OSE Immunotherapeutics reports 46%–47% one-year survival with Tedopi combinations in the Combi-TED Phase 2 trial in metastatic NSCLC.
Written By: Khushi Patel, PharmD
Reviewed By: Pharmacally editorial Team
OSE Immunotherapeutics has reported positive topline results from the Combi-TED Phase 2 trial, in which combinations of its investigational therapeutic cancer vaccine Tedopi® (OSE2101) with docetaxel or nivolumab achieved one-year overall survival (OS) rates of 47% and 46%, respectively, in patients with metastatic non-small cell lung cancer (NSCLC) progressing after first-line chemoimmunotherapy.
The company reported that the trial met its primary endpoint. The findings support further evaluation of vaccine-based treatment strategies in this setting, where therapeutic options following progression on chemoimmunotherapy remain limited.
Combi-TED Trial Design and Patient Population
Combi-TED (NCT04884282) was an open-label, randomized, three-arm Phase 2 study sponsored by Fondazione Ricerca Traslazionale (FoRT). It enrolled 106 patients with metastatic NSCLC who tested positive for HLA-A2 and had no evidence of EGFR mutations or ALK or ROS1 rearrangements. All participants had experienced disease progression following first-line chemoimmunotherapy.
Patients received Tedopi plus docetaxel, Tedopi plus nivolumab, or docetaxel alone as second-line treatment. The study was conducted at 19 sites across France, Italy and Spain. One-year OS rate was the primary endpoint.
One-Year Survival Results Favor Tedopi-Based Combinations
According to the topline announcement, the Tedopi plus docetaxel arm achieved a one-year OS rate of 47% (p=0.001), while the Tedopi plus nivolumab arm recorded 46% (p=0.002). The docetaxel-alone reference arm had a one-year OS rate of 29% (p=0.287).
The observed differences were 18 percentage points for Tedopi plus docetaxel and 17 percentage points for Tedopi plus nivolumab relative to docetaxel alone. Bayesian analyses reported by the company indicated a posterior probability greater than 90% that each Tedopi-based combination improved one-year survival compared with the reference arm.
These findings are encouraging, but the topline announcement does not provide confidence intervals or sufficient detail on the statistical testing framework to independently assess the precision of the treatment differences. The reported p-values should therefore be interpreted within the trial’s prespecified analysis rather than as standalone proof of definitive comparative superiority.
Safety Findings Across Treatment Arms
Treatment-related adverse events occurred in 89% of patients receiving Tedopi plus docetaxel, 82% receiving Tedopi plus nivolumab, and 79% receiving docetaxel alone. Drug-related serious adverse events were reported in 17%, 24% and 17% of patients, respectively.
OSE Immunotherapeutics reported no unexpected safety signals. However, these topline percentages do not establish equivalent safety profiles across the treatment arms. Further information on adverse-event severity, specific toxicities, treatment discontinuations and exposure duration would help clarify the benefit-risk profile of each combination.
Tedopi’s Mechanism and HLA-A2 Selection
Tedopi is an investigational therapeutic cancer vaccine comprising 10 modified neoepitopes derived from five tumor-associated antigens: CEA, HER2, MAGE-2, MAGE-3 and p53. It is designed to stimulate cytotoxic T cells that recognize tumor cells presenting these antigens in the context of HLA-A2.
The trial’s restriction to HLA-A2-positive patients is therefore central to interpreting its results. The findings apply to the selected study population and should not automatically be generalized to patients with other HLA phenotypes.
The results also build on earlier investigations of Tedopi monotherapy, including the ATALANTE-1 Phase 3 trial, which evaluated the vaccine in patients with advanced NSCLC after checkpoint inhibitor treatment. Combi-TED, however, evaluated combination regimens and does not independently confirm the efficacy of Tedopi monotherapy.
ARTEMIA Phase 3 Trial Remains Important
OSE Immunotherapeutics is advancing Tedopi monotherapy in ARTEMIA, a Phase 3 registrational study comparing the vaccine with docetaxel in patients with NSCLC and secondary resistance to immunotherapy. The company expects results in early 2028.
The Combi-TED topline findings will be presented by lead investigator Federico Cappuzzo, MD, PhD, at the European Society for Medical Oncology (ESMO) 2026 Annual Meeting in Madrid on October 25. The company has also scheduled a key opinion leader webcast for November 4.
Clinical interpretation
Combi-TED provides an encouraging Phase 2 signal for combining Tedopi with chemotherapy or checkpoint inhibition after first-line chemoimmunotherapy. The observed one-year survival rates warrant further assessment, but the magnitude and clinical relevance of the treatment differences require interpretation alongside the full trial data. ARTEMIA remains a separate and important test of Tedopi monotherapy, and the Combi-TED findings alone do not establish a new standard of care.
References
OSE Immunotherapeutics Reports Positive Topline Results of Combi-TED Phase 2 Randomized Trial with Tedopi® (OSE2101) in metastatic Non-Small Cell Lung Cancer, OSE Immunotherapeutics, 19 October 2026
Efficacy of Tedopi Plus Docetaxel or Tedopi Plus Nivolumab as Second-line Therapy in Metastatic Non-small-cell Lung Cancer Progressing After First-line Chemo-immunotherapy (Combi-TED) (COMBI-TED), ClinicalTrials.gov ID NCT04884282
About the Writer
Khushi Patel is a Pharm.D (Linkedin) professional with a strong foundation in clinical pharmacy, patient-centered care, regulatory affairs, and pharmacovigilance, with published work on Brugada syndrome.
Her interests include regulatory affairs, pharmacovigilance, guideline integration, multimodal therapy, pharmacogenomics, and antibiogram utilization, with a focus on evidence-based clinical decision-making and medication safety.
As a Pharmacally healthcare writer, she translates clinical and scientific evidence into clear, accurate, and clinically relevant healthcare content, while continuously developing her expertise in evolving pharmacy practice.