Rituximab Biosimilar Candidate Shows Clinical Equivalence in Non-Hodgkin Lymphoma

ABP 798, Amgen and Allergan’s biosimilar candidate to rituximab (Rituxan), demonstrated clinical equivalence compared with the reference product in patients with non-Hodgkin lymphoma, according to results from a comparative study.

Rituximab, an anti-CD20 monoclonal antibody, is currently approved for the treatment of adult patients with non-Hodgkin lymphoma, chronic lymphocytic leukemia, moderate-to-severe RA, pemphigus vulgaris, granulomatosis with polyangiitis and microscopic polyangiitis.

Non-Hodgkin lymphoma is one of the most common cancers in the United States and approximately 85% of cases originate in B cells, according to Amgen.

In the JASMINE study, the efficacy, safety, and immunogenicity of ABP 798 was compared with rituximab in patients with CD20-positive B-cell non-Hodgkin lymphoma. The study included 256 adults who were randomized to receive either ABP 798 or rituximab at a dose of 375 mg/m² administered as an intravenous (IV) infusion once weekly for 4 weeks followed by dosing at weeks 12 and 20.

According to the results, the primary endpoint, an assessment of overall response rate by week 28, was within the prespecified margin for ABP 798 compared with rituximab. Additionally, safety and immunogenicity of ABP 798 were comparable with rituximab.

“Today’s results with ABP 798 demonstrate another positive development from Amgen’s robust pipeline of biosimilar medicines and we look forward to working with regulatory agencies to bring this treatment to patients,” David M. Reese, MD, executive vice president of Research and Development at Amgen, said in a statement. “We continue to leverage our deep expertise and heritage in biologics across innovative and biosimilar medicines as part of our commitment to providing a range of treatment options for patients with the most serious diseases, including cancer.”

A previous study, which was conducted in patients with moderate-to-severe rheumatoid arthritis (RA), met the primary endpoint of pharmacokinetic similarity. In the RA study, the results also showed that ABP 798 and rituximab have pharmacokinetic similarity, equivalent efficacy, and a comparable safety profile for patients with the disease. The study included 311 patients with moderate-to-severe RA who received ABP 798 or rituximab via IV infusion at baseline and at week 24.

Reference

Amgen and Allergan Announce Positive Top-Line Results From Comparative Clinical Study of ABP 798, Biosimilar Candidate to Rituxan (Rituximab) [news release]. Amgen. https://www.amgen.com/media/news-releases/2019/08/amgen-and-allergan-announce-positive-topline-results-from-comparative-clinical-study-of-abp-798-biosimilar-candidate-to-rituxan-rituximab/. Accessed August 22, 2019.