Celltrion conducted a clinical three-phase long-term tracking of Advanced Follicular Lymphoma (AFL) patients, a type of blood cancer, at the 2019 American Society of Hematology (ASH 2019) in Orlando, Florida, U.S. from Dec. 7 (local time).
And it has found that Truxima, an antibody biosimilar for blood cancer treatment, has similar effects and safety effects to the original drug Rituximab.
The study was conducted on 140 AFL patients with Truxima and Rituxan, respectively, and the results of the 40-month central monitoring showed that Truxima's overall survival rate (OS), Progress-Free Survival (PFS), and the time to time progressive (TTP) for tumor duration were similar to those of original medicines.
Clinical results show that estimates of the four-year overall survival rate (OS) of patients treated for Truxima and Rituxan were 88.0%, 93.3%, PFS, which means the probability of a patient surviving without progress or death of a tumor, 60.9%, 54.7%, and TTP, which refers to the duration of tumor progress from random assignment, 64.2% and 69%, respectively.
Statistical verification has confirmed that the efficacy and safety of Truxima are similar to the original drug throughout the entire clinical period.
Christian Buske, a professor of blood tumor medicine at Germany's Comprehensive Cancer Center Ulm University Hospital, said, "This is meaningful for the first time in announcing the long-term clinical results of the Rituximab biosimilar," adding that it is expected that future treatments will be more likely to be prescribed by Truxima as its similarity in long-term effectiveness and safety was proved.