OSE Immunotherapeutics: Tedopi Achieves Primary Survival Endpoint in Phase 2 Lung Cancer Trial
OSE Immunotherapeutics unveiled on October 19, 2026 the initial results of the Combi-TED phase 2 trial, through an abstract selected for oral presentation at the ESMO annual congress. Both combinations pairing Tedopi (OSE2101) with docetaxel or nivolumab achieved the primary efficacy endpoint of one-year overall survival, with respective rates of 47% and 46%, compared to 29% for docetaxel alone.
These data emerge as the Nantes-based biotech indicated on September 28, 2026 that it held cash reserves funded through the end of 2026 and was pursuing discussions with institutional investors in the United States and Europe to extend this horizon. The announcement also reports higher rates of adverse events in the combination arms than in the reference arm.
One-Year Survival of 47% and 46% with Tedopi, Versus 29% with Docetaxel Alone
Combi-TED is an international academic study promoted by the Italian foundation FoRT and conducted across 19 centers in France, Italy and Spain. It enrolled 106 HLA-A2 positive patients with metastatic non-small cell lung cancer, without EGFR mutations or ALK or ROS1 rearrangements, treated in second line following first-line chemo-immunotherapy.
The randomized, open-label trial compared three arms: Tedopi combined with docetaxel, Tedopi combined with the anti-PD1 nivolumab (Opdivo), and docetaxel alone as reference arm. One-year overall survival rate was 47% for the combination with docetaxel (p = 0.001) and 46% for the combination with nivolumab (p = 0.002), both statistically significant results. The docetaxel-alone arm achieved 29%, a non-significant result (p = 0.287).
For comparison with docetaxel alone, the announcement mentions Bayesian statistical analyses suggesting a posterior probability exceeding 90% of improved one-year overall survival for each of the two combinations. The principal investigator, Prof. Federico Cappuzzo (Istituto Nazionale Tumori Regina Elena, Rome), estimates that the team has "practically doubled one-year survival".
Adverse Events More Frequent with Both Combinations
In terms of tolerability, treatment-related adverse events were observed in 89% of patients in the Tedopi and docetaxel arm, 82% in the Tedopi and nivolumab arm and 79% in the docetaxel-alone arm. Treatment-related serious adverse events affected 17% of patients in the Tedopi and docetaxel arm, 24% in the Tedopi and nivolumab arm and 17% in the reference arm.
The rate of serious events is therefore identical between the combination with docetaxel and docetaxel alone, and seven percentage points higher in the combination with nivolumab. According to the announcement, no unexpected safety signals were observed.
Several characteristics of the study should be considered when interpreting these figures: this is a phase 2 open-label trial conducted in 106 patients distributed across three arms. The published data are preliminary results: definitive results are to be presented on October 25, 2026 in Madrid.
ESMO Presentation on October 25, ARTEMIA Results Expected Early 2028
Prof. Federico Cappuzzo will present the results at the ESMO annual congress in Madrid on October 25, 2026. The company will subsequently host, on November 4, 2026, a webcast with Dr. Stephen Liu (MedStar Georgetown University Hospital) and Prof. Cappuzzo. These milestones are added to the management's participation, announced on October 15, 2026, in the healthcare conference organized by Chardan in New York on October 20.
Combi-TED evaluates Tedopi in combination, while the regulatory development of the product relies on another study. The ARTEMIA phase 3 registration trial, which compares Tedopi as monotherapy to docetaxel in patients with secondary immunotherapy resistance, is currently recruiting.
For Dr. Silvia Comis, Director of Clinical and Medical Research, the combinations with Tedopi "encourage us to continue evaluating vaccine immunotherapy strategies in this clinical setting". According to the company, ARTEMIA results are expected in early 2028.
