Nantes, France — October 29, 2026
OSE Immunotherapeutics SA reported final positive results from its Combi-TED Phase 2 randomized clinical trial, evaluating Tedopi® (OSE2101) in combination with chemotherapy or immunotherapy for patients with metastatic non-small cell lung cancer (NSCLC). The findings were presented by lead investigator Federico Cappuzzo, MD, PhD, at the 2026 European Society for Medical Oncology (ESMO) Annual Meeting in Madrid on October 25. Sponsored by the Fondazione Ricerca Traslazionale (FoRT), the international study evaluated Tedopi in 106 patients receiving second-line treatment after first-line chemo-immunotherapy. The primary endpoint was achieved in both experimental treatment arms, with 12-month overall survival (OS) rates of 47% for Tedopi plus docetaxel and 46% for Tedopi plus nivolumab, compared with 29% for docetaxel alone. The company said the results provide additional clinical evidence supporting further investigation of Tedopi in this difficult-to-treat patient population.
Combi-TED Trial Design and Primary Endpoint
The open-label, randomized, three-arm Phase 2 study (NCT04884282) enrolled 106 HLA-A2-positive patients with metastatic NSCLC without EGFR mutations or ALK or ROS1 rearrangements. Participants were assigned to Tedopi plus docetaxel (n=36), Tedopi plus the anti-PD-1 checkpoint inhibitor nivolumab (Opdivo®) (n=35), or docetaxel alone (n=35). The trial was conducted at 19 sites across France, Italy and Spain. Treatments were administered every three weeks for up to six cycles. Docetaxel was dosed at 60 mg/m² in the Tedopi combination arm and 75 mg/m² in the reference arm. From cycle seven, Tedopi was administered every six weeks until month 12 and every 12 weeks thereafter, while nivolumab continued every three weeks in its combination arm. The primary endpoint was the 12-month overall survival rate. Each treatment arm was assessed against a predefined 20% survival benchmark using a one-sided exact binomial test at a 5% significance level. Accordingly, the reported p-values represent comparisons against that benchmark, not direct statistical comparisons between treatment arms.
Survival Outcomes and Exploratory Analyses
The final results showed 12-month OS rates of 47% (17/36 patients) for Tedopi plus docetaxel (90% CI: 33–62; p<0.001) and 46% (16/35 patients) for Tedopi plus nivolumab (90% CI: 31–61; p<0.001). The docetaxel-alone arm recorded a 12-month OS rate of 29% (10/35 patients) (90% CI: 16–44; p=0.15), which did not meet the predefined statistical threshold. Median OS was 11.9 months with Tedopi plus docetaxel, 11.3 months with Tedopi plus nivolumab and 6.4 months with docetaxel alone. Median progression-free survival was 4.8, 2.7 and 2.3 months, respectively. The objective response rate was 20% for Tedopi plus docetaxel and 10% for docetaxel alone; no responses were reported in the nivolumab combination arm. An exploratory Bayesian analysis estimated a 94.6% posterior probability of improved 12-month OS for Tedopi plus docetaxel and 92.8% for Tedopi plus nivolumab versus docetaxel alone. Both estimates favored the combinations but remained below the trial’s predefined 95% threshold for classifying a combination as promising for Phase 3 development. The company emphasized that this analysis was exploratory and intended to support decision-making in a study with a limited sample size.
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Safety Profile and Further Clinical Development
Treatment-related adverse events occurred in 89% of patients receiving Tedopi plus docetaxel, 82% receiving Tedopi plus nivolumab and 79% receiving docetaxel alone. Drug-related serious adverse events were reported in 17%, 24% and 17% of patients, respectively. No unexpected safety signals were observed. OSE Immunotherapeutics stated that the findings support continued investigation of Tedopi in combination with different treatment approaches, while its ongoing ARTEMIA Phase 3 trial is evaluating Tedopi monotherapy against docetaxel. The company also highlighted potential combinations with other chemotherapy agents and immunotherapies, although these possibilities require further clinical evaluation. OSE will host a key opinion leader (KOL) webcast on November 4, 2026, at 5:00 p.m. CET (11:00 a.m. ET), featuring Stephen Liu, MD, of MedStar Georgetown University Hospital and Federico Cappuzzo, MD, PhD, to discuss the Combi-TED findings and Tedopi’s potential role in NSCLC treatment. The final results provide encouraging survival signals, but the study’s size and statistical design should be considered when interpreting the findings.
Source:OSE Immunotherapeutics Press release
