On September 18, 2015 Five Prime Therapeutics, Inc. (Nasdaq:FPRX), a clinical-stage biotechnology company focused on discovering and developing novel protein therapeutics for cancer and inflammatory diseases, reported that the Phase 1a/1b clinical trial combining FPA008 with OPDIVO (nivolumab) in multiple tumor types was featured today in a trial-in-progress poster at the CRI-CIMT-EATI-AACR Inaugural International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) in New York City (Press release, Five Prime Therapeutics, SEP 18, 2015, View Source [SID:1234507502]). FPA008 is Five Prime’s monoclonal antibody that inhibits colony stimulating factor-1 receptor (CSF1R). OPDIVO is Bristol-Myers Squibb’s PD-1 immune checkpoint inhibitor. The poster entitled "A Phase 1a/1b Study of FPA008 in Combination with Nivolumab in Patients with Selected Advanced Cancers" was presented by F. Stephen Hodi, Jr., M.D., of Dana-Farber Cancer Institute.
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The comprehensive design of the study, which is being conducted by Five Prime under a clinical collaboration with Bristol-Myers Squibb, will allow the company to explore the potential of FPA008 in immuno-oncology, both as a monotherapy and in combination with anti-PD-1 therapy. During Phase 1a, Five Prime will evaluate the safety, pharmacokinetics and biomarkers of escalating doses of FPA008 alone, and in combination with the approved 3 mg/kg dose of nivolumab. Approximately 30 patients with advanced cancers are expected to be enrolled during Phase 1a and both drugs will be administered every two weeks. In Phase 1b, Five Prime will evaluate the safety, tolerability and preliminary efficacy of the selected dose of FPA008 in combination with nivolumab in approximately 240 patients across eight tumor settings:
Second- or third-line non-small cell lung cancer (NSCLC, anti PD-1 therapy naïve)
Anti PD-1 therapy resistant NSCLC (either de novo or acquired)
Previously untreated melanoma (anti PD1 therapy naïve)
Anti PD-1 therapy resistant melanoma (de novo)
Second-line squamous cell carcinoma of the head and neck
Second-line pancreatic cancer
Third-line colorectal cancer
Second-line glioblastoma multiforme (GBM)
Tumor biopsies will be obtained both pre-treatment and one month post-treatment in all patients enrolled in the Phase 1a portion and in a subset of patients enrolled in the Phase 1b portion to analyze the immune response within the tumor microenvironment. Five Prime will use this analysis to further guide FPA008’s development in oncology.
"We are pleased to now have patient dosing underway and to be evaluating the FPA008/nivolumab immunotherapy combination in the original six tumor settings we’ve communicated, as well as in two additional settings, anti-PD1 resistant non-small cell lung cancer and melanoma," said Julie Hambleton, M.D., Executive Vice President and Chief Medical Officer of Five Prime. "We remain on track to complete Phase 1a dose escalation and expand into Phase 1b across the eight tumor settings in late 2015 or early 2016."
About FPA008
FPA008, Five Prime’s antibody that inhibits colony stimulating factor-1 receptor (CSF1R), targets macrophages and monocytes, which are activated or elevated in multiple disease settings. In cancer, tumor-associated macrophages suppress the immune system’s ability to kill cancer cells. In joint diseases, such as PVNS and RA, synovial macrophages play a central role in the disease process. Five Prime is evaluating the immunotherapy combination of FPA008 and OPDIVO (nivolumab), Bristol-Myers Squibb’s investigational PD-1 immune checkpoint inhibitor, in six tumor types in a Phase 1a/1b clinical trial. Five Prime is also conducting a Phase 1/2 trial of FPA008 in pigmented villonodular synovitis (PVNS), a joint tumor driven by the CSF1 pathway and an orphan disease, and a Phase 1 study in rheumatoid arthritis.