Sparks - OSE Immunotherapeutics

OSE Immunotherapeutics has reported final results from the Phase II Combi-TED study of cancer vaccine Tedopi in second line metastatic non-small cell lung cancer (NSCLC), providing further evidence of its potential in combination regimens. Following the previously disclosed positive one year survival data, the latest readout shows median overall survival (OS) of 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 (PFS), measuring the time before disease progression or death, was 4.8, 2.7, and 2.3 months, respectively, suggesting a more pronounced benefit with the docetaxel combination. This was supported by objective response rates of 20% with Tedopi plus docetaxel versus 10% with docetaxel alone, while no responses were observed with the nivolumab combination.

Exploratory Bayesian analyses estimated probabilities of improved one year OS versus docetaxel alone of 94.6% and 92.8% for the respective combinations, narrowly missing the predefined 95% threshold for supporting progression to Phase III. We note that the study’s primary endpoint p values reflect comparisons against a predefined 20% survival benchmark, rather than statistically significant differences between treatment arms.

No unexpected safety signals emerged, consistent with the earlier top line findings. We view the additional data as encouraging for Tedopi’s combination potential, particularly with docetaxel, although the modest sample sizes (35 to 36 patients per arm) warrant caution when interpreting comparative outcomes.

Investor attention now turns to the key opinion leader webcast on 4 November 2026 and the ongoing Phase III ARTEMIA study, which remains the registrational test of Tedopi as a monotherapy against docetaxel, with an OS readout expected in Q128.