The European Phase III trial results for Celltrion’s follicular lymphoma drug have shown a near 100 percent tumor response rate, the Korean company said at the International Lymphoma Society in Lugano, Switzerland, Wednesday.

Truxima (compound: Rituximab) is Celltrion’s second antibody biosimilar product for the European market following Remsima as well as the world’s first anticancer antibody biosimilar approved by the European Medicines Agency, the company said.

In the clinical study, researchers compared the efficacy and safety of the drug with the original in patients with follicular lymphoma, a type of hematologic cancer.

Researchers divided 140 patients with the disease into two groups and administered either Truxima or the parent drug eight times at three-week intervals per Rituximab Combination Therapy (R-CVP) procedures.

As a result, the Truxima group proved a 97 percent tumor response rate, while the original group showed a 92.6 percent response rate, demonstrating non-inferiority of the drug to the original drug.

The study also confirmed equivalence in pharmacokinetics, pharmacokinetics, immunogenicity, and safety of Truxima and the parent drug.

“We proved non-inferiority of Truxima in follicular lymphoma in comparison to the original drug through this clinical trial,” said Professor Bertrand Coiffier of the University of Claude Bernard, a leading authority on blood cancer research. “We expect patients with the blood cancer to benefit from Truxima treatment.”

A Celltrion official also said, “Our company plans to conduct Truxima clinical trials for all indications of the original drug following the completion of clinical trials for patients with rheumatoid arthritis and follicular lymphoma. We will become a first-mover in the rituximab biosimilars market by accumulating prescription data and increasing confidence in our drug."

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