Exelixis presents final overall survival results from Phase 3 CONTACT-02 study

Exelixis announced detailed final overall survival results from CONTACT-02, a phase 3 pivotal study evaluating cabozantinib in combination with atezolizumab compared with a second novel hormonal therapy in patients with metastatic castration-resistant prostate cancer and measurable extra-pelvic soft tissue disease who have progressed on one prior NHT. The two primary endpoints for CONTACT-02 were progression-free survival and OS. At a median follow-up of 24.0 months, the final analysis of OS showed a numerical but not statistically significant improvement favoring cabozantinib in combination with atezolizumab. An improvement in OS was observed in multiple clinical subgroups, notably in patients with bone or liver metastases, with the latter category representing a population whose disease may be evolving away from androgen receptor signaling. Treatment-related grade 3-4 adverse events occurred in 40% of patients receiving cabozantinib in combination with atezolizumab and 8% of those receiving NHT. Treatment-related AEs leading to discontinuation of all treatment components were similar. The time to clinically meaningful deterioration in quality of life was similar between arms, and the combination of cabozantinib and atezolizumab did not impair quality of life relative to generally well-tolerated NHT. As previously announced, CONTACT-02 met one of its two primary endpoints, demonstrating a statistically significant benefit in PFS in the predefined PFS ITT population.