Sixty five percent of patients in this group that responded to treatment were progression-free twelve months after the start of treatment. For all patients in part two, pneumonia and thrombocytopenia were the most common grade 3/4 adverse events. Infusion-related reactions were mild with no dose-dependent adverse events. In part one of the study, no maximum tolerated dose was identified up to 24 mg/kg. Following this study, 16 mg/kg was chosen as the dose to be used in future daratumumab clinical studies.

Daratumumab is being developed by Janssen Biotech under an exclusive worldwide license from Genmab to develop, manufacture and commercialise daratumumab. Data from this study has been included in the Biologics License Application (BLA) submitted by Janssen to the FDA for daratumumab as a treatment for patients with multiple myeloma who have received at least three prior lines of therapy including both a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) or who are double refractory to a PI and an IMiD. The BLA submission was completed on July 9th 2015.

See- Targeting CD38 with Daratumumab Monotherapy in Multiple Myeloma-Henk M. Lokhorst, Torben Plesner, Jacob P. Laubach, et al. DOI:10.1056/NEJMoa1506348.