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 poor prognosis and currently no alternative treatment options.
* The ECOG score is a performance scale used to quantify the general health condition of a patient.
It is subdivided into 5 grades from 0 to 5, ranging from fully active (0) to fully disabled, then to death (5).
**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.
ABOUT OSE Immunotherapeutics
OSE Immunotherapeutics is a clinical-stage biotechnology company focused on developing and partnering therapies to control the immune system for immuno-oncology and autoimmune diseases. The company has several scientific and technological platforms including neoepitopes and agonist or antagonist monoclonal antibodies, all ideally positioned to fight cancer and autoimmune diseases. Its first-in-class clinical and preclinical portfolio has a diversified risk profile:
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OSE Immunotherapeutics Sylvie Détry Sylvie.detry@ose-immuno.com +33 153 198 757 | U.S. Media: LifeSci Communications Darren Opland, Ph.D. darren@lifescicomms.com +1 646 627 8387 |
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Forward-looking statements
This press release contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics’ management in light of its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate.
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