OSE Immunotherapeutics has reported positive topline results from Combi-TED, an academic Phase 2 trial of its cancer vaccine Tedopi (OSE2101) in metastatic non small cell lung cancer, released on October 19 as the abstract selected for oral presentation at the ESMO congress in Madrid. The trial’s primary endpoint, one year overall survival, was met for both Tedopi combinations: 47 percent for Tedopi plus docetaxel (p=0.001) and 46 percent for Tedopi plus the anti PD1 nivolumab (p=0.002), against 29 percent for docetaxel alone (p=0.287). Bayesian analyses put the posterior probability of improved one year survival over docetaxel alone above 90 percent for both combinations.
Combi-TED was an open label, randomised, three arm study in 106 HLA-A2 positive patients with metastatic disease, no EGFR, ALK or ROS1 alterations, whose cancer had progressed after first line chemo immunotherapy. It ran at 19 sites in France, Italy and Spain and was sponsored by the FoRT foundation. Lead investigator Federico Cappuzzo of Rome’s National Cancer Institute Regina Elena said the combinations almost doubled survival at one year in a setting where docetaxel, with its chemotherapy toxicity and limited efficacy, remains the only standard option.
Safety was in line with the components. Treatment related adverse events occurred in 89 percent of the Tedopi plus docetaxel arm, 82 percent of the Tedopi plus nivolumab arm and 79 percent on docetaxel alone, with drug related serious adverse events in 17, 24 and 17 percent respectively, and no unexpected signals.
The limits are scale and design: 106 patients, an open label academic trial, and a one year survival rate endpoint rather than a powered survival comparison. The registrational question sits with ARTEMIA, OSE’s Phase 3 trial of Tedopi monotherapy against docetaxel in patients with secondary resistance to immunotherapy, now recruiting with results expected in early 2028. Full Combi-TED results are presented at ESMO on October 25.