OSE Immunotherapeutics Presents Positive Step-1 Phase 3 Results for Tedopi® in NSCLC at the European Society for Medical Oncology Virtual Congress 2020
NANTES, France, Sept. 21, 2020 (GLOBE NEWSWIRE) -- OSE Immunotherapeutics (ISIN: FR0012127173; Mnemo: OSE) presented positive results from Step-1 of its Phase 3 trial of neoepitope-based cancer vaccine Tedopi®, in patients with advanced non-small cell lung cancer (NSCLC) after failure of previous checkpoint inhibitor treatments, at the 2020 European Society for Medical Oncology (ESMO) Virtual Conference.
Alexis Peyroles, Chief Executive Officer of OSE Immunotherapeutics, said: “These are very exciting results for Tedopi® and the improvement in overall survival, which was substantially above the standard of care, demonstrates that our neoepitope cancer vaccine has the potential to make a truly important difference to the lives of advanced NSCLC patients. In addition, the significantly longer survival after progression, the sustained good ECOG performance status* and the strong safety profile for Tedopi® are further reinforcements of its therapeutic value. These results were achieved in a hard to treat cancer patient population after failure of checkpoint inhibitor treatments, further highlighting the robust potential for Tedopi®. We warmly thank all patients, their families, the investigators and the teams who participated in this study.”
Overall, benefit/risk ratio is favorable for Tedopi® and better than that of SoC in this post checkpoint inhibitors treated population.
Dr. Giuseppe Giaccone, M.D., Chief of thoracic oncology at Weill Cornell Medical College (New York), an internationally recognized expert in the field of lung cancer and developmental therapeutics and Atalante US Principal Investigator, presented these data in a mini-oral presentation at ESMO 2020 (presentation #1260MO). The Step-1 of Atalante data included the first 103 patients enrolled in the Phase 3 trial that completed a 12-month follow up by the data cut-off of February 26, 2020, before COVID-19 impact.
The study was conducted in HLA-A2 positive advanced NSCLC patients entering second- or third-line treatment after progression on immune checkpoint inhibitors (ICI), a patient population with very oor prognosis and currently no alternative treatment options.
* The ECOG score is a performance scale used to quantify the general health condition of a patient.
**mITT (multiple Intention-To-Treat) population: all randomized evaluable (=12 months survival data) patients who received at least one dose of study treatment.
***Per protocol population: ITT population without protocol major deviations defined after a blind review by NSCLC experts.
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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 Universal Registration Document filed with the AMF on 15 April 2020, including the annual financial report for the fiscal year 2019, 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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