Celltrion Unveils Phase 3 Clinical Trial Results of 'CT-P16' for the First Time at the American Association for Cancer Research Meeting

Avastin Biosimilar... Efficacy Equivalence and Safety Confirmed
Marketing Authorization Applications Submitted in Korea, the US, and Europe

[Asia Economy Reporter Lee Gwan-joo] Celltrion announced on the 13th that it has unveiled the Phase 3 clinical trial results of the Avastin (active ingredient Bevacizumab) biosimilar 'CT-P16' for the first time at the American Association for Cancer Research (AACR).

AACR is one of the world's most prestigious cancer conferences and was held as an in-person event for the first time in three years from the 8th to the 13th of this month (local time) in New Orleans, USA.

Through this AACR poster presentation, Celltrion disclosed the Phase 3 clinical trial results conducted on 689 patients with non-small cell lung cancer, one of Avastin's main indications. The subjects were divided into two groups and administered either CT-P16 or Avastin in combination with chemotherapy once every three weeks for up to six cycles, followed by monotherapy for up to three years.

This presentation primarily focused on the efficacy evaluation results during the induction period, which was the primary endpoint of the clinical trial. CT-P16 satisfied the margin range for demonstrating equivalence in objective response rate (ORR) comparison with the original drug during the induction period after administration, thereby proving equivalence in efficacy with the original drug.

The original drug Avastin is a blockbuster anticancer agent developed by the multinational pharmaceutical company Roche and is used to treat non-small cell lung cancer, metastatic colorectal cancer, metastatic breast cancer, glioblastoma, and others. As of last year, it recorded global sales of approximately 4 trillion KRW.

Based on the global Phase 3 clinical trial results, Celltrion has completed the application for marketing authorization of CT-P16 for the full label indications approved for Avastin in Korea, the United States, Europe, and other regions. Once the approval processes in each country are completed, the product will be sequentially launched in the global market. With the launch of CT-P16, Celltrion will secure its third anticancer antibody biosimilar following the existing hematologic cancer treatment Truxima and breast cancer treatment Herzuma.

A Celltrion official stated, “CT-P16 has demonstrated efficacy equivalence and safety similarity compared to the original drug in a large-scale global Phase 3 clinical trial, and we plan to accelerate the approval process through consultations with regulatory authorities in each country. We will do our best to ensure the prompt supply of high-quality anticancer antibody biosimilars as soon as approvals are obtained.”

This content was produced with the assistance of AI translation services.