OSE Immunotherapeutics reports encouraging Phase 2 Combi-TED survival results for Tedopi combinations in previously treated metastatic NSCLC.
Written By: Neha Vishwakarma, PharmD
Reviewed By: Pharmacally Editorial Team
OSE Immunotherapeutics reported final results from its Combi-TED Phase 2 trial on October 29, 2026, evaluating Tedopi (OSE2101) in combination with docetaxel or nivolumab in patients with previously treated metastatic non-small cell lung cancer (NSCLC). Presented by lead investigator Federico Cappuzzo, MD, PhD, at the European Society for Medical Oncology (ESMO) 2026 Annual Meeting on October 25, the results showed encouraging overall survival (OS) signals with both combinations.
One-year OS rates were 47% with Tedopi plus docetaxel and 46% with Tedopi plus nivolumab, compared with 29% with docetaxel alone. Median OS reached 11.9, 11.3 and 6.4 months, respectively. However, the trial was not designed to establish direct statistical superiority of either combination over docetaxel.
Addressing the need after first-line chemo-immunotherapy
Patients with metastatic NSCLC who progress following first-line chemo-immunotherapy have limited subsequent treatment options. Docetaxel remains an established second-line treatment, although its clinical benefit can be modest.
Tedopi is an off-the-shelf therapeutic cancer vaccine designed to stimulate T-cell responses against tumour-associated antigens. It is developed for HLA-A2-positive patients. Combi-TED investigated whether combining the vaccine with chemotherapy or immune checkpoint inhibition could improve outcomes in this treatment setting.
The academic study was sponsored by Fondazione Ricerca Traslazionale (FoRT).
Combi-TED trial design
Combi-TED (NCT04884282) was an open-label, randomised, three-arm Phase 2 study conducted across 19 sites in France, Italy and Spain. It enrolled 106 HLA-A2-positive patients with metastatic NSCLC without EGFR mutations or ALK or ROS1 rearrangements, whose disease had progressed following first-line chemo-immunotherapy.
Patients received one of three regimens:
- Tedopi plus docetaxel (n=36).
- Tedopi plus nivolumab (n=35).
- Docetaxel alone (n=35).
Treatment was administered every three weeks for up to six cycles. Docetaxel was dosed at 60 mg/m² in the Tedopi combination arm and 75 mg/m² in the reference arm. Tedopi continued every six weeks from cycle seven, followed by administration every 12 weeks after 12 months. Nivolumab continued every three weeks in its combination arm.
The primary endpoint was one-year OS. Each arm was tested against a predefined 20% survival benchmark using a one-sided exact binomial test. Secondary endpoints included median OS, progression-free survival (PFS), objective response rate (ORR) and safety.
Survival results favour both Tedopi combinations
Both experimental combinations achieved statistically significant one-year OS rates against the predefined benchmark.
One-year OS was 47% (17/36; 90% CI 33–62; p<0.001) with Tedopi plus docetaxel and 46% (16/35; 90% CI 31–61; p<0.001) with Tedopi plus nivolumab. The docetaxel-alone arm achieved 29% (10/35; 90% CI 16–44; p=0.15).
Median OS was 11.9 months (90% CI 8.9–15.3) with Tedopi plus docetaxel, 11.3 months (90% CI 6.1–13.3) with Tedopi plus nivolumab and 6.4 months (90% CI 5.2–9.0) with docetaxel alone.
Exploratory Bayesian analyses estimated a 94.6% posterior probability of improved one-year OS versus docetaxel alone for the docetaxel combination and 92.8% for the nivolumab combination. Both fell short of the predefined 95% threshold for classifying a regimen as promising.
Secondary efficacy and safety findings
Median PFS was 4.8 months with Tedopi plus docetaxel, 2.7 months with Tedopi plus nivolumab and 2.3 months with docetaxel alone. ORR was 20% and 10% in the respective docetaxel combination and monotherapy arms, while no objective responses were reported with Tedopi plus nivolumab.
Treatment-related adverse events occurred in 89%, 82% and 79% of patients across the three arms, respectively. Drug-related serious adverse events were reported in 17%, 24% and 17%.
No unexpected safety signals were reported. However, the higher incidence of serious adverse events with Tedopi plus nivolumab warrants attention alongside its limited PFS and absence of objective responses.
Clinical interpretation and next development steps
The principal finding is the difference in observed median OS between the Tedopi combinations and docetaxel alone. Both combinations produced survival signals in a difficult second-line treatment setting, with median OS exceeding 11 months. However, these findings require cautious interpretation.
The primary statistical analysis tested each arm against a fixed 20% survival benchmark rather than directly comparing the treatment groups. Although the docetaxel-alone arm did not achieve statistical significance against this benchmark, its one-year OS rate was still 29%. The small sample size, overlapping confidence intervals and different docetaxel doses further limit conclusions about comparative efficacy.
The nivolumab combination also presents an important clinical question: its median OS was 11.3 months despite a median PFS of 2.7 months and no objective responses. Further investigation will be needed to understand this difference.
OSE is advancing Tedopi as monotherapy in the ongoing Phase 3 ARTEMIA trial, which compares Tedopi with docetaxel. The study is recruiting, with results expected in early 2028 according to the company’s earlier announcement.
Combi-TED therefore provides additional clinical evidence supporting investigation of Tedopi-based combinations, but it does not establish a survival advantage over docetaxel. The ARTEMIA study will be important in determining whether Tedopi can demonstrate comparative efficacy as a standalone treatment. Tedopi remains investigational.
Reference
OSE Immunotherapeutics Reports Additional Positive Results of Combi-TED Phase 2 Randomized Trial with Tedopi® (OSE2101) in metastatic Non-Small Cell Lung Cancer, 29 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
Neha Vishwakarma (LinkedIn) is a Pharm.D professional with experience in clinical pharmacy, pharmacovigilance, and clinical research. She has hands-on experience in ADR assessment, ICSR processing, medication safety, and clinical data evaluation. Her research background in surgical site infections and antibiotic use supports her focus on evidence-based healthcare writing.