Opdivo plus Darzalex will be investigated in a new clinical trial.
Bristol-Myers Squibb recently announced a new clinical collaboration with Janssen to evaluate a combination treatment of Opdivo (nivolumab) plus Darzalex (daratumumab).
The immunotherapy and CD38-directed cytolytic antibody combination will be assessed in phase 1b/2 clinical trials in patients with multiple myeloma 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 multiple myeloma to include an Opdivo-Darzalex combination treatment arm. Additional similar studies will commence this year.
Opdivo is an immuno-oncology (I-O) human antibody that activates the immune system, and Darzalex 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, Darzalex is indicated as a monotherapy to treat patients with multiple myeloma 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 multiple myeloma 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.
Opdivo 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, Opdivo is indicated in combination with Yervoy (ipilimumab) 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 Opdivo 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 Opdivo plus the investigational drug CV301 in patients with non-small cell lung cancer. Additionally, Opdivo was supplied to Infinity Pharmaceuticals, who is investigating a combination of Opdivo 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.”