The Phase II trial did not meet its primary endpoint.
Five Prime Therapeutics took a hit after Bristol-Myers Squibb announced it has no near term plans for additional sponsored development of the company’s investigational asset cabiralizumab following a failure in a mid-stage pancreatic cancer trial.
Five Prime’s cabiralizumab was being paired with BMS’ checkpoint inhibitor Opdivo (nivolumab) with and without chemotherapy as a potential treatment for patients with advanced pancreatic cancer. The Phase II trial did not meet its primary endpoint. Cabiralizumab is an investigational inhibitor of 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 in the tumor microenvironment.
Bristol-Myers Squibb acquired rights to cabiralizumab in October 2015 under an exclusive worldwide license and collaboration agreement. With the failure of the Phase II trial, BMS said it has no near term plans for additional sponsored development of cabiralizumab, but will continue to support the evaluation of cabiralizumab in select, ongoing investigator-sponsored trials and may continue to assess future development opportunities, Five Prime said in its announcement.
The Phase II trial enrolled approximately 160 patients with locally advanced or metastatic pancreatic cancer that has progressed during or after one line of chemotherapy. Bristol-Myers Squibb also informed the company that no new safety signals were observed in the Phase II trial.
Pancreatic cancer is a difficult disease to treat and has the lowest survival rate of the most common cancers. Pancreatic cancer is the only major cancer with a single-digit five-year survival rate in nearly every country. Helen Collins, chief medical officer of Five Prime Therapeutics, said the company was disappointed that the combination of cabiralizumab and Opdivo with and without chemotherapy did not show any meaningful benefit over standard of care chemotherapy in pancreatic cancer patients.
For Five Prime, this was another blow to the company, which has had its share of struggles over the past two years. The company lost its chief executive officer and underwent two restructuring plans. When the company initiated its second restructuring in October 2019, Five Prime eliminated 70 jobs and reduce its corporate facilities footprint. In January 2019, the company eliminated 41 positions, about 20% of its staff, in a restructuring.
Still, there have been bright spots for the company, including an announcement this morning of a licensing deal with Seattle Genetics, which will develop and commercialize novel antibody-drug conjugate (ADC) therapies using monoclonal antibodies developed by Five Prime. ADCs harness the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells. Five Prime granted
Five Prime currently has five different programs in the clinic, with bemarituzumab being its most advanced asset. Bemarituzumab, a first-in-class isoform-selective antibody with enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) is in Phase III development as a targeted immunotherapy for tumors that overexpress FGFR2b.
