The study’s authors concluded that, at the median follow-up of 23 months, the data demonstrated comparable progression-free survival, sustained response, and overall survival between both the biosimilar and the reference product.
At the American Society of Hematology’s annual meeting in San Diego, California, that took place December 1-4, 2018, researchers presented data from an ongoing randomized, double-blind trial that compared the efficacy of CT-P10 (Truxima)—a newly FDA-approved rituximab biosimilar—with reference rituximab (Rituxan) in patients with previously untreated advanced follicular lymphoma.
The study enrolled 140 patients, 124 patients of whom completed the full 8 cycles of rituximab, cyclophosphamide, vincristine, prednisone (R-CVP) induction therapy. In total, 122 patients who showed response during the induction period (62 patients in the CT-P10 treatment arm and 60 patients in the reference arm) then moved on to the maintenance period, during which 12 cycles of rituximab monotherapy were administered at intervals of 2 months.
Efficacy was determined based on outcomes including progression free survival, duration of response, and overall survival (OS). The updated safety profile of CT-P10 compared with reference rituximab in advanced follicular lymphoma was also assessed. The study was designed to continue until death or up to 3 years from the randomized date of the last patient.
At the time of the cutoff date, the median follow-up was 23 months (range, 0.5-34) in the CT-P10 group and 22 months (range, 0.2-33) in the reference rituximab group. The rates of relapse, disease progression, or death from any cause were 22.9% and 24.3% for the CT-P10 and reference rituximab groups, respectively.
As for sustained response, the proportion of patients who showed relapse or disease progression after previously achieving overall response was 19.4% in CT-P10 arm and 21.3% in the reference arm. Notably, there was no statistically significant difference in OS between either group with a 2-year OS of 93.2% for CT-P10 patients and 95.3% in reference rituximab patients.
Furthermore, “The updated safety results did not reveal any new trends or new signals noted in the patients treated with CT-P10,” a Celltrion representative told The Center for Biosimilars® in an email.
The study’s authors concluded that, at the median follow-up of 23 months, the data demonstrated comparable progression-free survival, sustained response, and OS between both the biosimilar and the reference product.
CT-P10 was approved by the FDA on November 28, 2018, under the brand name Truxima, though a launch date has yet to be disclosed. “Celltrion and Teva Pharmaceutical Industries entered into an exclusive partnership in October 2016 to commercialize Truxima in the US and Canada. Teva and Celltrion have reached a settlement agreement with Genentech, including entry terms. The terms and conditions of that agreement are confidential at this time,” noted Woosung Kee, CEO of Celltrion.
Won-Seog, K, Buske C, Kwak L, et al.Similar efficacy and safety of CT-P10 and reference rituximab in patients with advanced stage follicular lymphoma: updated phase III study results. Presented at the 60th Annual Meeting and Exposition of the American Society of Hematology; December 1-4, 2018; San Diego, California. Abstract 1616. ash.confex.com/ash/2018/webprogram/Paper112716.html.