• Topline results to be presented by Federico Cappuzzo, MD, PhD, on October 25, 2026, at the Annual Meeting of the European Society for Medical Oncology (ESMO) in Madrid
• OSE Immunotherapeutics to host a KOL webcast on November 4, 2026

CEST – OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE), a clinical-stage biotech company dedicated to developing first-in-class therapies in immuno-oncology and immuno-inflammation, announced the release of the abstract selected for an oral presentation at the upcoming ESMO 2026 Annual Meeting, unveiling topline results from the Combi-TED academic Phase 2 international clinical trial of Tedopi® sponsored by FoRT and evaluating Tedopi® (OSE2101), in combination with either chemotherapy or anti-PD1, as a 2^nd line treatment in patients with metastatic Non-Small Cell Lung Cancer (NSCLC).

Federico Cappuzzo, MD, PhD, Director of Medical Oncology at the National Cancer Institute Regina Elena (Rome, Italy) and Lead Investigator of the trial, commented: “The only option we currently have in our practice, for these patients in second line, unfortunately remains docetaxel, which has the toxicity of chemotherapy and a limited efficacy. Tedopi® in monotherapy has already shown signs of superiority compared to docetaxel in terms of efficacy associated with a better safety and tolerability profile; the phase 3 study ARTEMIA, currently underway, was designed specifically to confirm this. In Combi-TED, we almost doubled the survival at one year with Tedopi® combined with either chemotherapy docetaxel or immunotherapy nivolumab, an extremely encouraging result that represents a new step forward in the treatment strategy for patients with progressive NSCLC.”

Combi-TED is an open label, randomized, three-arm Phase 2 study evaluating Tedopi® in combination with docetaxel or the anti-PD1 immune checkpoint inhibitor nivolumab (Opdivo®), or docetaxel alone (reference arm) as second-line treatment in 106 HLA-A2 positive patients with metastatic NSCLC and no evidence of EGFR mutations or ALK or ROS1 rearrangement, after first-line chemo-immunotherapy. The primary endpoint was 1-year Overall Survival (OS) rate. The trial was conducted in 19 sites in France, Italy and Spain.
(NCT04884282).

The primary endpoint was met and results showed a statistically significant 1-year OS rate for both combinations of Tedopi® and docetaxel (OS = 47%; p = 0.001) and Tedopi® and nivolumab (OS = 46%; p = 0.002) but not for docetaxel alone (OS = 29%; p = 0.287).

Bayesian statistical analyses suggest a posterior probability >90% of improved 1-year OS versus docetaxel alone for both Tedopi®-based combinations.

Treatment-related adverse events occurred in 89% (Tedopi® + docetaxel), 82% (Tedopi® + nivolumab), and 79% (docetaxel alone) of patients. Drug-related serious adverse events were reported in 17% (Tedopi® + docetaxel), 24% (Tedopi® + nivolumab), and 17% (docetaxel alone) of patients. No unexpected safety signals were observed.

Final results will be presented on October 25, 2026, at the ESMO 2026 Annual Meeting in Madrid by Lead Investigator Federico Cappuzzo, MD, PhD. 

In addition, OSE will be hosting a KOL webcast on November 4, 2026, to discuss these results and how Tedopi® could benefit patients affected by NSCLC progressing after 1^st line chemo-immunotherapy with key opinion leaders Stephen Liu, MD (MedStar Georgetown University Hospital) and Federico Cappuzzo, MD, PhD (National Cancer Institute Regina Elena, Rome).

Silvia Comis, MD, Chief Clinical and Medical Research Officer, commented: “Tedopi-based combinations are encouraging supporting further evaluation of vaccine-based immunotherapy strategies in this setting. A Phase 3 registrational study of Tedopi monotherapy compared to docetaxel (ARTEMIA) is currently recruiting NSCLC patients with secondary resistance to immunotherapy, with results expected in early 2028.”