PARIS–(COMMERCIAL THREAD)–Regulatory news:
Ipsen (Euronext: IPN; ADR: IPSEY) announced today that study CONTACT-01 failed to meet its primary endpoint of overall survival (OS) in the final analysis. The CONTACT-01 study is a Phase III clinical study evaluating Cabometyx® (cabozantinib) in combination with atezolizumab (Tecentriq®) versus docetaxel in patients with metastatic non-mutated non-small cell lung cancer (NSCLC) who have experienced disease progression on or after treatment with an immune checkpoint inhibitor and chemotherapy based on of platinum.
Howard Mayer, MD, Executive Vice President and Director of Research and Development at Ipsen, said: “ The results of the CONTACT-01 clinical trial showed the challenge of treating patients with NSCLC after the failure of previous lines of treatment. While study results fell short of the primary endpoint in this indication, we remain confident in the clinical efficacy of cabozantinib alone and in combination with another treatment in existing indications for difficult tumors. We would also like to thank the patients, their families and healthcare teams for their participation in this clinical trial. »
The safety profile of the combined treatment of cabozantinib and atezolizumab observed in the study was comparable to that usually observed with monotherapy for each treatment. No new safety signals have been identified. Detailed results from the CONTACT-01 study will be presented for presentation at a future medical conference.
CONTACT-01 is a global, multicenter, randomized, open-label, Phase III study involving 366 patients who were randomized 1:1 to the investigational cabozantinib plus atezolizumab group and the docetaxel control group. The study included patients with squamous and non-squamous NSCLC who progressed on or after anti-PD-1/PD-L1 treatment given concurrently or sequentially with chemotherapy. The primary endpoint of the study was overall survival. Secondary endpoints were progression-free survival, objective response rate, and duration of response. Results from cohort 7 in the phase 1b COSMIC-021 study inspired the design of the CONTACT-01 study. CONTACT-01 was sponsored by Roche and co-funded by Exelixis. Ipsen and Takeda Pharmaceutical Company Limited (Takeda) have elected to participate in the study and are helping to fund this study under the terms of these companies’ respective collaboration agreements with Exelixis. For more information on this test, you can consult the site ClinicalTrials.gov.
About CABOMETYX® (cabozantinib)
Cabometyx is a targeted tyrosine kinase inhibitor (TKI) that targets, among others, vascular endothelial growth factor receptor (VEGFR), c-MET, and the TAM family of receptors, which block cancer growth.
Exelixis has granted Ipsen exclusive commercialization and clinical development rights for Cabometyx outside the United States and Japan. Exelixis has granted Takeda exclusive commercialization and clinical development rights to Cabometyx for all future indications in Japan. Exelixis retains its exclusive rights to develop and commercialize Cabometyx in the United States.
In more than 60 countries outside the United States and Japan, including the European Union (EU), Cabometyx is currently indicated:
as monotherapy for the treatment of advanced renal cell carcinoma:
as first-line treatment in intermediate- or low-risk adult patients;
in adults after previous vascular endothelial growth factor (VEGF)-targeted treatment;
in combination with nivolumab for first-line treatment of advanced renal cell carcinoma in adults;
as monotherapy for the treatment of adult patients with locally advanced or metastatic differentiated thyroid cancer (DTC), refractory or radioiodine ineligible (RAI) who has progressed on or after prior systemic treatment;
as monotherapy for the treatment of hepatocellular carcinoma (HCC) in adult patients previously treated with sorafenib.
Ipsen is a mid-sized global biopharmaceutical company focused on developing innovative medicines in Oncology, Rare Diseases and Neurosciences. With revenues of €2.6 billion in specialist medicine for the 2021 financial year, Ipsen sells medicines in more than 100 countries. In addition to its external innovation strategy, Ipsen’s R&D efforts focus on its differentiated and innovative technology platforms located at the heart of global biotechnology or life sciences research clusters: Paris-Saclay, France; Oxford, United Kingdom; Cambridge, United States; Shanghai, China. Ipsen employs approximately 5,000 people worldwide. Ipsen is listed in Paris (Euronext: IPN) and in the United States through aAmerican deposit receipt (ADR: IPSEY) Level I Sponsored. Ipsen’s website is www.ipsen.com.
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