BMS Announces Immunotherapy with Janssen to Evaluate Opdivo, Darzalex Combo

Bristol-Myers Squibb Company announced a new clinical research collaboration with Janssen Biotech, Inc. to evaluate the combination of Bristol-Myers Squibb’s Immuno-Oncology (I-O) agent Opdivo and Janssen’s CD38-directed cytolytic antibody Darzalex in Phase 1b/2 clinical studies in multiple myeloma and solid tumors including non-small cell lung cancer, pancreatic cancer, colorectal cancer (CRC), triple negative breast cancer and head and neck cancer. In 2016 an existing Bristol-Myers Squibb 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 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.

“We continue to explore innovative I-O combination therapies to accelerate the discovery of new treatment options that harness the immune system to fight cancer and deliver benefits to patients,” says Fouad Namouni, M.D., head of Development, Oncology, Bristol-Myers Squibb. “Our collaboration with Janssen will leverage the expertise of both organizations to rapidly evolve the science and treatments of both hematologic and solid tumors.”

Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world in July 2014, and currently has regulatory approval in 57 countries including the United States, Japan, and in the European Union.

This agreement builds off Bristol-Myers Squibb and Janssen’s previous clinical research collaboration announced in July, 2016 to evaluate Opdivo and Janssen’s Live Attenuated Double–Deleted (LADD) Listerial monocytogenes cancer immunotherapy, expressing mesothelin and EGFRvIII (JNJ-64041757), in patients with non-small cell lung cancer.