Business Wire

IPSEN

Share
Ipsen Provides Update On Phase III CONTACT-01 Trial Evaluating Cabozantinib in Combination With Atezolizumab in Patients With Metastatic Non-small Cell Lung Cancer Previously Treated With Immunotherapy and Chemotherapy

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

Ipsen’s Forward-Looking Statements
The forward-looking statements, objectives and targets contained herein are based on Ipsen’s management strategy, current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein. All of the above risks could affect Ipsen’s future ability to achieve its financial targets, which were set assuming reasonable macroeconomic conditions based on the information available today. Use of the words ‘believes’, ‘anticipates’ and ‘expects’ and similar expressions are intended to identify forward-looking statements, including Ipsen’s expectations regarding future events, including regulatory filings and determinations. Moreover, the targets described in this document were prepared without taking into account external growth assumptions and potential future acquisitions, which may alter these parameters. These objectives are based on data and assumptions regarded as reasonable by Ipsen. These targets depend on conditions or facts likely to happen in the future, and not exclusively on historical data. Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties, notably the fact that a promising medicine in early development phase or clinical trial may end up never being launched on the market or reaching its commercial targets, notably for regulatory or competition reasons. Ipsen must face or might face competition from generic medicine that might translate into a loss of market share. Furthermore, the research and development process involves several stages each of which involves the substantial risk that Ipsen may fail to achieve its objectives and be forced to abandon its efforts with regards to a medicine in which it has invested significant sums. Therefore, Ipsen cannot be certain that favorable results obtained during preclinical trials will be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the medicine concerned. There can be no guarantees a medicine will receive the necessary regulatory approvals or that the medicine will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Other risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and healthcare legislation; global trends toward healthcare cost containment; technological advances, new medicine and patents attained by competitors; challenges inherent in new-medicine development, including obtaining regulatory approval; Ipsen's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Ipsen’s patents and other protections for innovative medicines; and the exposure to litigation, including patent litigation, and/or regulatory actions. Ipsen also depends on third parties to develop and market some of its medicines which could potentially generate substantial royalties; these partners could behave in such ways which could cause damage to Ipsen’s activities and financial results. Ipsen cannot be certain that its partners will fulfil their obligations. It might be unable to obtain any benefit from those agreements. A default by any of Ipsen’s partners could generate lower revenues than expected. Such situations could have a negative impact on Ipsen’s business, financial position or performance. Ipsen expressly disclaims any obligation or undertaking to update or revise any forward-looking statements, targets or estimates contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based, unless so required by applicable law. Ipsen’s business is subject to the risk factors outlined in its registration documents filed with the French Autorité des Marchés Financiers. The risks and uncertainties set out are not exhaustive and the reader is advised to refer to Ipsen’s 2021 Universal Registration Document, available on ipsen.com

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

View source version on businesswire.com: https://www.businesswire.com/news/home/20221208005640/en/

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com
DK

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

SE Labs Award Reinforces NetApp Status as the Most Secure Storage on the Planet2.7.2025 14:00:00 CEST | Press release

NetApp wins 2025 SE Labs Award for Enterprise Data Protection NetApp® (NASDAQ: NTAP), the intelligent data infrastructure company, today announced that it was recognized as a standout performer in cybersecurity in the SE LABS ® Awards 2025. NetApp won the 2025 SE Labs Award for Enterprise Data Protection, validating NetApp’s status as the most secure storage on the planet. This recognition as a winner of a 2025 SE Labs Award is a result of NetApp’s exceptional innovation in cyber resiliency to deliver NetApp ONTAP® Autonomous Ransomware Protection with Artificial Intelligence (ARP/AI), which was tested and validated by SE Labs. NetApp ARP/AI demonstrated 99 percent detection of tested, advanced full-file encryption ransomware attacks with zero false positives, indicating a strong ability to operate in a business context without contributing to alert fatigue. “Great security doesn’t just happen—it’s built, tested and proven,” says Simon Edwards, Founder and CEO of SE Labs. “Behind every

CroíValve Announces Funding from Horizon Europe EIC Accelerator2.7.2025 14:00:00 CEST | Press release

CroíValve, a pioneering medical device company innovating a better way to help more patients suffering from Tricuspid Regurgitation (TR), was awarded funding from Horizon Europe’s European Innovation Council (EIC) Accelerator Programme. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250702306192/en/ DUO™ Transcatheter Tricuspid System Part of the EU’s Horizon Europe 2021-2027 Research and Innovation Programme, the EIC Accelerator Programme provides transformational funding to high-potential, high-risk start-ups, scale-ups and subject matter experts. This award includes grant funding of €2.5 million, combined with an equity investment of €10 million in CroiValve’s next financing. The latest competition included 959 applications, with only 40 awards across 16 countries. Almost one third of the selected companies are led by a woman and CroiValve are incredibly proud to be one of this group. “Securing European Innovation Council

EUMETSAT: Europe’s First Geostationary Sounder Satellite Is Launched2.7.2025 13:20:00 CEST | Press release

Europe has taken a major step forward in strengthening its resilience to extreme weather events with the successful launch of the Meteosat Third Generation Sounder 1 (MTG-S1) satellite. MTG-S1 will deliver new streams of atmospheric data, enabling earlier, more accurate warnings that protect lives, property and infrastructure. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250702002782/en/ MTG-S1 is part of the Meteosat Third Generation programme, Europe’s new fleet of geostationary meteorological satellites. Image: EUMETSAT Extreme weather events like storms, flooding, and heatwaves have caused hundreds of billions of euros in damage and claimed tens of thousands of lives across Europe in the past decades. Launched on 1 July 2025, MTG-S1 will provide Europe’s national meteorological services with high-frequency data on temperature, humidity and trace gases throughout the atmosphere – enabling forecasters to detect the earli

HCLTech and Equinor Expand Digital Collaboration2.7.2025 13:08:00 CEST | Press release

HCLTech, a global technology leader, and Equinor, Europe's largest energy supplier and a pioneer in renewables and low-carbon solutions, have expanded their IT collaboration to support the next phase of Equinor’s digital transformation. This expanded relationship will cover Equinor’s IT landscape across several key strategic areas. HCLTech will support Equinor as it accelerates its digital transformation by: Accelerating its cloud migration and standardizing services across operations Enhancing its cyber resilience and network performance Improving workplace experience through automation Enabling advanced user experiences with technologies like augmented reality (AR) "We’re pleased to continue our long-standing collaboration with Equinor," said Sandeep Kumar Saxena, Executive Vice President, HCLTech. "This collaboration reflects our shared commitment to innovation and sustainability.” Over the past decade, HCLTech has been a trusted advisor to Equinor, supporting the company’s global e

Wizz Air Tops Major Airline Emissions Rankings2.7.2025 11:00:00 CEST | Press release

Cirium, the aviation analytics company, creates a new transparent standard and ranking for airline CO2 emissions, identifying the best performing airlines in specific categories Wizz Air is the world's most emissions-efficient airline in new rankings released today by Cirium, the aviation analytics firm. The Cirium Flight Emissions Review ranks the top 20 airlines globally, through a consistent benchmark for flight emissions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250702342529/en/ The top 20 Major airlines globally, ranked by lowest CO2/ASK Wizz Air, the Hungary-based ultra-low-cost airline emits an industry low of 53.9 grams of CO₂ per Available Seat Kilometer (ASK)*, followed by Frontier Airlines (54.4 grams) and Pegasus (57.1 grams) according to the report. The rankings provide the aviation industry with verified comparable data on an equal playing field as the sector advances toward Net Zero by 2050 commitments.

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye