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Continuation of “Atalante 1” Phase 3 Clinical Trial of Tedopi® in NSCLC Patients Post Checkpoint Inhibitor Failure Following IDMC Recommendation | ||||||||
By: Nasdaq / GlobeNewswire - 20 Jun 2019 | Back to overview list |
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NANTES, France, June 20, 2019 (GLOBE NEWSWIRE) -- OSE Immunotherapeutics (ISIN: FR0012127173; Mnémo: OSE) today announced that, after reviewing global study data, the Independent Data Monitoring Committee (IDMC) saw no safety concerns and recommended the continuation of patient recruitment, without any modifications, of its ongoing international pivotal Phase 3 trial, called Atalante 1, evaluating Tedopi® in HLA-A2 positive non-small cell lung cancer (NSCLC) patients post immune checkpoint inhibitor failure (PD-1/PD-L1). “This new IDMC review continues to support the development of Tedopi® in NSCLC in patients with unmet medical needs. While checkpoint inhibitors are now considered the standard of care in first- and second-line treatment of advanced NSCLC, many patients still fail to respond or continue to progress on these therapies. Our Phase 3 study with Tedopi® is conducted in a patient population with no currently approved therapeutic option, and the clinical need for patients in immune escape after such treatment is strong,” said Alexis Peyroles, CEO of OSE Immunotherapeutics. ABOUT Atalante 1 ABOUT Tedopi® ABOUT OSE Immunotherapeutics Click and follow us on Twitter and Linkedln Contacts
Forward-looking statements These forward-looking statements include statements typically using conditional and containing verbs such as “expect”, “anticipate”, “believe”, “target”, “plan”, or “estimate”, their declensions and conjugations and words of similar import. Although the OSE Immunotherapeutics management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics’ shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are not guarantees of future performance. This press release includes only summary information and should be read with the OSE Immunotherapeutics Reference Document filed with the AMF on 26 April 2019, including the annual financial report for the fiscal year 2018, available on the OSE Immunotherapeutics’ website. Other than as required by applicable law, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forward-looking information or statements. |
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Copyright 2019 Nasdaq / GlobeNewswire | Back to overview list |