Manufacturer Collaboration Will Evaluate Opdivo Plus Darzalex Across Multiple Cancer Types

Combination therapy to be assessed in multiple myeloma and solid cancers.

Bristol-Myers Squibb recently announced a new clinical collaboration with Janssen to evaluate a combination treatment of nivolumab (Opdivo) plus daratumumab (Darzalex).

The immunotherapy and CD38-directed cytolytic antibody combination will be assessed in phase 1b/2 clinical trials in patients with multiple myeloma (MM) and solid cancers, such as non-small cell lung cancer, pancreatic cancer, colorectal cancer, triple-negative breast cancer, and head and neck cancer, according to a press release from Bristol-Myers Squibb.

Last year, Bristol-Myers Squibb expanded a phase 1 clinical trial for MM to include an nivolumab-daratumumab combination treatment arm. Additional similar studies will commence this year.

Nivolumab is an immuno-oncology (I-O) human antibody that activates the immune system, and daratumumab is a cytolytic antibody that may induce cancer cell death through immune-mediated mechanisms of action, and can also target immuno-suppressive cells in the tumor, according to the press release.

Both companies believe that a combination therapy will increase the anti-cancer activity of both drugs.

Currently, daratumumab is indicated as a monotherapy to treat patients with MM who have undergone at least 3 prior treatments, including a proteasome inhibitor and an immunomodulatory agent. It is indicated as a combination therapy to treat patients with MM who received at least 1 previous treatment, Bristol-Myers Squibb reported.

Opdivo was the first PD-1 immune checkpoint inhibitor to be approved by the FDA, and has since been approved in more than 57 countries, including Japan, and Europe.

Nivolumab is indicated as a monotherapy in patients with various types of melanoma, renal cell carcinoma, metastatic non-small cell lung cancer, classical non-Hodgkin lymphoma, and squamous cell carcinoma of the head and neck. As a combination therapy, nivolumab is indicated in combination with ipilimumab (Yervoy) for the treatment of unresectable or metastatic melanoma.

This new agreement builds on a previous collaboration between Bristol-Myers Squibb and Janssen created in 2016, which evaluated nivolumab in combination with an investigational drug created by Janssen in patients with non-small cell lung cancer, according to the press release.

Bristol-Myers Squibb has also entered into drug supply agreements with Bavarian Nordic to investigate the use of nivolumab plus the investigational drug CV301 in patients with non-small cell lung cancer. Additionally, nivolumab was supplied to Infinity Pharmaceuticals, who is investigating a combination of nivolumab plus the investigational drug IPI-549 in patients with advanced solid tumors.

“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,” said Fouad Namouni, MD, head of Development, Oncology at 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.”