Exelixis Announces Initiation of the STELLAR-303 Phase 3 Pivotal Trial Evaluating XL092 in Patients with Metastatic Colorectal Cancer

– STELLAR-303 is the first phase 3 pivotal trial evaluating XL092, a next-generation oral tyrosine kinase inhibitor –

ALAMEDA, CA, USA I June 21, 2022 I Exelixis, Inc. (Nasdaq: EXEL) today announced the initiation of STELLAR-303, a phase 3 pivotal trial evaluating XL092 in combination with atezolizumab versus regorafenib in patients with metastatic colorectal cancer (CRC) that is not microsatellite instability-high or mismatch repair-deficient, who have progressed after or are intolerant to the standard of care therapy. XL092 is a next-generation tyrosine kinase inhibitor (TKI) in development for multiple advanced tumor types.

“There is a significant need for new treatment options for the majority of metastatic CRC patients, who do not have microsatellite instability-high or mismatch-repair deficient disease and whose tumors do not respond to immunotherapy alone,” said Vicki L. Goodman, M.D., Executive Vice President, Product Development & Medical Affairs, and Chief Medical Officer, Exelixis. “Following recent promising data evaluating cabozantinib in combination with immunotherapies in colorectal cancer, we are thrilled to initiate our first phase 3 pivotal trial for XL092, our next-generation tyrosine kinase inhibitor. We look forward to learning more about how XL092 in combination with atezolizumab may benefit patients with metastatic colorectal cancer.”

STELLAR-303 is a global, multicenter, randomized phase 3 open-label study that will enroll approximately 600 patients with documented RAS status. Patients will be randomized 1:1 to receive either XL092 in combination with atezolizumab or regorafenib. The primary objective of the study is to evaluate the efficacy of the combination in patients with RAS wild-type disease; exploratory endpoints include examining efficacy in those with RAS-mutated disease. The primary endpoint is overall survival. Secondary endpoints include progression-free survival, objective response rate and duration of response per Response Evaluation Criteria in Solid Tumors version 1.1 as assessed by the investigator.

Previously announced results from two studies of cabozantinib in combination with immunotherapies for the treatment of advanced CRC supported Exelixis’ decision to pursue clinical development of XL092 in this setting. The trial is sponsored by Exelixis, and Roche is supplying atezolizumab.

About XL092

XL092 is a next-generation oral TKI that inhibits the activity of receptor tyrosine kinases implicated in cancer growth and spread, including VEGF receptors, MET, AXL and MER. These receptor tyrosine kinases are involved in both normal cellular function and in pathologic processes such as oncogenesis, metastasis, tumor angiogenesis and resistance to multiple therapies, including immune checkpoint inhibitors. In designing XL092, Exelixis sought to build upon its extensive experience with and the target profile of cabozantinib, the company’s flagship medicine, while improving key characteristics, including pharmacokinetic half-life. XL092 is currently being developed for the treatment of advanced solid tumors, including genitourinary cancers, as a monotherapy and in combination with immune checkpoint inhibitors. XL092 is the first internally discovered Exelixis compound to enter the clinic following the company’s reinitiation of drug-discovery activities.

About Colorectal Cancer

Colorectal cancer is the third most common cancer and the third-leading cause of cancer-related deaths in the U.S. According to the American Cancer Society, about 150,000 new cases will be diagnosed and 53,000 people will die from the disease in 2022.1 Colorectal cancer is most frequently diagnosed among people aged 65-74 and is more common in men and those of African American descent. Nearly a quarter of colorectal cancer cases are diagnosed at the metastatic stage, at which point the five-year survival rate is just 15%.2 It has been estimated that approximately 40% of metastatic colorectal cancer cases exhibit a RAS mutation.3

About CABOMETYX® (cabozantinib)

In the U.S., CABOMETYX tablets are approved for the treatment of patients with advanced renal cell carcinoma (RCC); for the treatment of patients with hepatocellular carcinoma (HCC) 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 (DTC) 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 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 is not indicated as a treatment for metastatic colorectal cancer CRC that is not microsatellite instability-high or mismatch repair-deficient.

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

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

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 Cancer Facts and Figures 2022. American Cancer Society website. Available at: https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2022/2022-cancer-facts-and-figures.pdf. Accessed June 2022.
2 Cancer Stat Facts: Colorectal Cancer. SEER website. Available at: https://seer.cancer.gov/statfacts/html/colorect.html. Accessed June 2022.
3 RAS in Colorectal Cancer: ESMO Biomarker Factsheet. OncologyPRO website. Available at https://oncologypro.esmo.org/education-library/factsheets-on-biomarkers/ras-in-colorectal-cancer. Accessed June 2022.

SOURCE: Exelixis

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