– Initiation follows positive results from cohort 7 of phase 1b COSMIC-021 trial –
– CONTACT-01 is the first of three phase 3 pivotal trials that are part of a previously announced clinical collaboration with Roche –
ALAMEDA, Calif.--(BUSINESS WIRE)-- Exelixis, Inc. (NASDAQ: EXEL) today announced the initiation of CONTACT-01, a global phase 3 pivotal trial of cabozantinib (CABOMETYX®) in combination with atezolizumab (TECENTRIQ®) in patients with metastatic non-small cell lung cancer (NSCLC) who have been previously treated with an immune checkpoint inhibitor (ICI) and platinum-containing chemotherapy. Two additional phase 3 pivotal trials in metastatic castration-resistant prostate cancer (CRPC; CONTACT-02) and renal cell carcinoma (RCC; CONTACT-03) are planned as part of the clinical trial collaboration between Exelixis and Roche.
“Survival rates for patients with metastatic non-small cell lung cancer are low, and since more than half of these patients are diagnosed at an advanced stage, the patient community is in need of new treatment options, especially for those who progress following immunotherapy and chemotherapy,” said Gisela Schwab, M.D., President, Product Development and Medical Affairs and Chief Medical Officer, Exelixis. “We were pleased to see the positive results from cohort 7 of the COSMIC-021 trial further supporting the growing body of preclinical and clinical evidence that cabozantinib may promote a more immune-permissive environment potentially resulting in additive or synergistic effects with immune checkpoint inhibitors such as atezolizumab. We look forward to forthcoming findings for the combination in this disease in CONTACT-01, as well as in other difficult-to-treat cancers in planned phase 3 studies.”
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 — informed the design of this phase 3 pivotal trial. Initial results from the COSMIC-021 cohort of patients with advanced NSCLC who progressed after treatment with an ICI were presented at the 2020 American Society of Clinical Oncology Virtual Scientific Program.
CONTACT-01 is a global, multicenter, randomized, phase 3, open-label study that aims to enroll approximately 350 patients. Patients will be randomized 1:1 to the experimental arm of cabozantinib in combination with atezolizumab and the control arm of docetaxel. The primary endpoint of the trial is overall survival. Secondary endpoints include progression-free survival, objective response rate and duration of response. The trial is sponsored by Roche and co-funded by Exelixis.
About NSCLC
Lung cancer is the second most common type of cancer in the U.S., with more than 220,000 new cases expected to be diagnosed in 2020.1 The disease is the leading cause of cancer-related mortality in both men and women, causing 25% of all cancer-related deaths.1 The majority (84%) of lung cancer cases are NSCLC, which mainly comprise adenocarcinoma, squamous cell carcinoma and large cell carcinoma.1 The five-year survival rate for patients with NSCLC is 24%, but that rate falls to just 6% for those with advanced or metastatic disease.2 More than half of lung cancer cases are diagnosed at an advanced stage, and more options are needed for these patients.3
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 HCC 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 non-small cell lung cancer.
About Exelixis’ Collaboration with Ipsen
On February 29, 2016, Exelixis and Ipsen jointly announced an exclusive licensing 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. Under the parties’ collaboration agreement, if Ipsen opts to participate in funding this phase 3 trial, or future studies, 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. Under the parties’ collaboration agreement, if Takeda opts to participate in funding this phase 3 trial, or future studies, 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