OSE Immunotherapeutics has announced that the Independent Data Monitoring Committee (IDMC) has issued a second positive recommendation for the ongoing pivotal Phase III ARTEMIA trial evaluating Tedopi in advanced non-small cell lung cancer (NSCLC).
The IDMC recommended that the study continue as planned, with no protocol changes.
As part of the established study oversight plan, the Independent Data Monitoring Committee (IDMC), comprising impartial clinical and statistical experts, conducted a thorough evaluation of patient safety, trial execution and key efficacy indicators.
Following this review, the IDMC recommended that the study proceed without any modifications, affirming that the trial has been conducted robustly to this point.
Dr Silvia Comis, Chief Clinical and Medical Research Officer at OSE Immunotherapeutics, said: "We welcome this new positive assessment from the IDMC."
A total of 163 patients had been randomised at the time of the meeting, with 152 included in the analysis reviewed by the IDMC. These figures are fully consistent with our recruitment objectives.
Initiated in 2024, the ARTEMIA trial is comparing Tedopi monotherapy with standard docetaxel in HLA-A2–positive patients with metastatic NSCLC who have developed secondary resistance to immune checkpoint inhibitors.
The trial is enrolling participants at sites across Europe, the UK, the US and Canada. It is designed to generate confirmatory data to support potential regulatory filings.
The next review by the Independent Data Monitoring Committee (IDMC) is scheduled for October 2026, with study enrollment expected to conclude by the end of 2026.
An interim futility analysis for Tedopi in the NSCLC pivotal Phase III trial is anticipated in the third quarter of 2026, with primary endpoint results for overall survival expected in the first quarter of 2028.