Exelixis: Updated Phase 1 results for cabozanitinib combo shows 42% ORR
Exelixis announced updated data from expansion cohorts in 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 will be presented during a poster session on February 9 at the 2018 American Society of Clinical Oncology Genitourinary Cancers Symposium, which is being held in San Francisco, California, February 8-10, 2018. The updated data reported results from 78 patients treated with cabozantinib and nivolumab with or without ipilimumab. The initial part of the study determined the recommended dose for each treatment at four dose levels. In all, 49 patients were treated with the doublet combination of cabozantinib and nivolumab and 29 patients were treated with the triplet combination of cabozantinib, nivolumab and ipilimumab. Nineteen patients with mUC were evaluable for response with a median follow up of 15.7 months. Thirteen patients with previously treated mRCC were evaluable for response. For the mUC cohort, the ORR across all treatment groups was 42 percent and the DCR was 84 percent. Seven of eight mUC patients with an objective response had not progressed at the time of the data cut-off. Median PFS in this patient population was 12.8 months and the overall survival rate at 12 months was 77 percent. Among the 13 patients with mRCC who were evaluable for response, ORR was 54 percent and the DCR was 100 percent.