Rituximab Biosimilar Demonstrates Comparable Safety, Efficacy to Reference Drug

New data from a phase 3 study shows that CT-P10 (Truxima), a biosimilar of rituximab, is comparable in safety and efficacy to the reference product’s oncology and autoimmune disease indications.

CT-P10 is a monoclonal antibody designed to target CD20 proteins, which are located on the surface of most B cells,

The double-blind, randomized, controlled phase 3 study included 140 treatment-naïve patients with advanced follicular lymphoma (FL), according to the press release.

The results of the study showed that CT-P10 was non-inferior in terms of efficacy compared with the reference rituximab when each were administered in combination with cyclophosphamide, vincristine, and prednisone for 8 cycles.

Additionally, results demonstrated that CT-P10’s safety profile, pharmacokinetics, pharmacodynamics, and immunogenicity were comparable to those of reference rituximab.

“The data presented add to the increasing wealth of evidence for biosimilar rituximab and demonstrate that CT-P10 was non-inferior in terms of efficacy and comparable in pharmacokinetics and safety to the reference to rituximab for patients with advanced stage follicular lymphoma,” Bertrand Coiffier, head of the Department of Hematology, Hospices Civils de Lyon in France, said in a release. “Switching to biosimilar rituximab presents opportunities for health care systems across the world to reduce the costs associated with oncology treatments, paving the way for greater patient access for new innovative medicines.”

In patients with rheumatoid arthritis, comparable long-term safety and efficacy were observed between CT-P10 and reference rituximab when treated over 48 weeks.

There were no clinically meaningful differences observed between the groups who took part in the randomized 372-patient study, according to the release.

“Our studies consistently demonstrate the equivalence and comparability of our biosimilar rituximab, CT-P10, to reference rituximab,” Dr Kwon Hyuk-chan, medical director of Celltrion Healthcare, said in a release. “We are the only company that is able to proudly state that we have conducted phase 3 clinical trials looking into the safety and efficacy of its biosimilar in 2 indications—–rheumatoid arthritis and non-Hodgkin’s lymphoma––which is a testament to our commitment to providing quality biosimilar treatments for patients supported by robust clinical data.”

Using data from the phase 3 trial, investigators conducted a post-hoc analysis that examined the impact of body mass index (BMI) on clinical response. They found that the clinical response to both the biosimilar and reference product is unaffected by BMI over 48 weeks, contrasting data indicating a known association between high BMI and inadequate clinical response to anti-tumor necrosis factor (TNF) agents.

This suggests that rituximab is an effective treatment option for obese patients with RA who have an inadequate response to anti-TNF agents.

“The data in support of CT-P10 are very encouraging, as it means that biosimilar rituximab could prove a reasonable therapeutic alternative to patients with rheumatoid arthritis who have a high BMI and have had an inadequate response to anti-TNFs,” Dr Dae-Hyun Yoo, global principal investigators of the RA study, said in a release.

The findings were presented at the International Conference on Malignant Lymphoma (ICML) and the European League Against Rheumatism (EULAR) congress 2017.