KEY TAKEAWAYS
- The study aimed to assess the noninferiority of rituximab-abbs versus rituximab in patients with DLBCL on R-CHOP.
- Researchers found rituximab-abbs non-inferior to rituximab in patients with DLBCL on R-CHOP; long-term follow-up is needed.
Rituximab combined with cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) is a cornerstone treatment for diffuse large B-cell lymphoma (DLBCL), but the cost of rituximab represents a significant burden.
Rituximab-abbs, a biosimilar, offers a potential solution to reduce costs while maintaining efficacy. Despite its primary study in follicular lymphoma, the FDA has approved rituximab-abbs for all indications of the reference product (RP) through extrapolation. However, there is limited data on its use in DLBCL.
Helen W Wong and the team aimed to evaluate the effectiveness and safety of rituximab-abbs compared to the RP, rituximab, within the R-CHOP regimen for treating DLBCL.
They performed an inclusive analysis comparing the 2-year OS, overall response rate (ORR), and incidence of adverse events (AEs) between rituximab-abbs and its RP in R-CHOP treatment for adult patients with newly diagnosed DLBCL.
The study included patients diagnosed between January 1, 2019, and December 31, 2020. Analyses were conducted with a noninferiority margin of 10% for OS and ORR, and an upper limit of 10% for serious AEs.
About 240 patients received RP rituximab, while 295 patients were treated with rituximab-abbs. The cohort had a mean age of 63.7±12.2 years, with 43% being female. The 2-year overall survival (OS) rates were 81.0% for rituximab-abbs and 79.6% for rituximab (NI P < 0.01), and the ORR was 80.0% for rituximab-abbs and 69.6% for rituximab (NI P < 0.01). The incidence of infusion reaction AEs and noninfusion reaction AEs also demonstrated noninferiority (NI P < 0.01) for rituximab-abbs compared to the RP.
The study concluded that rituximab-abbs was non-inferior to rituximab in both effectiveness and safety for patients receiving R-CHOP for DLBCL. Long-term follow-up would be needed to confirm these results.
No funding information was provided.
Source: https://pubmed.ncbi.nlm.nih.gov/38935234/
Wong HW, Nguyen VH, Mok TY, et al. (2024). “Outcomes of Rituximab-abbs versus Rituximab in Patients with Diffuse Large B-Cell Lymphoma in a Noninferiority Study.” BioDrugs. 2024 Jul;38(4):601-610. doi: 10.1007/s40259-024-00666-1. Epub 2024 Jun 27. PMID: 38935234.
