OSE Immunotherapeutics has announced that the Independent Data Monitoring Committee (IDMC) overseeing the Company’s international Phase III clinical trial, ARTEMIA, has issued a positive recommendation to continue the study without modifications.
The trial is evaluating Tedopi in non-small cell lung cancer (NSCLC).
As outlined in the study protocol of ARTEMIA, the IDMC meets on a regular basis to review data from the ongoing trial.
The IDMC is a group of independent experts, including one US and one European lung cancer expert and an independent statistician who are external to the study.
Their role is to assess the progress, safety data and critical efficacy endpoints of the clinical trial for safeguarding the interests of study participants.
The IDMC provides the sponsor and the Steering committee with recommendations regarding study modification, continuation or termination.
IDMCs are customary for large, randomised, multi-site studies, such as ARTEMIA.
Dr Silvia Comis, Chief Clinical and Medical Research Officer at OSE Immunotherapeutic, said: “We are very pleased with the IDMC’s recommendation to continue our Phase III trial without changes."
"As of early October, date of the IDMC meeting, 102 patients had been randomised in the trial."
"We are now approaching 120, fully aligned with our enrollment projections for 2025.”
The ARTEMIA trial was launched in September 2024 and is designed to compare Tedopi monotherapy to standard-of-care docetaxel in HLA-A2-positive patients with metastatic NSCLC who have developed secondary resistance to immune checkpoint inhibitors.
The study is being conducted across multiple international sites in Europe, the UK, the US and Canada and aims to provide confirmatory data to support regulatory submission.
A second IDMC review is anticipated in Q1 2026.
Completion of recruitment in the ARTEMIA trial is foreseen for the end of 2026, with readout for the primary endpoint of overall survival in Q1 2028.