Exelixis’ Partner Ipsen Receives European Commission Approval for CABOMETYX® (cabozantinib) for Patients with Previously Treated Radioactive Iodine-Refractory Differentiated Thyroid Cancer

– Approval is based on COSMIC-311 trial, in which CABOMETYX demonstrated significant improvement in progression-free survival versus placebo –

ALAMEDA, CA, USA I May 03, 2022 I Exelixis, Inc. (Nasdaq: EXEL) today announced that its partner Ipsen received approval from the European Commission (EC) for CABOMETYX® (cabozantinib) as a monotherapy for the treatment of adult patients with locally advanced or metastatic differentiated thyroid carcinoma (DTC), refractory or not eligible to radioactive iodine (RAI) who have progressed during or after prior systemic therapy. This approval allows for the marketing of CABOMETYX in this indication in all 27 member states of the European Union, Norway, Liechtenstein and Iceland.

“We are excited that CABOMETYX will now be available in Europe for patients with locally advanced or metastatic differentiated thyroid carcinoma who have progressed during or after prior systemic therapy, that previously had no approved standard treatment options,” said Vicki L. Goodman, M.D., Executive Vice President, Product Development and Medical Affairs, and Chief Medical Officer, Exelixis. “The European Commission approval is an additional step in our partnership with Ipsen to provide new treatment options for more eligible patients with difficult-to-treat cancer types.”

The EC approval is based on results from COSMIC-311, the phase 3 pivotal trial that demonstrated significant improvement in progression-free survival (PFS) with CABOMETYX versus placebo in patients with RAI-refractory DTC who progressed after up to two prior VEGFR-targeted therapies. COSMIC-311 was the basis for the U.S. Food and Drug Administration (FDA) approval of CABOMETYX in September 2021 for the treatment of adult and pediatric patients 12 years of age and older with locally advanced or metastatic DTC that has progressed following VEGFR-targeted therapy and who are RAI-refractory or ineligible.

CABOMETYX is also approved in the European Union as a monotherapy for the treatment of advanced renal cell carcinoma (RCC) in adults who have received prior VEGFR-targeted therapy, for previously untreated intermediate- or poor-risk advanced RCC and for hepatocellular carcinoma (HCC) in adults who have been previously treated with sorafenib. CABOMETYX in combination with OPDIVO® (nivolumab) is approved as a first-line treatment for advanced RCC.

About COSMIC-311

COSMIC-311 was a multicenter, randomized, double-blind, placebo-controlled phase 3 pivotal trial that enrolled 258 patients at 164 sites globally. Patients were randomized in a 2:1 ratio to receive either CABOMETYX 60 mg or placebo once daily. The primary endpoints were PFS and objective response rate. Exelixis is sponsoring COSMIC-311, and Ipsen is co-funding the trial. More information about this trial is available at ClinicalTrials.gov.

About DTC

In 2020, over 580,000 new cases of thyroid cancer were diagnosed worldwide.1 Approximately 44,000 new cases of thyroid cancer will be diagnosed in the U.S. in 2022. Nearly three out of four of these cases will be in women, and the disease is more commonly diagnosed at a younger age compared with most other adult cancers. While cancerous thyroid tumors include differentiated, medullary and anaplastic forms, differentiated thyroid tumors make up about 90% of cases and includes papillary, follicular and Hürthle cell cancer.2 DTC is typically treated with surgery followed by ablation of the remaining thyroid with RAI, but approximately 5% to 15% of cases are resistant to RAI treatment.3,4 For these patients, life expectancy is only three to six years from the time metastatic lesions are detected.5,6,7

About CABOMETYX® (cabozantinib)

In the U.S., CABOMETYX tablets are approved for the treatment of patients with advanced RCC; for the treatment of patients with 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 DTC that has progressed following prior VEGFR-targeted therapy and who are RAI-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. Under the terms of the license agreement with Ipsen, Exelixis is eligible to receive development, regulatory and sales milestone payments from Ipsen and further receive royalties on net sales of cabozantinib by Ipsen outside of the U.S. 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. Exelixis holds the exclusive rights to develop and commercialize cabozantinib in the U.S.

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 Sung. H et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA: A Cancer Journal For Clinicians. doi: 10.3322/caac.21660.
2 American Cancer Society. About Thyroid Cancer. Available at: https://www.cancer.org/cancer/thyroid-cancer/about.html. Accessed May 2022.
3 UpToDate. Differentiated thyroid cancer: Overview of management. Available at: https://www.uptodate.com/contents/differentiated-thyroid-cancer-overview-of-management. Accessed May 2022.
4 Worden F. 2014. Treatment strategies for radioactive iodine-refractory differentiated thyroid cancer. Ther Adv Med Oncol. 6:267–279.
5 Xing M, Haugen BR, Schlumberger M. 2013. Progress in molecular-based management of differentiated thyroid cancer. Lancet. 381:1058–1069.
6 Pacini F, et al. 2012. Radioactive iodine-refractory differentiated thyroid cancer: unmet needs and future directions. Expert Rev Endocrinol Metab. 7:541–554.
7 Durante C, et al. 2006. Long-term outcome of 444 patients with distant metastases from papillary and follicular thyroid carcinoma: benefits and limits of radioiodine therapy. J Clin Endocrinol Metab. 91:2892–2899.

SOURCE: Exelixis

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