Combi-TED Phase 2 Clinical Trial Overview
OSE Immunotherapeutics and the FoRT Foundation have successfully announced the completion of patient enrollment in the Combi-TED study. This Phase 2 clinical trial evaluates the efficacy of Tedopi® combined with nivolumab or docetaxel, specifically aimed at treating patients with metastatic Non-Small Cell Lung Cancer (NSCLC).
Enrollment Details and Patient Demographics
A total of 105 patients, all HLA-A2 positive, have been enrolled in this innovative study. The research focuses on those eligible for second-line treatment after previous chemotherapy with an intention to optimize outcomes using this combination therapy. The anticipation surrounding the study is growing, with top-line results expected to be revealed in the latter part of 2026.
The Significance of the Tedopi® Treatment
Tedopi® is a therapeutic vaccine targeting neoepitopes that can activate the immune system to combat cancer. This approach is distinct as it aims to amplify the effects of existing treatments, such as the PD-1 checkpoint inhibitor or chemotherapy, in patients who previously underwent first-line chemo-immunotherapy. This innovative treatment strategy represents a significant advancement in the way metastatic NSCLC could be approached.
Study Design and Objectives
The Combi-TED trial is designed as an open-label, randomized, three-arm study. It compares the effects of Tedopi® in conjunction with nivolumab or docetaxel against docetaxel alone. The primary endpoint of the trial is determining the one-year survival rate among participants, making this an important benchmark for evaluating the treatment’s effectiveness.
Expert Insights on the Trial
Dr. Federico Cappuzzo, the Chief Investigator and Director of Medical Oncology at the Cancer Institute Regina Elena in Italy, expressed enthusiasm about reaching this crucial milestone in patient enrollment. He noted that the potential for Tedopi® to enhance existing treatments could transform the landscape of options available to NSCLC patients who have already undergone significant therapies.
Future Directions and Expectations
As the Combi-TED trial progresses, the team at OSE Immunotherapeutics remains hopeful for breakthrough findings that may adjust future cancer treatment protocols. The combined insights from this study and the ongoing ARTEMIA trial, which evaluates Tedopi® as a standalone treatment in different populations, will contribute significantly to the understanding of effective treatment strategies for those battling NSCLC.
About OSE Immunotherapeutics
OSE Immunotherapeutics is a forward-thinking biotechnology company dedicated to developing pioneering treatments in immuno-oncology and immuno-inflammation. The company collaborates closely with various academic institutions and biopharmaceutical companies to deliver revolutionary therapies for critical unmet medical needs. Based in Nantes and Paris, OSE Immunotherapeutics is publicly traded on the Euronext exchange.
Contacts
Fiona Olivier
fiona.olivier@ose-immuno.com
Sylvie Détry
sylvie.detry@ose-immuno.com
French Media Contact:
Florence Portejoie, FP2COM
fportejoie@fp2com.fr
+33 6 07 768 283
U.S. Media Contact:
Kate Barrette, Rooney Partners LLC
kbarrette@rooneypartners.com
+1 212 223 0561
Frequently Asked Questions
What is the Combi-TED clinical trial?
The Combi-TED trial is a Phase 2 clinical study evaluating the therapeutic vaccine Tedopi® combined with either nivolumab or docetaxel in NSCLC patients.
Who is overseeing the study?
The trial is sponsored and conducted by OSE Immunotherapeutics in collaboration with the FoRT Foundation.
How many patients are enrolled in the study?
105 HLA-A2 positive patients are enrolled in the Combi-TED trial.
What is the expected outcome of the trial?
The primary endpoint is to determine the one-year survival rate for patients receiving the treatments.
When can we expect results from the trial?
Top-line results from the study are anticipated to be available in late 2026.
