– Based on continued encouraging efficacy and safety data, metastatic castration-resistant prostate cancer cohort further expanded to 130 patients –
– Initial data to be presented on February 13 at the 2020 American Society of Clinical Oncology’s Genitourinary Cancers Symposium (ASCO GU 2020) in San Francisco, CA –
ALAMEDA, Calif.--(BUSINESS WIRE)-- Exelixis, Inc. (NASDAQ: EXEL) today announced that based on continued encouraging efficacy and safety data, the company plans to further expand the metastatic castration-resistant prostate cancer (CRPC) cohort of COSMIC-021, the phase 1b trial of cabozantinib (CABOMETYX®) in combination with atezolizumab (TECENTRIQ®) in patients with locally advanced or metastatic solid tumors. The cohort, which was previously expanded from 30 to 80 patients in July 2019, will now include up to 130 patients.
“We continue to see encouraging efficacy and safety data from the prostate cancer cohort in COSMIC-021,” said Gisela Schwab, M.D., President, Product Development and Medical Affairs and Chief Medical Officer, Exelixis. “Expanding this cohort by an additional 50 patients will allow us to further document how the combination of cabozantinib and atezolizumab may benefit this patient population as we assess our potential regulatory plans for the combination and prepare to initiate a phase 3 pivotal trial. We look forward to the presentation of initial data from this cohort of CRPC patients at ASCO GU 2020 in February.”
Based on preliminary encouraging activity, as determined by response assessment per Response Evaluation Criteria in Solid Tumors (version 1.1) (RECISTv1.1), and safety data of patients enrolled in the metastatic CRPC cohort, 50 additional patients with metastatic CRPC (130 total) who have histologically or cytologically confirmed adenocarcinoma of the prostate are being enrolled in the trial.
Initial data from the CRPC cohort in COSMIC-021 will be presented at ASCO GU 2020 in San Francisco on Thursday, February 13th during Poster Session A: Prostate Cancer at 11:30 a.m. – 1:00 p.m. PT and again at 5:30 – 6:30 p.m. PT.
COSMIC-021 includes 24 cohorts and aims to enroll up to 1,732 patients with advanced or metastatic solid tumors including CRPC, renal cell carcinoma (RCC), hepatocellular carcinoma (HCC), non-small cell lung cancer (NSCLC), colorectal cancer, ovarian cancer, and urothelial carcinoma (UC), among others. The primary objective in the expansion stage of this trial is to determine the objective response rate in each cohort. More information about the currently enrolling cohorts in this trial is available at ClinicalTrials.gov. To date, early data from various cohorts of this study have informed the initiation or planned initiation of several phase 3 pivotal trials, evaluating the combination in advanced HCC, CRPC, NSCLC and RCC.
TECENTRIQ® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.
About the COSMIC-021 Study
COSMIC-021 is a multicenter, phase 1b, open-label study that is divided into two parts: a dose-escalation phase and an expansion cohort phase. The dose-escalation phase was designed to enroll patients either with advanced RCC with or without prior systemic therapy or with inoperable, locally advanced, metastatic or recurrent UC (including renal, pelvis, ureter, urinary bladder and urethra) after prior platinum-based therapy. Ultimately, all 12 patients enrolled in this stage of the trial were patients with advanced RCC. The dose-escalation phase of the study determined the optimal dose of cabozantinib to be 40 mg daily when given in combination with atezolizumab (1200 mg infusion once every 3 weeks). These results were presented at the European Society for Medical Oncology 2018 Congress.
In the expansion phase, the trial is enrolling 24 cohorts in 12 tumor types: RCC, UC, NSCLC, CRPC, HCC, triple-negative breast cancer, epithelial ovarian cancer, endometrial cancer, gastric or gastroesophageal junction adenocarcinoma, colorectal adenocarcinoma, head and neck cancer, and differentiated thyroid cancer. Up to 1,720 patients may enroll in this phase of the trial: each expansion cohort will initially enroll approximately 30 patients, and up to 10 cohorts may expand enrollment up to 1,000 additional patients in the expansion phase.
Four of the cohorts are exploratory: three are enrolling approximately 30 patients each with advanced UC, CRPC or NSCLC to be treated with cabozantinib as a single-agent, and one is enrolling approximately 10 patients with advanced CRPC to be treated with single-agent atezolizumab. Exploratory cohorts have the option to be expanded up to 80 patients (cabozantinib) and 30 patients (atezolizumab) total.
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. In 2016, Exelixis granted Ipsen exclusive rights for the commercialization and further clinical development of cabozantinib outside of the United States 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.
Please see Important Safety Information below and full U.S. prescribing information at https://cabometyx.com/downloads/CABOMETYXUSPI.pdf.
U.S. Important Safety Information
- Hemorrhage: Severe and fatal hemorrhages occurred with CABOMETYX. The incidence of Grade 3 to 5 hemorrhagic events was 5% in CABOMETYX patients. 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: GastrointestinaI (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 fistula that cannot be appropriately managed 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