The research represents a comprehensive long-term follow-up from a global phase 3 trial assessing efficacy, safety, immunogenicity, and pharmacokinetics in 689 patients with metastatic non-small cell lung cancer.
Participants were randomized 1:1 to receive either Vegzelma or the reference product, undergoing induction therapy every three weeks followed by monotherapy with three years of monitoring. Equivalence between the two agents was demonstrated across primary endpoints, including objective response rate (ORR), duration of response (DoR), progression-free survival (PFS), and overall survival (OS).
Long-term safety evaluations showed Vegzelma maintaining a safety profile comparable to the originator, with no new serious adverse reactions emerging. Immunogenicity, pharmacokinetics, and quality of life (QoL) measures also remained stable over the three-year period, reinforcing the viability of extended therapy.
A Celltrion representative stated, “This study marks a significant milestone in validating Vegzelma’s long-term efficacy and safety,” and added, “We plan to ramp up market penetration in key global regions.”
Vegzelma is currently seeing strong sales in markets like the United States and Europe, where it has overtaken rivals to claim the top spot in bevacizumab prescriptions. In the U.S., the product generated approximately 75.8 billion won in revenue during its first year on the market, surpassing a 6% share in the Medicare segment.
Kim Kuk Ju, HEALTH IN NEWS TEAM
press@hinews.co.kr
