Study Demonstrates Therapeutic Equivalence Between Biosimilar CT-P10 and Rituximab in Patients with Follicular Lymphoma

CT-P10 (Truxima™, Celltrion Healthcare) is the first biosimilar of the reference monoclonal anti-CD20 antibody rituximab and has similar properties. At the ASH annual meeting, researchers presented results of an ongoing, phase III, randomized, double-blind, controlled trial that is comparing efficacy and safety between CT-P10 and rituximab as monotherapy in patients with newly diagnosed follicular lymphoma (FL) with low tumor burden (LTB). They found that both agents were therapeutically equivalent and well-tolerated, with similar safety profiles, over seven months.

The study randomized 258 patients with FL-LTB to receive CT-P10 or rituximab (375 mg/m2 intravenously) as monotherapy weekly for four weeks as induction therapy, followed by maintenance therapy every two months for two years. To be eligible for maintenance therapy, patients had to achieve complete response, unconfirmed complete response, partial response, or stable disease after induction therapy. Subsequently, 231 patients completed up to seven months of treatment—119/130 (92%) of those receiving CT-P10 and 112/128 (88%) receiving rituximab.

The primary endpoint for this portion of the trial was overall response rate (ORR) over seven months. ORRs of 83.1% and 81.3% for CT-P10 and rituximab, respectively, were observed, according to lead author Michinori Ogura, MD, PhD, of Kasugai Municipal Hospital in Konan, Japan, and an international team of colleagues from Japan, Spain, South Korea, Russian, the United Kingdom, Portugal, Poland, Belarus, Chile, the Czech Republic, France, and Germany, and the United States. The authors also presented data indicating similar pharmacokinetics between the two agents.

Furthermore, the authors reported that CT-P10 was well tolerated. Both agents had a similar safety profile, and the researchers observed no new findings. Adverse event rates were 71% with CT-P10 and 67% with rituximab. Infections and infusion-related reactions occurred in a similar proportion of patients in both groups, and no patients experienced progressive multifocal leukoencephalopathy or hepatitis B virus reactivation.

Of note, on November 28, 2018, the U.S. Food and Drug Administration approved CT-P10 as the first biosimilar to rituximab for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL) to be used as a single agent or in combination with chemotherapy. In February 2017, the European Medicines Agency approved it for use in all indications for which rituximab is approved, including FL, diffuse large B-cell NHL, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis.