• Clinical collaboration marks an important milestone in partnership with Exelixis to further develop cabozantinib

• Participation will provide Ipsen access to the respective study results to support potential future regulatory submissions in its territories

PARIS, FRANCE, 02 July 2020 – Ipsen (Euronext: IPN; ADR: IPSEY), today announced it will join the Exelixis and Roche clinical collaboration and participate in the funding of the recently initiated CONTACT-01 and CONTACT-02 global Phase III pivotal trials. CONTACT-01 is evaluating the safety and efficacy 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 and platinum-containing chemotherapy. CONTACT-02 is evaluating the safety and efficacy of cabozantinib given in combination with atezolizumab versus a second novel hormonal therapy (NHT) in men with metastatic castration-resistant prostate cancer (CRPC) who have previously been treated with one NHT.
“There is a growing body of preclinical and clinical evidence that cabozantinib may positively impact treatment when paired with immunotherapy,” said Dr. Howard Mayer, Executive Vice President and Head of Research and Development at Ipsen. “We are pleased to enter into this collaboration with Exelixis and Roche to build on the promising data from COSMIC-021 and further examine the potential of cabozantinib in combination with atezolizumab to treat metastatic non-small cell lung cancer and for men with metastatic castration-resistant prostate cancer.”
“Ipsen has built its strength in oncology through solid long-term partnerships which are evaluating new approaches to target difficult-to-treat cancers. This marks an important milestone in our partnership with Exelixis to further develop cabozantinib and our shared vision to progress the treatment for cancers and indications with high unmet need, ensuring no patient is left behind,” said Bartek Bednarz, Senior Vice President, Global Product & Portfolio Strategy at Ipsen.
Ipsen has an exclusive collaboration agreement with Exelixis for the further development and commercialization of cabozantinib outside of the United States and Japan. Under this agreement, following its decision to opt-in to pivotal studies exploring cabozantinib’s potential in new potential indications, Ipsen gains access to the results of those studies, which if positive, may support potential future regulatory submissions in its territory.
Tecentriq® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.

About CONTACT-01
CONTACT-01 is a global, multicenter, randomized, Phase III, 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 was initiated on June 11, 2020 and is sponsored by Roche and co-funded by Exelixis, Ipsen and Takeda Pharmaceutical Company Limited.

About NSCLC
Lung cancer is the most commonly occurring cancer in men and the third most commonly occurring cancer in women.1 There were over two million new cases in 2018.2 Non-small-cell lung carcinoma (NSCLC) is any type of epithelial lung cancer other than small cell lung carcinoma (SCLC). NSCLC accounts for about 85% of all lung cancers.3,4

About CONTACT-02
CONTACT-02 is a global, multicenter, randomized, Phase III, 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 was initiated on June 30, 2020 and is sponsored by Exelixis and co-funded by Roche, Ipsen and Takeda Pharmaceutical Company Limited.

About CRPC
Prostate cancer is the second most commonly occurring cancer in men and the fourth most commonly occurring cancer overall.5 There were 1.27 million new cases in 2018.6 Approximately 10-20 percent of prostate cancer cases are castration-resistant, and up to 16% of these patients show no evidence that the cancer has spread at the time of the castration-resistant diagnosis.
Metastatic castration-resistant prostate cancer is when the cancer has spread to parts of the body other than the prostate, and it is able to grow and spread even though drugs or other treatments to lower the amount of male sex hormones are being used to manage the cancer.

About Ipsen products
This press release mentions investigational uses of Ipsen products. Product indications and approvals for use vary by jurisdiction; please see SmPC/PI for full indications and safety information.

About CABOMETYX® (cabozantinib)
CABOMETYX® is not marketed by Ipsen in the U.S.
CABOMETYX® 20mg, 40mg and 60mg film-coated unscored tablets
Active ingredient: Cabozantinib (S)-malate 20mg, 40mg and 60mg
Other components: Lactose
Indications: CABOMETYX® is currently approved in 51 countries, including  in the European Union, the U.K., Norway, Iceland, Australia, Switzerland, South Korea, Canada, Brazil, Taiwan, Hong-Kong, Singapore, Macau, Jordan, Lebanon, Russian Federation, Ukraine, Turkey, United Arab Emirates, Saudi Arabia, Serbia, Israel, Mexico, Chile and Panama for the treatment of advanced RCC in adults who have received prior VEGF-targeted therapy; in the European Union, the U.K., Norway, Iceland, Canada, Australia, Brazil, Taiwan, Hong Kong, Singapore, Jordan, Russian Federation, Turkey, United Arab Emirates, Saudi Arabia, Servia, Israel, Mexico, Chile and Panama for previously untreated intermediate- or poor-risk advanced RCC; and in the European Union, the U.K., Norway, Iceland, Canada, Australia, Switzerland, Saudi Arabia, Serbia, Israel , Taiwan, Hong Kong, South Korea, Singapore, Jordan, Russian Federation, Turkey, United Arab Emirates,  and Panama for HCC in adults who have previously been treated with sorafenib.
 For more information, see the regularly updated registered product information on the European Medicine Agency www.ema.europa.eu
CABOMETYX® is marketed by Exelixis, Inc. in the United States. Ipsen has exclusive rights for the commercialization and further clinical development of CABOMETYX® outside of the United States and Japan.

U.S. Indications and Important Safety Information
Indications:
CABOMETYX® (cabozantinib) is indicated for the treatment of patients with advanced renal cell carcinoma (RCC).
CABOMETYX® (cabozantinib) is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
Please see full Prescribing Information for more information.

For further information:

References

1. World Cancer Research Fund. Lung Cancer Statistics. Accessed: July 2020. Available from: https://www.wcrf.org/dietandcancer/cancer-trends/lung-cancer-statistics.
2. GLOBOCAN 2018. Lung Cancer Factsheet. Accessed: July 2020. Available from: https://gco.iarc.fr/today/data/factsheets/cancers/15-Lung-fact-sheet.pdf.
3. Medscape eMedicine. Non-Small Cell Lung Cancer. Accessed: July 2020. Available from: https://emedicine.medscape.com/article/279960-overview.
4. American Cancer Society. Non-Small Cell Lung Cancer (NSCLC). Accessed: July 2020. Available from: https://www.cancer.org/cancer/lung-cancer/about/what-is.html.
5. World Cancer Research Fund. Prostate Cancer Statistics. Accessed: July 2020. Available from here.
6. GLOBOCAN 2018. Prostate Cancer Factsheet. Accessed: July 2020. Available from: https://gco.iarc.fr/today/data/factsheets/cancers/27-Prostate-fact-sheet.pdf.

Attachment

• Ipsen-Clinical-collaboration-to-evaluate-Cabometyx-2-July-2020