Cancer Vaccine Combinations Improve 1-Year Survival in Second-Line NSCLC

The off-the-shelf therapeutic cancer vaccine OSE2101 (Tedopi), combined with either docetaxel or the anti–PD-1 immune checkpoint inhibitor nivolumab (Opdivo), met the primary end point of 1-year overall survival (OS) rate as a second-line treatment for patients with metastatic non–small cell lung cancer (NSCLC) in the phase 2 Combi-TED trial (NCT04884282), according to topline results announced by the developer, OSE Immunotherapeutics.¹

What were the key survival outcomes?

The trial met its primary end point of 1-year OS rate, which was 47% with OSE2101 plus docetaxel (P = .001) and 46% with OSE2101 plus nivolumab (P = .002), compared with 29% for docetaxel alone (P = .287), which did not reach statistical significance. Bayesian statistical analyses suggested a posterior probability greater than 90% for improved 1-year OS vs docetaxel alone for both OSE2101-based combinations.

“In Combi-TED, we almost doubled the survival at 1 year with [OSE2101] combined with either chemotherapy docetaxel or immunotherapy nivolumab, an extremely encouraging result that represents a new step forward in the treatment strategy for patients with progressive NSCLC,” said lead investigator Federico Cappuzzo, MD, PhD, director of medical oncology at the National Cancer Institute Regina Elena in Rome, Italy, in the news release.¹

What was the safety profile?

Treatment-related adverse events occurred in 89% of patients in the OSE2101 plus docetaxel arm, 82% in the OSE2101 plus nivolumab arm, and 79% in the docetaxel-alone arm. Drug-related serious adverse events were reported in 17%, 24%, and 17% of patients, respectively. No unexpected safety signals were observed.

Cappuzzo noted that docetaxel remains the primary second-line option in current practice despite the toxicity of chemotherapy and limited efficacy, and that OSE2101 monotherapy “has already shown signs of superiority compared to docetaxel in terms of efficacy associated with a better safety and tolerability profile.”¹

How was the Combi-TED trial designed?

Combi-TED is an open-label, randomized, 3-arm phase 2 study evaluating OSE2101 in combination with docetaxel or nivolumab, or docetaxel alone as the reference arm, as second-line treatment of 106 patients with metastatic HLA-A2–positive NSCLC and no evidence of EGFR mutations or ALK or ROS1 rearrangements who had progressed after first-line chemoimmunotherapy.² The primary end point was the 1-year OS rate.

Patients 18 years and older with histologically or cytologically confirmed HLA-A2–positive disease, evidence of disease progression after at least 4 cycles of chemoimmunotherapy or 2 cycles of chemoimmunotherapy plus 2 cycles of immunotherapy, an ECOG performance status of 0 or 1, and adequate bone marrow and liver function were eligible for enrollment on the trial. Those with symptomatic brain metastases or an active, known, or suspected autoimmune disease were ineligible for study entry.

The academic trial was sponsored by Fondazione Ricerca Traslazionale (FoRT) and conducted at 19 sites in France, Italy, and Spain. Final results are scheduled to be presented at the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid, Spain.

What comes next for Tedopi in NSCLC?

Developers stated that the Combi-TED results support further evaluation of vaccine-based immunotherapy strategies in this setting. “A phase 3 registrational study of Tedopi monotherapy compared to docetaxel [ARTEMIA; NCT06472245]] is currently recruiting [patients with] NSCLC with secondary resistance to immunotherapy, with results expected in early 2028,” said Silvia Comis, MD, chief clinical and medical research officer at OSE Immunotherapeutics, in the news release.¹

OSE2101 is an investigational off-the-shelf therapeutic cancer vaccine that is restricted to patients who have HLA-A2–positive disease. The company plans to host a key opinion leader webcast on November 4, 2026, to discuss the results.

References

1. OSE Immunotherapeutics reports positive topline results of Combi-TED phase 2 randomized trial with Tedopi (OSE2101) in metastatic non-small cell lung cancer. News release. OSE Immunotherapeutics SA. October 19, 2026. Accessed October 20, 2026. https://tinyurl.com/y5k462j4
2. 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). ClinicalTrials.gov. Updated February 6, 2026. Accessed October 20, 2026. https://tinyurl.com/mtjapdpt