Celltrion Publishes Global Phase 3 Results of Vegzelma in International Journal

[Financial News] Celltrion's Avastin (ingredient name Bevacizumab) biosimilar 'Vegzelma' showed excellent research results in global Phase 3 clinical trials.
Celltrion announced on the 31st that it has published the long-term results of the global Phase 3 clinical trial of Vegzelma (development name CT-P16) in the specialized journal of cancer treatment and research, 'Cancer Treatment and Research Communications'.
This study, which tracked patients participating in the CT-P16 global Phase 3 trial for three years, is a long-term follow-up clinical trial that comprehensively evaluated efficacy, safety, immunogenicity, and pharmacokinetics.
This clinical trial was conducted on 689 patients with metastatic non-small cell lung cancer (NSCLC), involving various races including Caucasians, Asians, Blacks, Native Americans, and Latin American mixed-race individuals.
Patients were randomly assigned to receive either Vegzelma or the original drug in a 1:1 ratio, and both groups underwent induction therapy including combination chemotherapy up to six times at three-week intervals.
Subsequently, treatment continued with either Vegzelma or the original drug alone, and efficacy and safety were evaluated up to three years after the last patient enrollment.
The results announced this time are an analysis of long-term data over three years after the last patient enrollment, with the objective response rate (ORR) during the entire clinical period disclosed for the first time. Additionally, similar results to the original drug were confirmed in major efficacy indicators such as duration of response (DoR), progression-free survival (PFS), and overall survival (OS).
In the long-term safety evaluation, Vegzelma showed a similar level of safety to the existing drug, with no newly reported serious drug-related adverse reactions throughout the entire period.
The comprehensive follow-up observation of major indicators considered during long-term treatment, such as immunogenicity, pharmacokinetics, and quality of life (QoL), over three years secured long-term data that can support the possibility of continuous treatment in real-world settings.
A Celltrion representative stated, "This clinical trial comprehensively proves the long-term treatment efficacy and safety of Vegzelma, providing meaningful data that can be used as a basis for prescription and an important achievement," adding, "As we have secured efficacy and equivalence compared to the original drug in major indicators such as objective response rate, survival rate, and quality of life, we will accelerate efforts to expand market share in major global countries."
Meanwhile, Vegzelma is currently being actively sold in major markets such as the United States and Europe. In Europe, it has already overtaken all competing products including the original to rank first in Bevacizumab prescriptions, solidifying its position.
In the United States, it achieved sales of approximately 75.8 billion won within a year of launch and continues to show visible results, recording a Medicare market share of over 6%.

vrdw88@fnnews.com Kang Jung-mo Reporter