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Rituximab biosimilar RTXM83 versus reference rituximab in combination with CHOP as first-line treatment for diffuse large B-cell lymphoma: a randomized, double-blind study

2019; Taylor & Francis; Volume: 60; Issue: 14 Linguagem: Inglês

10.1080/10428194.2019.1633632

1042-8194

Myrna Candelaria, Derlis Gonzalez, Márcia Torresan Delamain, Daniel Bär, Surender Beniwal, Lokanatha Dasappa, David Hugo Flores, J. Marruecos Querol, Toh See Guan, O. N. Lipatov, Elena Volodicheva, Moosa Patel, Sayyed Reza Safaee Nodehi, Laura Fogliatto, Alexandra Paravisini, L. Pérez Díaz,

Biosimilars and Bioanalytical Methods

This multicenter, double-blind, randomized study compared the efficacy, pharmacokinetics (PKs)/pharmacodynamics (PDs), safety and immunogenicity profile of RTXM83 vs. reference rituximab (R-rituximab), both with CHOP, as first-line treatment of diffuse large B-cell lymphoma (DLBCL). A total of 272 patients <65 years of age, with good prognosis (136 per arm) were randomized (1:1) to receive six cycles of either RTXM83 or R-rituximab. The primary efficacy endpoint was achieved (overall response rate of 83.6% for RTXM83 and 82.9% for R-rituximab) with a difference 0.7% between arms (95%CI: [–8.77% to 10.17%]) fulfilling the predefined non-inferiority margin (–13%). Similar number of patients reported at least one adverse event (AE) (131 per arm) or one serious AE (47 with RTXM83 and 45 with R-rituximab). Anti-drug antibody development was comparable between the arms. PK/PD secondary endpoint results support similarity between the compounds. RTXM83 exhibits non-inferior efficacy and similar safety/immunogenicity to R-rituximab, being an accessible alternative for the treatment of patients with previously untreated DLBCL.