Proposed Biosimilar to Ocrelizumab Shows Comparability With Reference Product

Key Takeaways

Xacrel, a biosimilar to Ocrevus, showed comparable efficacy and safety in treating relapsing-remitting MS, with no significant differences in annualized relapse rate.
The study included 85 patients, aged 18 to 55, with relapsing-remitting MS, assessing outcomes over 96 weeks, including relapse rates and disability progression.
Both biosimilar and reference groups had similar safety profiles, with most patients experiencing at least one adverse event, supporting Xacrel's potential as an alternative treatment.

Ocrelizumab (Ocrevus; Genentech) is used for the management and treatment of multiple sclerosis.

Proposed biosimilar ocrelizumab (Xacrel; Cinnagen) showed comparability for efficacy, safety, and immunogenicity compared with ocrelizumab (Ocrevus; Genentech). Ocrelizumab is used for the management and treatment of multiple sclerosis (MS). It is a second-generation anti-CD20 recombinant monoclonal antibody, which is expected to reduce antigenicity and improve CD20 binding.^1,2

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MS causes the breakdown of protective nerve coverings called myelin, which can cause neurological symptoms such as numbness, weakness, trouble walking, and vision changes. The disease can cause permanent damage to the nerve fibers and can be categorized as relapsing-remitting MS, secondary-progressive MS, primary-progressive MS, clinically isolated syndrome, and radiologically isolated syndrome. Women are 2 to 3 times more likely to have MS, according to Mayo Clinic.³

In the study (NCT04966338), investigators aimed to evaluate the efficacy and safety of the biosimilar with the reference product for individuals with relapsing remitting multiple sclerosis. Individuals were given either the biosimilar ocrelizumab or the reference ocrelizumab 600 mg, as dual infusions of 200 mg on day 1 and 15 for the first 24-week treatment cycle and as a single infusion of 600 mg on day 1 for each 24-week cycle after.⁴

Investigators included individuals aged 18 to 55 years who were diagnosed with MS and had at least 2 relapses within the past 2 years or 1 relapse within the past 12 months prior to screening. The primary end point was annualized relapse rate at 48 weeks, and secondary outcomes included time to onset of sustained disability progression up to week 96, proportion of relapse-free patients by 96 weeks, total number of new Gadolinium-enhancing lesions up to week 96, total number of new, and/or enlarging T2 hyperintense lesions up to week 96, change in total T2 lesion volume up to week 96, number of individuals with adverse events (AEs), and number of individuals with infusion-related AEs. There was also an immunogenicity assessment.⁴

About The Trial

Trial Name: Efficacy and Safety of Xacrel (Ocrelizumab) in Participants With Relapsing Remitting Multiple Sclerosis

ClinicalTrials.gov ID: NCT04966338

Sponsor: Cinnagen

Completion Date: October 2021

There were 85 patients included in the study who received either the biosimilar or the reference product. The ARR at 48 weeks was 0.067 in the biosimilar group compared with 0.070 in the reference product group, with no significant differences between the 2. The primary endpoint was met, according to the study authors. Furthermore, the rate of 12-week disability progression was 7.06% in the biosimilar group compared with 5.9% in the reference product group. At week 24, the percentage was 7.06% and 2.35%, respectively.¹

Investigators reported that 89.41% of patients in the biosimilar group and 87.10% in the reference product group were relapse-free at 96 weeks. For the safety outcomes, 97.65% experienced at least 1 AE across both groups, with the most common being general disorders and administration cite conditions. For infusion-related reactions, 60% in the biosimilar group and 63.53% experienced at least 1 AE, according to the investigators.¹

REFERENCES

1. Sahraian MA, Abolfazli R, Shaygannejad V, et al. Evaluating efficacy and safety of ocrelizumab biosimilar (Xacrel) compared to the originator (Ocrevus) in relapsing multiple sclerosis: a phase III, randomized, equivalency, clinical trial. Sci Rep. 2024;14(1):24921. Published 2024 Oct 22. doi:10.1038/s41598-024-75745-y

2. Flynn JP, Gerriets V. Ocrelizumab. [Updated 2023 Jun 26]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK547750/

3. Mayo Clinic. Multiple sclerosis. Updated November 1, 2024. Accessed November 6, 2024. https://www.mayoclinic.org/diseases-conditions/multiple-sclerosis/symptoms-causes/syc-20350269

4. Efficacy and Safety of Xacrel (Ocrelizumab) in Participants With Relapsing Remitting Multiple Sclerosis. ClinicalTrials.gov identification: NCT04966338. Updated October 18, 2022. Accessed November 6, 2024. https://clinicaltrials.gov/study/NCT04966338