Exelixis Provides Update on Phase 3 CONTACT-03 Trial Evaluating Cabozantinib in Combination with Atezolizumab in Patients with Previously Treated Advanced Kidney Cancer

Reno, Nevada (UroToday.com) -- Exelixis, Inc. announced that the phase 3 CONTACT-03 study did not meet its primary endpoint of progression-free survival (PFS). CONTACT-03 evaluated cabozantinib (CABOMETYX®) in combination with atezolizumab versus cabozantinib alone in patients with locally advanced or metastatic clear cell or non-clear cell (papillary or unclassified only) renal cell carcinoma (RCC) who progressed during or after immune checkpoint inhibitor therapy (either combination or monotherapy).

The safety profile of the combination of cabozantinib and atezolizumab observed in the trial was consistent with the known safety profiles for each single agent, and no new safety signals were identified with the combination.

Detailed findings will be presented at an upcoming medical meeting.

About CONTACT-03

CONTACT-03 is a global, multicenter, randomized, phase 3, open-label study that enrolled 522 patients who were randomized 1:1 to the experimental arm of cabozantinib in combination with atezolizumab and the control arm of cabozantinib alone. There is limited data available to suggest the optimal treatment for these patients and CONTACT-03 was initiated in the hope of defining the clinical benefit of the combination of a multi-tyrosine kinase inhibitor and an immune checkpoint inhibitor following progression. The primary endpoints of the trial are PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1 as assessed by independent radiology review and overall survival. Key secondary endpoints include PFS, objective response rate and duration of response as assessed by the investigators. CONTACT-03 is sponsored by Roche and co-funded by Exelixis. More information about CONTACT-03 is available at ClinicalTrials.gov. 

Source: Exelixis, Inc. 2023. Exelixis Provides Update on Phase 3 CONTACT-03 Trial Evaluating Cabozantinib in Combination with Atezolizumab in Patients with Previously Treated Advanced Kidney Cancer [Press release]. https://ir.exelixis.com/news-releases/news-release-details/exelixis-provides-update-phase-3-contact-03-trial-evaluating.