Celltrion announced in a regulatory filing on the 14th that it has early terminated and voluntarily withdrawn the trial plan for the European Phase 3 clinical trial of 'CT-P51,' a biosimilar of the anticancer drug Keytruda (ingredient name: pembrolizumab).

This decision comes in response to recent changes in the global regulatory environment regarding biosimilar clinical trials. Celltrion revised its clinical and approval strategy in the direction of reducing the number of clinical trial subjects. Patient recruitment for the global Phase 3 clinical trial has already been fully completed. In particular, the company explained that with European Union (EU) countries excluded from the participating countries, there was no longer a need to maintain the European trial plan.

CT-P51 is a global Phase 3 clinical trial comparing the efficacy and safety against the original drug Keytruda in patients with previously untreated metastatic non-squamous non-small cell lung cancer.

The trial plan was submitted to the European Medicines Agency (EMA) on August 22, 2024 (local time) and approved on December 12 of the same year. According to the trial plan, the early termination date is specified as July 14, 2026 (local time).

Going forward, Celltrion plans to compare the efficacy and safety of CT-P51 and Keytruda through the ongoing global Phase 3 clinical trial in participating countries outside the EU. Regarding this filing, the company added that the date on which the notification of early trial termination was registered in CTIS (Clinical Trials Information System) is the 'date of fact confirmation.'