OSE Immunotherapeutics: Combi-TED meets its objective, not the Bayesian threshold
OSE Immunotherapeutics published on October 29, 2026 the full results of the Combi-TED trial, presented at the annual ESMO congress. They confirm the achievement of the primary endpoint announced on October 19 and detail secondary data that differ between the two combinations tested in 106 patients.
One-year survival: 47% and 46% against a 20% threshold
Sponsored by the FoRT foundation, this open-label, three-arm randomized phase 2 study evaluated Tedopi (OSE2101) combined with docetaxel or nivolumab, versus docetaxel alone. The patients, HLA-A2 positive, had metastatic non-small cell lung cancer treated in second line after chemo-immunotherapy.
The one-year overall survival rate reached 47% with docetaxel and 46% with nivolumab (p < 0.001 in both cases), compared with 29% for docetaxel alone (p = 0.15). These p-values refer to the prespecified 20% threshold, not to direct comparisons between arms.
Median overall survival was 11.9 months and 11.3 months for the two combinations, compared with 6.4 months for docetaxel alone. Prof. Federico Cappuzzo, principal investigator, sees in it “a strong signal suggesting that it may finally be possible to obtain results superior to those of docetaxel in this difficult-to-treat population”.
Bayesian threshold narrowly missed, no response in the nivolumab arm
The exploratory Bayesian analysis set a 95% threshold for qualifying a combination as “promising” for a phase 3 study. It yields a probability of improvement in one-year survival of 94.6% for the combination with docetaxel and 92.8% with nivolumab: neither reaches this prespecified threshold.
On secondary endpoints, median progression-free survival was 4.8 months with docetaxel, 2.7 months with nivolumab and 2.3 months with monotherapy. The objective response rate is 20% for the combination with docetaxel and 10% for docetaxel alone; no response was reported in the nivolumab arm.
Regarding tolerability, treatment-related serious adverse events were reported in 24% of patients in the nivolumab arm, compared with 17% in each of the other two arms. The company indicates that no unexpected safety signal was observed.
For Dr Silvia Comis, Director of Clinical and Medical Research, Tedopi “could therefore become a key partner for many other assets”. The product is also being evaluated alone against docetaxel in the ongoing phase 3 ARTEMIA study, and OSE will bring together experts on November 4, 2026 during an online conference.
