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ESMO 2026 | Combi-TED: OSE2101 vaccine and docetaxel or nivolumab in pre-treated NSCLC

Federico Cappuzzo, MD, PhD, Istituto Nazionale Tumori IRCCS “Regina Elena”, Rome, Italy, discusses results from the Phase II Combi-TED (NCT04884282) trial evaluating the neo-epitope vaccine OSE2101 with docetaxel or nivolumab versus docetaxel alone in patients with HLA-A2-positive metastatic non-small cell lung cancer (NSCLC) progressing after first-line chemo-immunotherapy (chemo-IO). Both vaccine-based combinations met the predefined one-year overall survival threshold and showed a high probability of improved survival compared with docetaxel alone, without added toxicity or unexpected safety signals. These findings support further evaluation of vaccine-based immunotherapy in this setting. This interview took place at the European Society for Medical Oncology (ESMO) 2026 Congress in Madrid, Spain.

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Transcript

So the COMBITED trial that I presented yesterday is a randomized phase 2 trial in which patients with non – Non-Small Cell lung cancer HLA A2 positive relapsing after at least four cycles of chemo-immunotherapy were randomized to a vaccine, the name of this vaccine is Tedopi, together with docetaxel or nivolumab versus the standard arm of dose – taxel...
So the COMBITED trial that I presented yesterday is a randomized phase 2 trial in which patients with non – Non-Small Cell lung cancer HLA A2 positive relapsing after at least four cycles of chemo-immunotherapy were randomized to a vaccine, the name of this vaccine is Tedopi, together with docetaxel or nivolumab versus the standard arm of dose – taxel. The study was positive by showing that at one year the percentage of patients alive were 47 % with Tedopil plus docetaxel 46 % for Tedop in combination with nivolumab versus only 29 % for those patients that were treated with docetaxel alone. This is a very important result because this is very promising data supporting a further development of this vaccine that potentially could improve survival of patients in second-line setting that is a difficult to treat setting. i think that the the results of trials in a in second-line setting are just offering the opportunity of understanding that vaccine could play an important role in treating cancer in general and specifically, non-small cell lung cancer. Probably the best place for using this agent is when immune system is perfectly able to respond to the stimulation, so in early stage. But the signal that we have in a pre-treated patients reinforces certainly the hypothesis that this strategy is really effective in patients with non-small cell lung cancer and can potentially increase the curability of this disease.

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