OSE Immunotherapeutics reported 47% one-year overall survival with Tedopi plus docetaxel in a Phase 2 metastatic lung cancer trial, while the nivolumab combination reached 46%.
The company said 29% of patients given docetaxel alone were alive at one year. OSE said both Tedopi combination arms met the primary endpoint, citing p-values of 0.001 for the docetaxel combination and 0.002 for the nivolumab combination; the docetaxel-only arm had a p-value of 0.287. The release did not identify the statistical test used for those values.
OSE said its Bayesian analyses put the posterior probability of improved one-year survival with each Tedopi combination, compared with docetaxel alone, above 90%. The published study-design abstract in the Journal of Clinical Oncology described Combi-TED as randomized but non-comparative, with one-year overall survival as its primary endpoint. The reported percentages therefore do not establish a statistically significant direct advantage over docetaxel.
Adverse events attributed to treatment affected 89% of patients in the Tedopi-docetaxel group, 82% in the Tedopi-nivolumab group and 79% in the docetaxel-only arm. Serious drug-related events were recorded in 17%, 24% and 17%, respectively. OSE reported no safety findings it considered unexpected.
The trial addressed second-line treatment for patients whose disease progressed after first-line chemo-immunotherapy. OSE said its 106 participants had HLA-A2-positive metastatic non-small cell lung cancer and no EGFR mutations or ALK or ROS1 rearrangements. The open-label, three-arm study ran at 19 sites in France, Italy and Spain, with FoRT (Fondazione Ricerca Traslazionale) as sponsor.
Combi-TED lead investigator Federico Cappuzzo, MD, Ph.D., said docetaxel remains his second-line option for these patients, although he considers its efficacy limited. OSE said results from ARTEMIA, a separate Phase 3 study of Tedopi alone versus docetaxel for secondary immunotherapy resistance, are expected in early 2028.
OSE said Cappuzzo is scheduled to present the Combi-TED findings Sunday, Oct. 25, from 3:30 to 5 a.m. ET (07:30–09:00 UTC) at the European Society for Medical Oncology meeting in Madrid. The company also plans a webcast Nov. 4 at 11 a.m. ET.
