Janssen reports positive trial data for new multiple myeloma therapy

Janssen has announced the publication of new data from an early-stage trial assessing their developmental multiple myeloma therapy daratumumab.

Published in the New England Journal of Medicine, the trial showed that the investigational human anti-CD38 monoclonal antibody demonstrated a tolerable safety profile as a monotherapy in patients with multiple myeloma who had relapsed after or were refractory (resistant) to at least two or more prior lines of therapy. 

The drug also demonstrated a 36 percent overall response rate in patients treated with a 16 mg/kg dose, with responses improving over time.

Dr Peter Lebowitz, global oncology head at Janssen, said: "We are confident in our comprehensive development plan for daratumumab, which includes studying the medicine in earlier lines of therapy, both as a single agent and in combination with existing therapies."

Janssen completed a rolling submission of a biologic licence application for daratumumab to the US Food and Drug Administration in July 2015.

The therapy was licensed from Genmab as part of an agreement signed in August 2012.