OSE Immunotherapeutics Combi-TED Phase 2 Shows Tedopi Survival Gain in Metastatic NSCLC

OSE Immunotherapeutics said on October 19, 2026 that its Combi-TED Phase 2 trial of Tedopi (OSE2101) in metastatic non-small cell lung cancer met its primary endpoint, with a 1-year overall survival rate of 47% for Tedopi plus docetaxel and 46% for Tedopi plus nivolumab, against 29% for docetaxel alone. The lead report was published by TradingView.

How the Combi-TED Trial Was Designed

Combi-TED is an open label, randomized, three-arm Phase 2 study testing Tedopi with docetaxel or with the anti-PD1 immune checkpoint inhibitor nivolumab (Opdivo), or docetaxel alone as the reference arm, as second-line treatment. It enrolled 106 HLA-A2 positive patients with metastatic NSCLC and no evidence of EGFR mutations or ALK or ROS1 rearrangement, after first-line chemo-immunotherapy, across 19 sites in France, Italy and Spain.

The primary endpoint was the 1-year overall survival rate. The company said the endpoint was met, with a statistically significant rate for Tedopi plus docetaxel (47%; p = 0.001) and for Tedopi plus nivolumab (46%; p = 0.002), but not for docetaxel alone (29%; p = 0.287). Bayesian statistical analyses suggest a posterior probability above 90% of improved 1-year overall survival versus docetaxel alone for both Tedopi-based combinations.

Treatment-related adverse events occurred in 89% of patients on Tedopi plus docetaxel, 82% on Tedopi plus nivolumab and 79% on docetaxel alone. Drug-related serious adverse events were reported in 17%, 24% and 17% of patients respectively, and the company 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 of the trial, said: "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."

OSE Immunotherapeutics' Funding and Pipeline Record

According to akta.pro company records, OSE Immunotherapeutics signed a flexible equity bridge financing (SmartATM) with IRIS Capital Investment in May 2026 for up to €19.3 million in gross proceeds via 4,000,000 warrants at a 5% discount over 24 months, extending its cash runway to end-December 2026. The same records list total potential partnership revenue of up to €2.1 billion from all existing partnerships, with €219 million already received.

OSE Immunotherapeutics is a French clinical-stage biotech developing immunotherapies in immuno-oncology and immuno-inflammation, led by the Phase 3 cancer vaccine Tedopi, with revenue generated primarily through licensing deals with AbbVie, Boehringer Ingelheim and Veloxis.

Earlier Tedopi Results and Presentations

On September 23, 2026, OSE Immunotherapeutics announced that Combi-TED Phase 2 topline results would be presented at ESMO 2026 in Madrid, according to FinancialContent Business Page. That summary described the trial as evaluating Tedopi plus nivolumab or docetaxel as second-line therapy in 105 HLA-A2 positive patients.

On May 22, 2026, OSE Immunotherapeutics reported positive topline results from the TEDOVA Phase 2 trial of Tedopi as a maintenance treatment for platinum-sensitive recurrent ovarian cancer, sponsored by ARCAGY-GINECO, Yahoo reported. On September 28, 2026, the company reported €11.1 million in cash as of June 30, 2026, with a runway to December 2026 via bridge financing, and deferred its H1 2026 financial results, according to FinancialContent Business Page.

ESMO Presentation and Webcast Dates

Final Combi-TED results will be presented on October 25, 2026, at the ESMO 2026 Annual Meeting in Madrid by lead investigator Federico Cappuzzo. OSE Immunotherapeutics will host a KOL webcast on November 4, 2026, to discuss the results with Stephen Liu of MedStar Georgetown University Hospital and Federico Cappuzzo. Silvia Comis, Chief Clinical and Medical Research Officer, said 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.