Ipsen Announces Results of Phase III CONTACT-01 Study Evaluating Cabozantinib in Combination with Atezolizumab in Immunotherapy- and Chemotherapy-experienced Patients With Metastatic NSCLC

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.

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About CONTACT-01

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.

About Ipsen

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.

Ipsen disclaimer

The forward-looking statements and objectives contained in this presentation are based on the current strategy and assumptions of Ipsen’s management. Such statements and objectives are subject to known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those contemplated in this press release. Such risks and random factors could affect Ipsen’s ability to achieve its financial objectives, which are based on reasonable macroeconomic conditions, based on information currently available. The use of the words “believes,” “intends,” and “expects” or similar expressions are intended to identify forward-looking statements, including Ipsen’s expectations regarding future events, including communications and regulatory decisions. Furthermore, the forecasts quoted in this document are established without any future external growth operations that could modify these parameters. These forecasts are based in particular on data and assumptions considered reasonable by Ipsen. and depend on circumstances or facts that will probably occur in the future, some of which are beyond the control of the Group, and not exclusively on historical data. Actual results could differ materially from these targets due to the materialization of certain risks or uncertainties, and in particular that a new drug may appear promising during a preparatory phase of development or after clinical trials, but never be commercialized or fail to meet the targets. its commercial objectives, in particular for regulatory or competitive reasons. Ipsen faces or is likely to face generic drug competition which could lead to market share losses. Furthermore, the research and development process involves several stages and, in each stage, there is a significant risk that Ipsen will fail to achieve its objectives and may be led to give up pursuing its efforts on a drug in which it has invested significant. Furthermore, Ipsen cannot be confident that favorable results obtained during preclinical studies will subsequently be confirmed during clinical studies or that clinical study results will be sufficient to demonstrate the safe and effective nature of the drug in question. There can be no assurance that a drug will receive the necessary approvals or achieve its commercial goals. Actual results could differ materially from those of the forward-looking statements if underlying assumptions prove inaccurate or certain risks or uncertainties materialize. Other risks and uncertainties include, but are not limited to, general industry conditions and competition; general economic factors, including fluctuations in interest rates and exchange rates; the impact of pharmaceutical industry regulation and healthcare legislation; global trends toward health care cost containment; technological advances, new drugs and patents obtained by competitors; matters relating to the development of new drugs, including obtaining approval; Ipsen’s ability to accurately predict future market conditions; production difficulties or delays; financial instability of the international economy and sovereign risk; dependence on the efficacy of Ipsen’s patents and other innovative drug protections; and the risk of litigation, including patent litigation and/or regulatory action. Ipsen also depends on third parties for the development and marketing of its medicines, which could potentially generate substantial royalties; these partners may act in a way that could negatively impact Ipsen’s business as well as its financial results. Ipsen can’t be sure its partners will honor their commitments. Therefore, the Group may not be able to benefit from such arrangements. A default by one of Ipsen’s partners could lead to an unexpected drop in revenue. Such situations could have an adverse impact on Ipsen’s business, financial condition or results. Subject to applicable law, Ipsen makes no commitment to update or revise any forward-looking statements or goals referenced in this press release to reflect changes that may occur in the events, situations, assumptions or circumstances upon which they are based. such statements. Ipsen’s business is subject to risk factors described in its disclosure documents registered with the Autorité des marchés financiers. The risks and uncertainties presented are not the only ones faced by the Group and the reader is invited to read Ipsen’s Universal Registration Document 2021, which is available on its website. www.ipsen.com.

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