OSE Immunotherapeutics' Tedopi shows OS benefit in Phase 2 NSCLC trial

OSE Immunotherapeutics has presented final results from the Combi-TED Phase 2 trial of Tedopi (OSE2101) at the European Society for Medical Oncology Annual Meeting in Madrid, reporting that the neoantigen-based cancer vaccine improved 12-month overall survival rates when combined with either docetaxel or nivolumab in patients with metastatic non-small cell lung cancer.

The randomised, three-arm trial enrolled 106 HLA-A2 positive patients who had progressed after first-line chemo-immunotherapy. Participants received Tedopi alongside docetaxel (n=36), Tedopi alongside the anti-PD-1 checkpoint inhibitor nivolumab (n=35), or docetaxel alone as a reference arm (n=35). The primary endpoint was a one-year overall survival rate tested against a pre-specified 20% benchmark.

Trial data

Both combination arms met the primary endpoint with statistical significance. The Tedopi plus docetaxel arm achieved a 1-year OS rate of 47% (90% CI 33-62; p less than 0.001), and the Tedopi plus nivolumab arm reached 46% (90% CI 31-61; p less than 0.001). The docetaxel-alone reference arm returned 29% (90% CI 16-44; p=0.15), which did not meet the benchmark.

Median OS extended to 11.9 months for Tedopi plus docetaxel and 11.3 months for Tedopi plus nivolumab, compared with 6.4 months for docetaxel alone. Median progression-free survival was 4.8 months, 2.7 months, and 2.3 months across the three arms respectively. Objective response rate was 20% in the Tedopi plus docetaxel arm and 10% in the docetaxel-only arm; no responses were recorded in the Tedopi plus nivolumab arm.

A Bayesian exploratory analysis estimated a posterior probability of 94.6% and 92.8% that the two combination arms improve 1-year OS versus docetaxel alone. Although neither crossed the pre-defined 95% threshold selected to mirror a frequentist significance level, OSE characterised both figures as close to a highly demanding benchmark.

Treatment-related adverse events were observed in 89% of patients in the Tedopi plus docetaxel arm, 82% in the Tedopi plus nivolumab arm, and 79% in the reference arm. Serious drug-related adverse events occurred in 17%, 24%, and 17% of patients respectively. OSE said no unexpected safety signals were observed.

Federico Cappuzzo, Director of Medical Oncology at the National Cancer Institute Regina Elena in Rome and lead investigator, called the overall survival signal "strong," adding that the company may "finally" be positioned to outperform docetaxel in a population with high unmet need.

Market context and regulatory path

The second-line NSCLC setting remains fiercely competitive, populated by approved checkpoint inhibitors, antibody-drug conjugates, and targeted agents for driver-mutated subtypes. Tedopi targets HLA-A2 positive patients without EGFR, ALK, or ROS1 alterations, a biomarker-selected population that narrows the eligible pool but also offers a cleaner competitive niche. The Phase 2 dataset, while positive against its benchmark, is not a direct head-to-head comparison between arms; investors and clinicians will note this when judging how the results bear on the ongoing ARTEMIA Phase 3 trial, which is testing Tedopi as a monotherapy versus docetaxel.

Silvia Comis, Chief Clinical and Medical Research Officer at OSE, said the data support Tedopi's potential as a combination partner for a range of agents, including ADCs, tyrosine kinase inhibitors, and bispecific antibodies, across multiple tumour types and lines of treatment. That breadth of aspiration will need Phase 3 validation before commercial partners are likely to commit.

OSE will host a KOL webcast on 4 November 2026 to discuss the results with international clinical experts including Cappuzzo and Stephen Liu of MedStar Georgetown University Hospital.