The following article features coverage from the American Society of Hematology (ASH) 2018 meeting. Click here to read more of Cancer Therapy Advisor‘s conference coverage.

CT-P10, a biosimilar to rituximab, was therapeutically equivalent to rituximab as a monotherapy in a phase 3 trial of patients with untreated low tumor burden follicular lymphoma, according to data presented at the 60th American Society of Hematology (ASH) Annual Meeting in San Diego, California.1

After 7 months of treatment, patients assigned to CT-P10 had an overall response rate of 83.1% compared with 81.3% for patients assigned to rituximab (difference of 1.8%; 90% CI, –6.43 to 10.20).

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The biosimilar was approved by the US Food and Drug Administration for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin lymphoma as a single agent or in combination with chemotherapy. It is the first biosimilar approved by the FDA for treatment of non-Hodgkin lymphoma. CT-P10 had previously shown non-inferior efficacy in follicular lymphoma when given in combination with cyclophosphamide, vincristine, and prednisone.

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In the study, researchers led by Michinori Ogura, MD, PhD, of Kasugai Municipal Hospital, Konan, Japan, randomly assigned 258 patients to CT-P10 or rituximab; 231 patients completed treatment to 7 months. All patients had stage II to IV follicular lymphoma with low tumor burden. Monotherapy was given for 4 weeks as induction therapy, followed by maintenance every 2 months for 2 years.

The two drugs had similar pharmacokinetic profiles with similar trough concentration at each cycle.

Overall, the biosimilar CT-P10 was well tolerated with a safety profile consistent with that reported for rituximab. The majority of patients assigned both drugs experienced treatment-emergent adverse events.

Adverse events of special interest were similar between treatment arms and included infections and infusion-related reactions. No progressive multifocal leukoencephalopathy or hepatitis B was reported in either group.

Read more of Cancer Therapy Advisor‘s coverage of the ASH 2018 meeting by visiting the conference page.


  1. Ogura M Sancho JM, Cho SG, et al. Comparison of efficacy and safety of biosimilar CT-P10 to rituximab in patients with previously untreated low tumor burden follicular lymphoma (LTBFL): a randomized phase III study. Poster presentation at: American Society of Hematology 60th Annual Meeting & Exposition; December 1-4, 2018; San Diego, CA. Abstract 1596.