Exelixis Announces Initiation of CONTACT-02 Phase 3 Pivotal Trial of Cabozantinib in Combination With Atezolizumab in Previously Treated Metastatic Castration-Resistant Prostate Cancer

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, CA, USA I June 30, 2020 IExelixis, 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.

Please see accompanying full Prescribing Information https://cabometyx.com/downloads/CABOMETYXUSPI.pdf.

About Exelixis
Founded in 1994, Exelixis, Inc. (NASDAQ: EXEL) is a commercially successful, oncology-focused biotechnology company that strives to accelerate the discovery, development and commercialization of new medicines for difficult-to-treat cancers. Following early work in model system genetics, we established a broad drug discovery and development platform that has served as the foundation for our continued efforts to bring new cancer therapies to patients in need. Our discovery efforts have resulted in four commercially available products, CABOMETYX® (cabozantinib), COMETRIQ® (cabozantinib), COTELLIC® (cobimetinib) and MINNEBRO® (esaxerenone), and we have entered into partnerships with leading pharmaceutical companies to bring these important medicines to patients worldwide. Supported by revenues from our marketed products and collaborations, we are committed to prudently reinvesting in our business to maximize the potential of our pipeline. We are supplementing our existing therapeutic assets with targeted business development activities and internal drug discovery — all to deliver the next generation of Exelixis medicines and help patients recover stronger and live longer. Exelixis is a member of the Standard & Poor’s (S&P) MidCap 400 index, which measures the performance of profitable mid-sized companies. For more information about Exelixis, please visit www.exelixis.com, follow @ExelixisInc on Twitter or like Exelixis, Inc. on Facebook.

1 American Cancer Society: Cancer Facts & Figures 2020. Available at: https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2020/cancer-facts-and-figures-2020.pdf. Accessed June 2020.
2 American Society of Clinical Oncology. Cancer.Net. Treatment of Metastatic Castration-Resistant Prostate Cancer. September 8, 2014. Available at: https://www.cancer.net/research-and-advocacy/asco-care-and-treatment-recommendations-patients/treatment-metastatic-castration-resistant-prostate-cancer. Accessed June 2020.
3 Scher, H.I., Solo, K., Valant, J., Todd, M.B., Mehra, M. Prevalence of Prostate Cancer Clinical States and Mortality in the United States: Estimates Using a Dynamic Progression Model. PLOS ONE. 2015; 10: e0139440.
4 American Urological Association. Prostate Cancer: Castration Resistant Guideline. 2018. Available at: https://www.auanet.org/guidelines/prostate-cancer-castration-resistant-guideline. Accessed June 2020.
5 Moreira, D. M., Howard, L. E., Sourbeer, K. N., et al. Predicting Time From Metastasis to Overall Survival in Castration-Resistant Prostate Cancer: Results From SEARCH. Clin Genitourin Cancer. 2017; 15: 60–66.e2.

SOURCE: Exelixis

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