Johnson & Johnson 's JNJ Janssen Research & Development announced that it has entered into a clinical trial collaboration agreement with Roche Holding AG's RHHBY Genentech under which the safety and tolerability of Janssen's Darzalex (daratumumab) will be evaluated in combination with Genentech's atezolizumab in a couple of early-stage studies.
The deal will see Janssen sponsor an open-label, multi-center phase Ib study that will evaluate Darzalex in combination with atezolizumab in patients with solid tumor. On the other hand, Genentech is the sponsor of an ongoing open-label, multicenter phase Ib study that will be amended to assess atezolizumab in combination with Darzalex, with Darzalex and Revlimid (lenalidomide), and with Darzalex and Pomalyst (pomalidomide) in patients with relapsed or refractory multiple myeloma.
These studies are expected to begin enrolling patients later this year. We note that Darzalex is the first CD38-directed monoclonal antibody while atezolizumab is an anti-PD-L1 antibody.
Darzalex had gained accelerated FDA approval in Nov 2015. It was approved for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.
We note that Amgen Inc.'s AMGN Kyprolis is also an approved drug for the treatment of multiple myeloma.
We remind investors that Johnson & Johnson's Janssen Biotech, Inc. had entered into a worldwide agreement with Genmab A/S GNMSF in Aug 2012, whereby the former was granted an exclusive license to develop, manufacture and commercialize Darzalex.
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