Five Prime Therapeutics Cabiralizumab Plus Opdivo Fails Mid-stage Pancreatic Cancer Trial

Five Prime Therapeutics Cabiralizumab Plus Opdivo Fails Mid-stage Pancreatic Cancer Trial

Five Prime Therapeutics was informed by Bristol-Myers Squibb that the randomized phase 2 trial testing the combination of cabiralizumab with Opdivo (nivolumab) with and without chemotherapy in patients with advanced pancreatic cancer did not meet its primary endpoint.

Bristol-Myers Squibb acquired rights to cabiralizumab in October 2015 under an exclusive worldwide license and collaboration agreement. Based on the failure of the trial, BMS will not pursue additional sponsored development of cabiralizumab, but will continue to support the evaluation of cabiralizumab in select, ongoing investigator-sponsored trials. In addition, the company indicated future development opportunities may be explored.

The multi-arm, randomized, controlled phase 2 study  enrolled approximately 160 patients with locally advanced or metastatic pancreatic cancer that had progressed during or after one line of chemotherapy. The primary endpoint was median progression free survival (mPFS) up to 12 months using Response Evaluation Criteria in Solid Tumors (RECIST 1.1). 

About Cabiralizumab (FPA008) 

Cabiralizumab is an antibody that inhibits the CSF-1 receptor and has been shown in preclinical models and clinical studies to block the activation and survival of monocytes and macrophages. Inhibition of CSF1R in preclinical models of several cancers reduces the number of immunosuppressive tumor-associated macrophages (TAMs) in the tumor microenvironment, thereby facilitating an immune response against tumors. 

About Pancreatic Cancer

Pancreatic cancer begins in the tissues of the pancreas — an organ in the abdomen that lies behind the lower part of the stomach. Pancreatic cancer is seldom detected at its early stages when it’s most curable. This is because it often doesn’t cause symptoms until after it has spread to other organs. Thus, pancreatic cancer has the lowest survival rate of the most common cancers.