Exelixis Provides Update on Phase 3 CONTACT-03 Trial Evaluating Cabozantinib in Combination with Atezolizumab in Patients with Previously Treated Advanced Kidney Cancer
Exelixis, Inc. today 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.
About RCC
Kidney cancer is among the top ten most commonly diagnosed forms of cancer among both men and women in the U.S.1 An estimated 81,800 Americans will be diagnosed with kidney cancer in 2023.1 Clear cell RCC is the most common type of kidney cancer in adults.2 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 14%.3 In 2022, approximately 32,200 patients with advanced kidney cancer required systemic therapy in the U.S., with over 20,000 patients receiving first-line treatment.4
About CABOMETYX® (cabozantinib)
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 Pharma SAS 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 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.
CABOMETYX in combination with atezolizumab is not indicated as a treatment for RCC.
About Exelixis
Exelixis is a globally ambitious oncology company innovating next-generation medicines and regimens at the forefront of cancer care. Powered by bi-coastal centers of discovery and development excellence, we are rapidly evolving our product portfolio to target an expanding range of tumor types and indications with our clinically differentiated pipeline of small molecules, antibody drug conjugates and other biotherapeutics. This comprehensive approach harnesses decades of robust investment in our science and partnerships to advance our investigational programs and extend the impact of our flagship commercial product, CABOMETYX® (cabozantinib). Exelixis is driven by a bold scientific pursuit to create transformational treatments that give more patients hope for the future. For information about the company and its mission to help cancer patients recover stronger and live longer, visit www.exelixis.com, follow @ExelixisInc on Twitter, like Exelixis, Inc. on Facebook and follow Exelixis on LinkedIn.
Published on Friday, 03 March 2023
