Celltrion unveils long-term P3 trial results for Truxima in US
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Press Release[/caption]
Celltrion said that it has presented the long-term follow-up results of its phase 3 clinical trial of Truxima in treating advanced follicular lymphoma (AFL) patients, at the American Society of Hematology (ASH) 2019 conference.
According to the company, it confirmed that Truxima showed similar efficacy and safety in treating AFL patients when compared to the original Rituxan.
The company treated 140 AFL patients with either Truxima or Rituxan, and the 40-month follow-up period showed similar overall survival (OS), progress-free survival (PFS), and time to progressive (TTP) in both drugs.
In detail, the trial results showed the OS estimates at four years for Truxima and Rituxan were 88 and 93.3 percent, respectively, while PFS was 60.9 and 54.7 percent, and TTP was 64.2 and 60.9 percent, respectively.
"Statistical validation confirmed that Truxima's efficacy and safety were similar to those of the original drug throughout the entire clinical period," a company official said. "This clinical trial was conducted for 40 months on patients in India, Japan, Russia and the EU, including Germany and Spain."
Based on these medical verifications, Truxima will significantly contribute to improving medical welfare and easing the financial burden of blood cancer patients worldwide, he added.
Professor Christian Buske at Germany's Comprehensive Cancer Center Ulm said, "The trial is meaningful as it is the first long-term clinical results for rituximab biosimilars. As the long-term efficacy and safety similarities between Truxima and the original drug have been demonstrated, prescriptions are expected to increase."
The company has launched Truxima in the United States through Teva, its North American distribution partner. Truxima is the first rituximab biosimilar in the U.S. market, which has an annual sale of about 5 trillion won ($4.2 billion).
Press Release[/caption]
Celltrion said that it has presented the long-term follow-up results of its phase 3 clinical trial of Truxima in treating advanced follicular lymphoma (AFL) patients, at the American Society of Hematology (ASH) 2019 conference.
According to the company, it confirmed that Truxima showed similar efficacy and safety in treating AFL patients when compared to the original Rituxan.
The company treated 140 AFL patients with either Truxima or Rituxan, and the 40-month follow-up period showed similar overall survival (OS), progress-free survival (PFS), and time to progressive (TTP) in both drugs.
In detail, the trial results showed the OS estimates at four years for Truxima and Rituxan were 88 and 93.3 percent, respectively, while PFS was 60.9 and 54.7 percent, and TTP was 64.2 and 60.9 percent, respectively.
"Statistical validation confirmed that Truxima's efficacy and safety were similar to those of the original drug throughout the entire clinical period," a company official said. "This clinical trial was conducted for 40 months on patients in India, Japan, Russia and the EU, including Germany and Spain."
Based on these medical verifications, Truxima will significantly contribute to improving medical welfare and easing the financial burden of blood cancer patients worldwide, he added.
Professor Christian Buske at Germany's Comprehensive Cancer Center Ulm said, "The trial is meaningful as it is the first long-term clinical results for rituximab biosimilars. As the long-term efficacy and safety similarities between Truxima and the original drug have been demonstrated, prescriptions are expected to increase."
The company has launched Truxima in the United States through Teva, its North American distribution partner. Truxima is the first rituximab biosimilar in the U.S. market, which has an annual sale of about 5 trillion won ($4.2 billion).
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