Janssen and Genmab will not proceed to evaluate daratumumab as a treatment for non-Hodgkin’s lymphoma since it missed the efficacy endpoint in Phase II.
Janssen has an exclusive worldwide license to develop Genmab’s daratumumab, approved in the US and Europe as Darzalex for the treatment of multiple myeloma (MM) indications. As the first monoclonal antibody to be approved by the FDA to treat MM, Janssen expected it to bring up to a massive €12Bn ($13Bn) a year.
However, this figure is subject to the approval of the drug for several blood cancer indications. Results of the first stage of a Phase II trial have revealed that the drug failed to reach response rates of 50% and 30% for follicular lymphoma and diffuse large B-cell lymphoma, respectively. Consequently, the team has decided to halt the second stage of the trial, which eliminates two of the antibody’s indications from the list.
This clinical failure comes just weeks after MorphoSys added a new patent to its lawsuit against Janssen and Genmab for the ownership of the IP behind their potential blockbuster. MorphoSys is developing an antibody with the same target as daratumumab, the CD38 antigen. This molecule is present in the surface of cancer cells from a range of blood tumor types, making it a highly valuable target.
The trial is scheduled for August 2018, and, meanwhile, Janssen seems determined to make the most of the drug. Although Darzalex was only approved for its first indication at the end of 2015, it has already given Janssen an impressive €535M ($572M) in revenues in 2016. The results of its remaining ongoing trials will determine whether the drug meets the blockbuster expectations.
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