Celltrion (068270.KS) said Tuesday it has submitted an amendment to its global Phase 3 clinical trial plan for CT-P51, a Keytruda biosimilar for non-small cell lung cancer, to the U.S. Food and Drug Administration (FDA), the company said in a regulatory filing.
The clinical trial is being conducted in patients with previously untreated metastatic non-squamous non-small cell lung cancer. The trial aims to directly compare the efficacy and safety of the original drug Keytruda and CT-P51.
The trial will randomize a total of 220 subjects in a double-blind, active-controlled design. This represents a sharp reduction from the previous patient count of about 600 to roughly one-third. The overall treatment period for the trial is set at two years and will be carried out as a global Phase 3 clinical stage.
Celltrion disclosed the date of the board resolution and the fact confirmation date as Tuesday, the same day it submitted the amendment to its drug clinical trial plan to the U.S. FDA. The registration number is EU CT number 2024-514048-98-00.
Meanwhile, Celltrion cautioned that the probability of a trial drug ultimately receiving approval as a pharmaceutical product is statistically around 10%, and that commercialization plans may be changed or abandoned if results fall short of expectations.
"In the CT-P51 global Phase 3 trial, we are applying a more efficient clinical development strategy by reducing the number of patients from about 600 to around 220 through consultation with regulatory authorities," a Celltrion official said. "We will do our best to accelerate the ongoing clinical development, and after approval, to quickly enter major markets based on our own drug manufacturing and global sales capabilities."
