BMS, Janssen in Immunotherapy Pact
Bristol-Myers Squibb (BMS) has formed a new clinical research collaboration with Janssen Biotech, a Johnson & Johnson company, to evaluate the combination of BMS’s immuno-oncology agent, Opdivo (nivolumab), and Janssen’s CD38-directed cytolytic antibody, Darzalex (daratumumab), in Phase Ib/II clinical studies in cancer indications. The companies are studying the drug combination in multiple myeloma and solid tumors, including non-small-cell lung cancer, pancreatic cancer, colorectal cancer, triple negative breast cancer and head and neck cancer.
In 2016, an existing BMS Phase I study was expanded to include the combination of Opdivo and Darzalex in multiple myeloma; this study is ongoing. Additional studies will start in 2017.
Opdivo is a human antibody designed to alleviate immune suppression. Darzalex is a cytolytic antibody believed to induce tumor cell death through multiple immune-mediated mechanisms of action and also demonstrates immunomodulatory activities. The combination of these agents may enhance immune-mediated killing of tumors, according to the companies.
Darzalex is indicated as a monotherapy for 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 immunomodulatory agent. It is also approved in combination with other agents for the treatment of patients with multiple myeloma who have received at least one prior therapy. Janssen licensed daratumumab, the active ingredient in Darzalex, from Genmab in August 2012 and is responsible for all global development, marketing, and manufacturing. The drug is commercialized in the US by Janssen.
Opdivo urrently has regulatory approval in 57 countries including the US, Japan, and in the European Union for various cancer indications. The drug had 2015 sales of $942 million.
This agreement builds off BMS and Janssen’s previous clinical research collaboration announced in July 2016 to evaluate Opdivo and Janssen’s live attenuated double–deleted Listerial monocytogenes cancer immunotherapy in patients with non-small cell lung cancer.