10 November 2017 - - New York, New York-based biopharmaceutical company Bristol-Myers Squibb (NYSE: BMY) and South San Francisco, California-based protein drug discovery specialist Five Prime Therapeutics, Inc. (NASDAQ: FPRX) have released preliminary results from a dose escalation and expansion study evaluating the safety, pharmacokinetics, and pharmacodynamics of cabiralizumab in combination with Opdivo (nivolumab) in patients with advanced solid tumors, the companies said.
This is the first disclosure of a clinical experience evaluating an anti-CSF-1 receptor antibody, which depletes immunosuppressive tumor associated macrophages, in combination with an anti-PD-1 antibody.
Preliminary results show that the safety profile of cabiralizumab plus Opdivo was generally consistent with that of Opdivo monotherapy, and that the combination results in dose-related decreases in circulating monocytes.
In a cohort of heavily pre-treated patients with advanced pancreatic cancer (n=31 evaluable patients), a patient population that is generally insensitive to immunotherapy, durable clinical benefit was observed in five patients, including confirmed objective responses in three patients with microsatellite-stable disease (objective response rate 10%).
Bristol-Myers Squibb and Five Prime are evaluating cabiralizumab in combination with Opdivo in a variety of advanced solid tumors.
Five Prime will continue to conduct the current Phase 1a/1b trial evaluating the combination of Opdivo and cabiralizumab in six tumor types. Bristol-Myers Squibb will be responsible for subsequent development studies and for global commercialization, and Five Prime will retain rights to a US co-promotion option.
Bristol-Myers Squibb discovers, develops, licenses, manufactures, markets, and distributes biopharmaceutical products worldwide.
The company offers chemically-synthesized drug and biologic in various therapeutic areas, such as oncology, cardiovascular, immunoscience, and virology comprising human immunodeficiency virus infection (HIV).
Five Prime Therapeutics discovers and develops therapeutics to improve the lives of patients with serious diseases.
The company's comprehensive extracellular protein discovery platform positions it to explore pathways in cancer, inflammation, and their intersection in immuno-oncology, an area of growing focus of the company's R and D activities.