Celltrion Confirms Efficacy and Safety of Vegzelma in Three-Year Long-Term Clinical Study

CT-P16 Demonstrates Similarity to Original in Response Rate and Progression-Free Survival
Meaningful Results Also Observed in Safety, Immunogenicity, and Quality of Life Indicators

Celltrion announced on July 31 that the results of a long-term global Phase 3 clinical study of Vegzelma (CT-P16), a biosimilar of Avastin (active ingredient: bevacizumab), have been published in the international journal "Cancer Treatment & Research Communications," which specializes in cancer treatment and research.

This long-term follow-up clinical study tracked patients who participated in the global Phase 3 trial of CT-P16 for three years, comprehensively evaluating efficacy, safety, immunogenicity, and pharmacokinetics. The global clinical trial was conducted on 689 patients with metastatic non-small cell lung cancer (NSCLC), and included a diverse range of ethnicities such as Caucasians, Asians, Black people, Native Americans, and people of mixed Latin American descent.

Patients were randomly assigned in a 1:1 ratio to receive either Vegzelma or the reference medicine. Both groups received induction therapy, including combination chemotherapy, at three-week intervals for up to six cycles. Afterward, treatment continued with monotherapy of either Vegzelma or the reference medicine. Efficacy and safety were evaluated up to three years after the last patient was enrolled.

The results announced this time are based on an analysis of long-term data over three years following the last patient enrollment, and for the first time, the objective response rate (ORR) for the entire clinical period has been disclosed. In addition, key efficacy indicators such as duration of response (DoR), progression-free survival (PFS), and overall survival (OS) showed similar results to the reference medicine.

In the long-term safety assessment, Vegzelma demonstrated a safety profile comparable to that of the reference product, with no newly reported serious drug-related adverse events throughout the entire period. Furthermore, long-term monitoring over three years of key indicators relevant to extended treatment?such as immunogenicity, pharmacokinetics, and quality of life (QoL)?provided comprehensive data supporting the potential for sustained treatment in real-world clinical settings.

A Celltrion representative stated, "This clinical study comprehensively demonstrates the long-term therapeutic effect and safety of Vegzelma, providing meaningful data that can serve as a basis for prescription decisions and representing a significant achievement. Since Vegzelma has secured efficacy and equivalence to the reference medicine in key indicators such as objective response rate, survival rate, and quality of life, we will accelerate efforts to expand our market share in major global markets."

Vegzelma is currently being actively sold in major markets such as the United States and Europe. In Europe, it has solidified its position by surpassing all competitors, including the original product, to become the number one prescribed bevacizumab. In the United States, it achieved sales of approximately 75.8 billion KRW within one year of launch and has attained a Medicare market share of over 6%, continuing to deliver visible results.

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