Positive phase III results for rituximab biosimilar CT-P10

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Positive phase III results for rituximab biosimilar CT-P10

Biosimilares/Investigación | Posted 25/01/2019 0 Post your comment

Celltrion has presented positive phase III results for its rituximab biosimilar CT‑P10 at the American Society of Hematology Meeting (ASH) annual meeting.

South Korean biotechnology company Celltrion announced on 4 December 2018 that it had presented positive phase III data for its rituximab biosimilar, CT‑P10 [1]. Celltrion says the data ‘shows that the efficacy and safety of CT‑P10 is comparable to reference rituximab in patients with advanced follicular lymphoma (AFL) over two years’.

Celltrion’s phase III (NCT02162771) trial is a randomized, parallel-group, active-controlled, double-blind, multicentre, international study in patients with previously untreated AFL when treated with rituximab plus cyclophosphamide, vincristine and prednisone (R-CVP) as an induction therapy. The study was designed to demonstrate the equivalence of pharmacokinetics and non-inferiority of efficacy for CT‑P10 in comparison with originator rituximab, Roche’s Rituxan (RTX). The study is expected to be completed in June 2020.

A total of 140 patients were randomized in a 1:1 ratio and 124 patients completed 8 cycles of R-CVP induction therapy. One hundred and twenty-two patients (62 CT‑P10 and 60 RTX), who showed response during the Induction Period, entered the Maintenance Period where a total of 12 cycles of rituximab monotherapy was to be administered every two months. The study was planned to continue until death or up to three years from the randomized date of the last patient.

The results showed similar overall survival (OS) (2-year OS: 93.2% CT‑P10 vs 95.3% RTX), progression-free survival (PFS) (2-year PFS: 75.2% CT‑P10 vs 73.5% RTX) and sustained response (overall response: 19.4% (13/67) CT‑P10 vs 21.3% (13/61) RTX) for CT‑P10 compared to the originator rituximab.

The results were presented at the 2018 American Society of Hematology (ASH) Annual Meeting, which took place on 1‒5 December 2018 in San Diego, California, USA.

Mr HoUng Kim, Head of Strategy and Operations Division, Celltrion Healthcare, said that ‘the two-year study marks another significant milestone for Celltrion Healthcare, showing that CT‑P10 is comparable to reference rituximab in terms of overall survival and progression-free survival’.

Celltrion received approval for Truxima (CT‑P10) in Europe in February 2017 [2] and in the US in November 2018 [3].

Biosimilars of rituximab

References
1. Kim W-S, Buske C, Kwak LW, et al. Similar efficacy and safety of CT-P10 and reference rituximab in patients with advanced stage follicular lymphoma: updated phase III study results. American Society of Hematology (ASH) Annual Meeting 2018; 1-5 December 2018; San Diego, California, USA. Abstract 1616.
2. GaBI Online - Generics and Biosimilars Initiative. EC approval for first cancer biosimilar Truxima [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jan 25]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-first-cancer-biosimilar-Truxima
3. GaBI Online - Generics and Biosimilars Initiative. FDA approves first rituximab biosimilar Truxima [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jan 25]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-first-rituximab-biosimilar-Truxima

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