Collaboration to evaluate Opdivo in combination with Darzalex

The combination of Opdivo (nivolumab) and CD38-directed cytolytic antibody Darzalex (daratumumab) is being evaluated in Phase Ib/II clinical studies in multiple myeloma and solid tumors including non-small cell lung cancer (NSCLC), pancreatic cancer, colorectal cancer (CRC), triple negative breast cancer and head and neck cancer.

In 2016 an existing Bristol-Myers Squibb (NYSE: BMY) Phase I study was expanded to include the combination of its immuno-oncology (I-O) Opdivo and Darzalex, from US healthcare giant Johnson & Johnson’s (NYSE: JNJ) subsidiary Janssen Biotech, 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 by targeting immuno-suppressive cells in the tumor microenvironment. The combination of these agents may enhance immune-mediated killing of tumors. 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 in combination with other agents for the treatment of patients with multiple myeloma who have received at least one prior therapy.