NANTES, France — September 23, 2026
OSE Immunotherapeutics announced that topline results from the Combi-TED Phase 2 trial of Tedopi® (OSE2101) in metastatic non-small cell lung cancer (NSCLC) have been selected for an oral presentation at the ESMO 2026 Congress in Madrid. The randomized Phase 2 study is evaluating Tedopi in combination with the anti-PD-1 therapy nivolumab or with docetaxel, compared with docetaxel alone, as second-line treatment for patients whose metastatic NSCLC progressed following first-line chemo-immunotherapy. The topline findings will be presented by Federico Cappuzzo, MD, PhD, lead investigator of the study, on October 25, 2026.
Combi-TED Evaluates Tedopi in Second-Line NSCLC
The Combi-TED trial is an open-label, randomized, three-arm Phase 2 study enrolling 105 HLA-A2-positive patients with metastatic NSCLC. Eligible patients have no evidence of EGFR mutations or ALK or ROS1 rearrangements and have experienced disease progression after first-line chemo-immunotherapy. Participants are randomized to Tedopi plus nivolumab, Tedopi plus docetaxel, or docetaxel alone as the reference arm. The primary endpoint is one-year survival rate, with the study designed to evaluate the potential of Tedopi-based combinations in a population with limited treatment options following initial chemo-immunotherapy.
Tedopi Combines Multi-Epitope Immunotherapy With Checkpoint Inhibition
Tedopi is an investigational cancer vaccine based on a combination of nine HLA-A2-restricted tumor-associated antigen-derived peptides, designed to stimulate tumor-specific cytotoxic T-cell responses. In the Combi-TED program, OSE is evaluating whether combining this immune response with nivolumab or chemotherapy can provide therapeutic activity in metastatic NSCLC. The study is being conducted across 23 clinical sites in France, Italy and Spain and is sponsored by FoRT, with the trial registered as NCT04884282.
Advertisement
OSE Prepares ESMO 2026 Combi-TED Data Presentation
The Combi-TED topline results will be presented as a Rapid Oral Presentation in the Metastatic Non-Small Cell Lung Cancer session at ESMO 2026. The presentation is scheduled for October 25, 2026, from 8:30 to 10:00 a.m. CET in the Barcelona Auditorium, Hall 9, under Abstract 2661RO. The upcoming data will provide a clinical assessment of Tedopi-based second-line combinations following first-line chemo-immunotherapy and represent an important milestone in OSE Immunotherapeutics’ immuno-oncology development strategy.
Source :OSE Immunotherapeutics press release
