[Hinews] Celltrion has published three-year clinical trial results for its Avastin biosimilar, Vegzelma (CT-P16), in the international oncology journal Cancer Treatment and Research Communications.

The study presents long-term follow-up data from a global phase 3 trial evaluating the efficacy, safety, immunogenicity, and pharmacokinetics of Vegzelma in 689 patients with metastatic non-small cell lung cancer.

Patients were randomized in a 1:1 ratio to receive either Vegzelma or the reference product Avastin, beginning with induction therapy every three weeks followed by maintenance monotherapy, with outcomes monitored over a three-year period. The study demonstrated clinical equivalence across key efficacy endpoints, including objective response rate (ORR), duration of response (DoR), progression-free survival (PFS), and overall survival (OS).

Long-term safety analysis confirmed that Vegzelma maintained a safety profile comparable to the originator, with no new serious adverse events reported. Measures of immunogenicity, pharmacokinetics, and quality of life (QoL) also remained stable throughout the three-year period, supporting the feasibility of long-term use.

Celltrion corporate identity, highlighting its biosimilar portfolio, including Vegzelma. (Image courtesy of Celltrion.)
Celltrion corporate identity, highlighting its biosimilar portfolio, including Vegzelma. (Image courtesy of Celltrion.)

A Celltrion spokesperson commented, “This study marks a major milestone in validating the long-term efficacy and safety of Vegzelma,” adding that the company plans to expand its presence in key global markets.

Vegzelma has achieved strong sales in major markets such as the United States and Europe, where it now leads in bevacizumab prescriptions. In the U.S., Vegzelma generated approximately 75.8 billion won (about $58 million USD) in revenue during its first year, capturing over 6% of the Medicare market share.

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