1-year survival rate stands at 46–47%, compared to 29% for docetaxel monotherapy
Detailed results to be unveiled at ESMO on the 25th; pivotal Phase 3 monotherapy trial also underway
French biotechnology firm OSE Immunotherapeutics on October 19 (local time) released top-line results from the 'Combi-TED' Phase 2 clinical trial evaluating Tedopi in metastatic non-small cell lung cancer (NSCLC). The study, led by the Italian Foundation for Research on Cancer (FoRT), assessed a second-line treatment strategy administered after initial chemo-immunotherapy combination therapy. Detailed findings are scheduled for an oral presentation at the European Society for Medical Oncology annual congress (ESMO 2026) in Madrid, Spain, on the 25th.
Dr. Federico Cappuzzo, the principal investigator of the study, explained that docetaxel, commonly used as a second-line treatment, exhibits the toxicity profile of conventional chemotherapy while offering limited efficacy.
The trial enrolled 106 patients with HLA-A2 positive metastatic NSCLC lacking EGFR mutations or ALK/ROS1 gene rearrangements. Patients were randomized into three arms: Tedopi combined with the chemotherapy drug docetaxel, Tedopi combined with the immune checkpoint inhibitor nivolumab, and docetaxel monotherapy.
The primary endpoint, the 1-year overall survival (OS) rate, was 47% for the Tedopi-docetaxel combination arm, 46% for the Tedopi-nivolumab combination arm, and 29% for the docetaxel monotherapy arm. The two combination groups outperformed the monotherapy group by 18 percentage points and 17 percentage points, respectively.
According to the company, Bayesian statistical analysis indicated that the posterior probability of the 1-year survival rate being superior in the two combination arms compared to the docetaxel monotherapy arm exceeded 90% for both. However, as these are Phase 2 findings, further validation is required to confirm the efficacy of the combination regimens.
Treatment-related adverse events occurred in 89% of the Tedopi-docetaxel arm, 82% of the Tedopi-nivolumab arm, and 79% of the docetaxel monotherapy arm. Drug-related serious adverse events were reported in 17%, 24%, and 17% of patients in the respective groups. The company stated that no unexpected safety signals were observed.
Tedopi is a therapeutic vaccine designed to train the immune system to recognize and attack cancer cell antigens. It is developed by combining peptides derived from multiple tumor antigens to activate T-cell-mediated immune responses. In 2019, Chong Kun Dang entered into a licensing agreement with OSE for the domestic development, regulatory approval, and commercialization of the drug in South Korea.
The core of the regulatory development path remains monotherapy. Dr. Cappuzzo noted that Tedopi monotherapy has demonstrated signals of enhanced efficacy alongside superior safety and tolerability compared to docetaxel, prompting the design of the pivotal Phase 3 'ARTEMIA' trial for confirmation. ARTEMIA is a registrational clinical trial comparing Tedopi against docetaxel in HLA-A2 positive NSCLC patients who have developed secondary resistance to immunotherapy, with overall survival as the primary endpoint.
In a business update last month, OSE stated that the target enrollment for the ARTEMIA trial is set at 363 patients, with recruitment expected to conclude by the end of this year. During the October 19 presentation, the company projected trial results to be available in early 2028. Management noted that the latest combination trial results provide a rationale for further evaluating vaccine-based treatment strategies. While the Phase 3 monotherapy trial serves as the gateway for regulatory approval, the Phase 2 combination study offers clues for expanding Tedopi’s clinical utility.
