Home / Biosimilars / Research / Comparative results for CT-P10 in low-tumour burden FL

Comparative results for CT-P10 in low-tumour burden FL Posted 30/11/2018

According to research in patients with low-tumour burden follicular lymphoma (FL), the efficacy and pharmacokinetics of rituximab biosimilar CT‑P10 are equivalent or non-inferior to the originator rituximab, Roche’s MabThera/Rituxan [1].

The ongoing, randomized, double-blind, parallel-group, active-controlled, phase III trial enrolled 258 adult patients (≥18 years) with stage II–IV low-tumour-burden follicular lymphoma. The patients were randomly assigned (1:1) to CT‑P10 (130) or US-sourced rituximab (128).

A total of 108 (83%) of the 130 patients assigned to CT‑P10 and 104 (81%) of the 128 assigned to rituximab achieved an overall response by month 7 (treatment difference estimate 1·8%; 90% CI −6·43 to 10·20). Therapeutic equivalence was shown (90% CIs were within the prespecified margin of 17%). The most common grade 3 or 4 treatment-emergent adverse events were decreased neutrophil count (two grade 3 in the CT‑P10 group) and neutropenia (one in each group); all other grade 3 or 4 treatment-emergent adverse events occurred in one patient each. Six (5%) of the 130 patients who received CT‑P10 and three (2%) of the 128 who received rituximab experienced at least one treatment-emergent serious adverse event.

The authors therefore concluded that ‘CT‑P10 was equivalent to rituximab in terms of efficacy and was well tolerated’. They went on to suggest that CT‑P10 monotherapy could be ‘a new therapeutic option for patients with low-tumour-burden follicular lymphoma’.

These results are in line with previous results from CT‑P10 in patients with rheumatoid arthritis and advanced (stage III-IV) follicular lymphoma patients [2].

CT‑P10 was recommended for approval by FDA’s Oncologic Drugs Advisory Committee (ODAC) on 10 October 2018 [3]. Celltrion received approval from the Korean Ministry of Food and Drug Safety (MFDS) for its rituximab biosimilar in November 2016 [4]. The company received European Commission (EC) approval for Truxima (CT‑P10) in February 2017 [5]. Then Blitzima, Ritemvia and Rituzena (previously Tuxella) were also approved by the EC in July 2017 [6]. Celltrion also received approval for CT‑P10 from Australia’s Therapeutic Goods Administration (TGA) in April 2018 [7].

Conflict of interest
The authors of the research paper [1] declared that the research was funded by Celltrion.

Related articles
Biosimilars approved in the US

Biosimilars of rituximab

References
1. Ogura M, Sancho JM, Cho S-G, et al. Efficacy, pharmacokinetics, and safety of the biosimilar CT-P10 in comparison with rituximab in patients with previously untreated low-tumour-burden follicular lymphoma: a randomised, double-blind, parallel-group, phase 3 trial. Lancet 2018;5(11):PE543-E553
2. GaBI Online - Generics and Biosimilars Initiative. Positive phase III results for Celltrion’s rituximab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 30]. Available from: www.gabionline.net/Biosimilars/Research/Positive-phase-III-results-for-Celltrion-s-rituximab-biosimilar
3. GaBI Online - Generics and Biosimilars Initiative. FDA advisers recommend approval of rituximab biosimilar CT-P10 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 30]. Available from: www.gabionline.net/Biosimilars/News/FDA-advisers-recommend-approval-of-rituximab-biosimilar-CT-P10
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilar rituximab approved in South Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 30]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-rituximab-approved-in-South-Korea
5. GaBI Online - Generics and Biosimilars Initiative. EC approval for first cancer biosimilar Truxima [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 30]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-first-cancer-biosimilar-Truxima
6. GaBI Online - Generics and Biosimilars Initiative. EC approval for three rituximab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 30]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-three-rituximab-biosimilars
7. GaBI Online - Generics and Biosimilars Initiative. Australia approves rituximab biosimilar Truxima [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 30]. Available from: www.gabionline.net/Biosimilars/News/Australia-approves-rituximab-biosimilar-Truxima

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2018 Pro Pharma Communications International. All Rights Reserved.

Comments (0)

Generics News Research General

more

Biosimilars News Research General

more