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OSE Immunotherapeutics Phase 2 Trial Meets Main Goal in Lung Cancer Study

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OSE Immunotherapeutics SA (OSE) reported positive top-line results from its Phase 2 Combi-TED trial evaluating Tedopi combination therapies in non-small cell lung cancer. The study met its primary endpoint of improving one-year overall survival, with combination treatments outperforming single-agent chemotherapy.

In the trial, patients receiving Tedopi combined with docetaxel achieved a 47% one-year overall survival rate, while those given Tedopi with nivolumab reached 46%. Both combination arms demonstrated statistically significant improvements over docetaxel alone, which recorded a 29% survival rate. Bayesian analysis showed a greater than 90% posterior probability of improved survival over control. Safety outcomes met expectations, with no unexpected signals and adverse events occurring in 82% to 89% of patients in the combination arms.

Final trial findings are scheduled for presentation on October 25, 2026, at the ESMO conference. Investors are also following progress in the company's ongoing Phase 3 ARTEMIA trial, which studies Tedopi as a single-agent treatment. Shares of OSE Immunotherapeutics SA fell 4.34% to 2.16 EUR following the announcement.

Key points

  • OSE Immunotherapeutics met its primary endpoint in the Phase 2 Combi-TED study in non-small cell lung cancer.
  • One-year overall survival reached 47% for Tedopi with docetaxel and 46% with nivolumab, compared to 29% for docetaxel alone.
  • No unexpected safety signals were identified, with adverse events reported in 82% to 89% of combination patients.
  • Final trial results will be presented on October 25, 2026, at the ESMO medical conference.

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Questions and answers

What were the Phase 2 trial results for OSE Immunotherapeutics?

The trial met its primary endpoint, showing one-year overall survival rates of 47% for Tedopi with docetaxel and 46% with nivolumab, versus 29% for chemotherapy alone.

When will full trial data for Tedopi be presented?

Full data from the Phase 2 Combi-TED trial will be presented on October 25, 2026, at the ESMO conference.

Were there any safety concerns in the Combi-TED study?

No unexpected safety signals were observed. Side effects occurred in 82% to 89% of patients receiving the combination treatments.