Date: 2015-09-08
Type of information: Treatment of the first patient
phase: 1
Announcement: treatment of the first patient
Company: Five Prime Therapeutics (USA - CA) BMS (USA - NY)
Product: FPA008 (cabiralizumab) and Opdivo® (nivolumab)
Action
mechanism: monoclonal antibody/immune checkpoint inhibitor/immunotherapy product. Opdivo® (nivolumab) is an investigational, fully-human PD-1 (programmed death-1) immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 expressed on activated T-cells. FPA008 is an antibody that inhibits colony stimulating factor-1 receptor (CSF1R). It blocks the activation and survival of monocytes and macrophages. Inhibition of CSF1R in inflamed RA joints blocks the production of inflammatory cytokines by macrophages and inhibits osteoclasts, monocyte-lineage cells that can cause bone erosions and joint destruction. Inhibition of CSF1R in many cancers reduces the number of immunosuppressive tumor-associated macrophages (TAMs), thereby facilitating an immune response against tumors.
Disease: non-small cell lung cancer, melanoma, head and neck squamous cell cancer, pancreatic cancer, colorectal cancer, glioblastoma multiforme
Therapeutic area: Cancer - Oncology
Country: USA
Trial
details: This is a phase 1a/b single arm , open-label, safety, tolerability, and PK study of FPA008 in combination with nivolumab and to evaluable clinical benefit at recommended dose of FPA008/nivolumab combination therapy in patient with selected, advanced cancers. (NCT02526017)
Latest
news: * On September 8, 2015, Five Prime Therapeutics announced that it has initiated patient dosing in the Phase 1a/1b clinical trial evaluating the immunotherapy combination of FPA008, Five Prime's monoclonal antibody that inhibits colony stimulating factor-1 receptor (CSF1R), with Opdivo® (nivolumab), BMS's PD-1 immune checkpoint inhibitor, in six tumor types. During Phase 1a, Five Prime will evaluate the safety, pharmacokinetics and biomarkers of escalating doses of FPA008 as a monotherapy, as well as in combination with the approved 3 mg/kg dose of nivolumab. Approximately 30 patients with advanced cancers are expected to be enrolled during the Phase 1a part of the study and both drugs will be administered every two weeks. In the Phase 1b part of the study, Five Prime will evaluate the safety, tolerability and preliminary efficacy of the selected dose of FPA008 in combination with nivolumab in approximately 240 patients, as a front-line therapy for melanoma; as second-line therapy for squamous cell carcinoma of the head and neck, pancreatic cancer, and malignant glioma; as a second- or third-line therapy for non-small cell lung cancer (NSCLC); and as a third-line therapy for colorectal cancer. Tumor biopsies will be obtained both pre-treatment and one month post-treatment in a subset of patients to analyze the immune response within the tumor microenvironment, and Five Prime will use this analysis to further guide FPA008's development in oncology. Under the terms of the clinical collaboration, BMS made a one-time payment of $30 million to Five Prime and is responsible for external study costs, the costs for Opdivo®, and half of the costs for FPA008 used in the Phase 1b part of the trial. The study design will be described in further detail in a trial-in-progress presentation at the International Cancer Immunotherapy Conference, to be held September 16-19, 2015 in New York City. Five Prime expects to complete Phase 1a dose escalation and expand into Phase 1b with the selected dose of FPA008 in late 2015 or early 2016. * On November 24, 2014, BMS and Five Prime Therapeutics announced that they have entered into an exclusive clinical collaboration agreement to evaluate the safety, tolerability and preliminary efficacy of combining Opdivo® (nivolumab) with FPA008, Five Prime’s monoclonal antibody that inhibits colony stimulating factor-1 receptor (CSF1R). The Phase 1a/1b study will 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.
