– Initiation follows positive results from cohort 6 of phase 1b COSMIC-021 trial –
– CONTACT-02 is the second of three phase 3 pivotal trials that are part of a clinical collaboration with Roche –
ALAMEDA, Calif.--(BUSINESS WIRE)-- Exelixis, Inc. (NASDAQ: EXEL) today announced the initiation of CONTACT-02, a global phase 3 pivotal trial of cabozantinib (CABOMETYX®) in combination with atezolizumab (TECENTRIQ®) in patients with metastatic castration-resistant prostate cancer (CRPC) who have been previously treated with one novel hormonal therapy. CONTACT-02 is part of a clinical trial collaboration between Exelixis and Roche that includes two additional phase 3 pivotal trials – CONTACT-01 in patients with metastatic non-small cell lung cancer (NSCLC) who have been previously treated with an immune checkpoint inhibitor and platinum-containing chemotherapy, which was initiated in June, and the planned CONTACT-03 trial in patients with metastatic renal cell carcinoma (RCC) who previously received an immune checkpoint inhibitor.
“As many patients with advanced, castration-resistant prostate cancer who have progressed on a novel hormonal therapy wish to avoid or delay chemotherapy, more treatment options are needed,” said Gisela Schwab, M.D., President, Product Development and Medical Affairs and Chief Medical Officer, Exelixis. “We are encouraged by the positive early stage results for the combination of cabozantinib and atezolizumab seen for prostate cancer patients in cohort 6 of the COSMIC-021 trial, and we are pleased to begin this pivotal trial that will further evaluate how the combination may improve outcomes for these patients as part of our ongoing partnership with Roche.”
CONTACT-02 is a global, multicenter, randomized, phase 3, open-label study that plans to enroll approximately 580 patients at 250 sites. Patients will be randomized 1:1 to the experimental arm of cabozantinib in combination with atezolizumab and the control arm of a second novel hormonal therapy (either abiraterone and prednisone or enzalutamide). The co-primary endpoints of the trial are progression-free survival and overall survival. Additional endpoints include objective response rate, prostate-specific antigen response rate and duration of response. The trial is sponsored by Exelixis and co-funded by Roche, Ipsen and Takeda Pharmaceutical Company Limited.
The design of CONTACT-02 was informed by results from the ongoing COSMIC-021 trial — a phase 1b study of cabozantinib and atezolizumab in multiple advanced solid tumors including NSCLC, CRPC and RCC. Initial results from cohort 6 were presented at the 2020 American Society of Clinical Oncology’s Genitourinary Cancers Symposium. The interim analysis was updated with additional biomarker results and presented at the 2020 American Society of Clinical Oncology Virtual Scientific Program.
More information about CONTACT-02 is available at ClinicalTrials.gov (NCT04446117).
About CRPC According to the American Cancer Society, in 2020, approximately 192,000 new cases of prostate cancer will be diagnosed and 33,000 people will die from the disease.1 Prostate cancer that has spread beyond the prostate and does not respond to androgen-suppression therapies — a common treatment for prostate cancer — is known as metastatic CRPC.2 Researchers estimate that in 2020, 43,000 men will be diagnosed with metastatic CRPC, which has a median survival of less than two years.3,4,5
About CABOMETYX® (cabozantinib) In the U.S., CABOMETYX tablets are approved for the treatment of patients with advanced RCC and for the treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib. CABOMETYX tablets have also received regulatory approvals in the European Union and additional countries and regions worldwide.
CABOMETYX in combination with atezolizumab is not indicated for previously treated metastatic CRPC.
About Exelixis’ Collaboration with Ipsen On February 29, 2016, Exelixis and Ipsen jointly announced a collaboration agreement for the commercialization and further development of cabozantinib indications outside of the United States, Canada and Japan. On December 21, 2016, this agreement was amended to include commercialization rights for Ipsen in Canada. Ipsen has opted in to participate in the funding of CONTACT-01 and CONTACT-02. Under the parties’ collaboration agreement, Ipsen will have access to the respective study results to support potential future regulatory submissions in their territory.
About Exelixis’ Collaboration with Takeda On January 30, 2017, Exelixis and Takeda jointly announced an exclusive licensing agreement for the commercialization and further development of cabozantinib indications in Japan. Takeda has opted in to participate in the funding of CONTACT-01 and CONTACT-02. Under the parties’ collaboration agreement, Takeda will have access to the respective study results to support potential future regulatory submissions in their territory.
Exelixis holds the exclusive rights to develop and commercialize cabozantinib in the United States.
Important Safety Information
Warnings and Precautions Hemorrhage: Severe and fatal hemorrhages occurred with CABOMETYX. The incidence of Grade 3 to 5 hemorrhagic events was 5% in CABOMETYX patients in RCC and HCC studies. Discontinue CABOMETYX for Grade 3 or 4 hemorrhage. Do not administer CABOMETYX to patients who have a recent history of hemorrhage, including hemoptysis, hematemesis, or melena.
Perforations and Fistulas: Gastrointestinal (GI) perforations, including fatal cases, occurred in 1% of CABOMETYX patients. Fistulas, including fatal cases, occurred in 1% of CABOMETYX patients. Monitor patients for signs and symptoms of perforations and fistulas, including abscess and sepsis. Discontinue CABOMETYX in patients who experience a Grade 4 fistula or a GI perforation.
Thrombotic Events: CABOMETYX increased the risk of thrombotic events. Venous thromboembolism occurred in 7% (including 4% pulmonary embolism) and arterial thromboembolism in 2% of CABOMETYX patients. Fatal thrombotic events occurred in CABOMETYX patients. Discontinue CABOMETYX in patients who develop an acute myocardial infarction or serious arterial or venous thromboembolic event requiring medical intervention.
Hypertension and Hypertensive Crisis: CABOMETYX can cause hypertension, including hypertensive crisis. Hypertension occurred in 36% (17% Grade 3 and