Exelixis: Cabozantinib data shows treatment well tolerated, 'promising'
Exelixis announced results from a phase 1 trial of cabozantinib in combination with either nivolumab or nivolumab plus ipilimumab in patients with refractory genitourinary tumors. The primary endpoint of the trial is to determine the dose limiting toxicity and recommended phase 2 doses of the doublet and triplet combinations. The findings were presented during a poster session on February 17 at the 2017 Genitourinary Cancers Symposium, which is being held in Orlando, Florida, February 16-18, 2017. "There is a significant unmet need for treatment regimens that can slow tumor progression in advanced, intractable cancers such as metastatic urothelial carcinoma. The use of combination therapies may be a strategy that could increase anti-tumor activity in these patients," said Andrea Apolo, M.D., Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, the principal investigator of the trial. "Previously reported data from Part I of the trial showed that cabozantinib in combination with nivolumab provided an encouraging objective response rate and tolerability profile across a diverse range of genitourinary tumors. Data from Part II also demonstrate that using cabozantinib with two immunotherapy agents is well-tolerated with promising early activity. These results support the further evaluation of both regimens in these tumor types." The recommended doses for the ongoing expansion cohorts were determined to be cabozantinib 40 mg daily plus nivolumab 3 mg/kg once every 2 weeks for the doublet and cabozantinib 40 mg daily, nivolumab 3 mg/kg plus ipilimumab 1 mg/kg every 3 weeks for 4 doses, then nivolumab 3 mg/kg every 2 weeks for the triplet. "These early clinical results generated by our collaborators at the NCI-CTEP suggest that the combination of cabozantinib with either nivolumab or nivolumab and ipilimumab in patients with genitourinary malignancies is associated with an encouraging tolerability, safety and activity profile," said Michael M. Morrissey, Ph.D., president and Chief Executive Officer of Exelixis. "With these results in hand, we are committed to further examining the potential of cabozantinib in combination with a variety of immunotherapies to treat a broad range of genitourinary and other cancers."