• The trial did not meet its primary endpoint of overall survival (OS)
• The safety profile of the combination of cabozantinib and atezolizumab was consistent with the known safety profiles for each single agent
• The clinical trial results will be presented at a future medical meeting

Regulatory News:

Ipsen (Euronext: IPN; ADR: IPSEY) announced today that the CONTACT-01 study did not meet its primary endpoint of overall survival (OS) at the final analysis. CONTACT-01 is a phase III clinical trial evaluating Cabometyx® (cabozantinib) in combination with atezolizumab (Tecentriq®) versus docetaxel in patients with unmutated metastatic non-small cell lung cancer (NSCLC) who experienced disease progression on or after treatment with an immune checkpoint inhibitor and platinum-containing chemotherapy.

Howard Mayer, M.D., Executive Vice President, Head of Research and Development at Ipsen, said: “The results from the CONTACT-01 clinical trial have shown the challenge of treating NSCLC patients after prior lines of treatment have failed. While the findings of the study have not met the primary endpoint in this setting, we remain confident in the clinical efficacy of cabozantinib alone and in combination with another treatment in existing indications in difficult-to-treat tumor types. We wish to thank the patients, their families and healthcare teams for their participation in this clinical trial.”

The safety profile of the combination of cabozantinib and atezolizumab observed in the trial was consistent with the known safety profiles for each single agent, and no new safety signals were identified. Detailed findings from CONTACT-01 will be submitted for presentation at a future medical meeting.

ENDS

About CONTACT-01

CONTACT-01 is a global, multicenter, randomized, phase 3, open-label study that enrolled 366 patients who were randomized 1:1 to the experimental arm of cabozantinib in combination with atezolizumab and the control arm of docetaxel. The study enrolled patients with both squamous and non-squamous NSCLC who progressed during or following anti-PD-1/PD-L1 therapy administered either concurrently or sequentially with chemotherapy. The primary endpoint of the trial was overall survival. Secondary endpoints included progression-free survival, objective response rate and duration of response. Results from cohort 7 of the phase 1b COSMIC-021 trial informed the CONTACT-01 trial design. CONTACT-01 was sponsored by Roche and co-funded by Exelixis. Both Ipsen and Takeda Pharmaceutical Company Limited (Takeda) opted in to participate in the trial and are contributing to the funding for this study under the terms of the companies’ respective collaboration agreements with Exelixis. More information about the trial is available at ClinicalTrials.gov.

About CABOMETYX® (cabozantinib)

Cabometyx is a multi-targeted tyrosine kinase inhibitor (TKI) with targets including vascular endothelial growth factor receptor (VEGFR), c-MET and the TAM receptor family, which block the growth of cancer.

Exelixis granted Ipsen exclusive rights for the commercialization and further clinical development of Cabometyx outside of the U.S. and Japan. Exelixis granted exclusive rights to Takeda for the commercialization and further clinical development of Cabometyx for all future indications in Japan. Exelixis holds the exclusive rights to develop and commercialize Cabometyx in the U.S.

In over 60 countries outside of the United States and Japan, including in the European Union (E.U.), Cabometyx is currently indicated as:

• Monotherapy for advanced renal cell carcinoma:
  • as first-line treatment of adult patients with intermediate or poor risk
  • in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy
• In combination with nivolumab for the first-line treatment of advanced renal cell carcinoma in adults
• 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
• Monotherapy for the treatment of hepatocellular carcinoma (HCC) in adults who have previously been treated with sorafenib.

About Ipsen

Ipsen is a global, mid-sized biopharmaceutical company focused on transformative medicines in Oncology, Rare Disease and Neuroscience. With Specialty Care sales of €2.6bn in FY 2021, Ipsen sells medicines in over 100 countries. Alongside its external-innovation strategy, the Company’s research and development efforts are focused on its innovative and differentiated technological platforms located in the heart of leading biotechnological and life-science hubs: Paris-Saclay, France; Oxford, U.K.; Cambridge, U.S.; Shanghai, China. Ipsen has around 5,000 colleagues worldwide and is listed in Paris (Euronext: IPN) and in the U.S. through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information, visit ipsen.com

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