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Bristol-Myers, Five Prime to evaluate nivolumab and FPA008 combination in six tumor types

Bristol-Myers Squibb (BMS) and Five Prime Therapeutics have entered into an exclusive clinical collaboration agreement to evaluate safety, tolerability and preliminary efficacy of the combination of Opdivo (nivolumab) and FPA008 in six tumor types.

Opdivo is BMS’s investigational PD-1 (programmed death-1) immune checkpoint inhibitor, while FPA008 is Five Prime’s monoclonal antibody that inhibits colony stimulating factor-1 receptor (CSF1R).

As part of the deal, BMS will make a one-time payment of $30m to Five Prime and will be responsible for study costs, while Five Prime will oversee the clinical trial, which is scheduled to commence in 2015.

A Phase Ia/IIb trial will be conducted to evaluate the combination of Opdivo and FPA008 as a potential treatment option for patients with non-small cell lung cancer (NSCLC), melanoma, head and neck cancer, pancreatic cancer, colorectal cancer and malignant glioma.

Both Opdivo and FPA008 are part of a new class of cancer treatments known as immunotherapies and are designed to harness the body’s own immune system to combat cancer.

Bristol-Myers Squibb senior vice-president and head of Development, Oncology Michael Giordano said: "This collaboration supports our strategy to expand the clinical development of Opdivo, including novel combination regimens and across numerous tumour types.

"We are excited to build upon our existing relationship with Five Prime Therapeutics in immuno-oncology, and explore the full potential of Opdivo and FPA008 in multiple tumour types."

In Japan, Opdivo is approved to treat patients with unresectable melanoma and is being developed in multiple tumour types in more than 50 clinical trials.