On September 5, 2022 OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) reported the presentation of two new analyses from the Phase 3 Atalante-1 study of immunotherapy Tedopi, in patients with advanced non-small cell lung cancer (NSCLC) in secondary resistance after failure of previous checkpoint inhibitor treatments, at the 2022 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, being held September 9-13, in Paris (Press release, OSE Immunotherapeutics, SEP 5, 2022, View Source [SID1234646962]).

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Alexis Vandier, Chief Executive Officer of OSE Immunotherapeutics, commented: "In patients with no treatment option after failure of two therapeutic classes, in particular post-checkpoint inhibitors, Tedopi has shown an overall clinical benefit in this phase 3 study, integrating both efficacy and tolerance compared to chemotherapy treatments. This new specific immunotherapy offers prospects for therapeutic management, both in monotherapy and in combination, and we will do our best to make this treatment available as soon as possible for these patients."

The first analysis compared Tedopi to the Standard of Care (SoC) in patients with advanced NSCLC after secondary resistance to sequential use of chemotherapy followed by immunotherapy (CT-IO).

The results have shown that in advanced HLA-A2+ NSCLC patients with IO secondary resistance after sequential CT-IO (n=118), overall survival (OS) was longer with Tedopi versus SoC regardless of the use (or not) of post progression anticancer treatment (with 13.5 months versus 10.6, HR=0.71; without 6.3 months versus 4.5, HR=0.76).

This analysis will be presented by Dr Maria Rosario Garcia Campelo (Head of Medical Oncology Department, Thoracic Tumors Unit, Investigator of Atalante-1 study, University Hospital A Coruña, Spain).

Dr Garcia Campelo said: "There is a strong medical need for a new therapeutic alternative in these heavily pretreated NSCLC patients, aiming not only at a prolonged survival but desiring a maintained global health status."

The second analysis assessed the overall benefit/risk of Tedopi versus SoC chemotherapy in patients with NSCLC who failed therapy with immune checkpoint inhibitors. The Net Treatment Benefit (NTB)*, a new statistical method combining efficacy, safety and quality of life, was assessed in the overall population (n=219). NTB of Tedopi was of 19% and reached statistical significance (p=0.035).

This analysis will be presented by Dr Marc Buyse, (Founder and Chief Scientific Officer, International Drug Development Institute (IDDI), Brussels, Belgium).

Poster presentation details:
Title: Pattern of clinical activity of anticancer vaccine OSE2101 in HLA-A2+ non-small cell lung cancer (NSCLC) patients after failure to immune checkpoint inhibitors (IO) in Phase 3 Atalante-1 randomized trial
Presentation Number: 1019P
Speaker: Maria Rosario Garcia Campelo (A Coruña, Spain)
Date: Monday, September 12th, 2022

Title: Net Treatment Benefit of OSE2101 in HLA-A2+ non-small cell lung cancer (NSCLC) patients after failure to immune checkpoint inhibitors (IO) in Phase 3 Atalante-1 randomized trial
Presentation Number: 1024P
Speaker: Marc E. Buyse (Louvain-la-Neuve, Ottignies, Belgium)
Date: Monday, September 12th, 2022