Exelixis, Inc. announced that enrollment is complete for CONTACT-03, the global, phase 3 pivotal trial evaluating the efficacy and safety of 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 following treatment with an immune checkpoint inhibitor (ICI) as the immediate preceding line of therapy. CONTACT-03 is a global, multicenter, randomized, phase 3, open-label study that enrolled 523 patients who were randomized 1:1 to the experimental arm of cabozantinib in combination with atezolizumab and the control arm of cabozantinib alone. The primary endpoints of the trial are progression-free survival per Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1 as assessed by independent radiology review and overall survival.

Secondary endpoints include progression-free survival, objective response rate and duration of response as assessed by the investigators. CONTACT-03 is sponsored by Roche and co-funded by Exelixis. The design of CONTACT-03 was informed by the ongoing COSMIC-021 trial — a phase 1b study of cabozantinib in combination with atezolizumab in multiple advanced solid tumors including RCC, non-small cell lung cancer and castration-resistant prostate cancer.

The American Cancer Society's 2021 statistics cite kidney cancer as among the top ten most commonly diagnosed forms of cancer among both men and women in the U.S. Clear cell RCC is the most common form of kidney cancer in adults. If detected in its early stages, the five-year survival rate for RCC is high; for patients with advanced or late-stage metastatic RCC, however, the five-year survival rate is only 13%. Approximately 32,000 patients in the U.S. and 71,000 worldwide will require systemic treatment for advanced kidney cancer in 2021.

In the U.S., CABOMETYX tablets are approved for the treatment of patients with advanced RCC; for the treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib; for patients with advanced RCC as a first-line treatment in combination with nivolumab; and for adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer that has progressed following prior VEGFR-targeted therapy and who are radioactive iodine-refractory or ineligible. CABOMETYX tablets have also received regulatory approvals in the European Union and additional countries and regions worldwide. In 2016, Exelixis granted Ipsen exclusive rights for the commercialization and further clinical development of cabozantinib outside of the U.S. and Japan.

In 2017, Exelixis granted exclusive rights to Takeda Pharmaceutical Company Limited for the commercialization and further clinical development of cabozantinib for all future indications in Japan. Exelixis holds the exclusive rights to develop and commercialize cabozantinib in the U.S.