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
- Candelaria, Myrna
- Gonzalez, Derlis E.
- Delamain, Marcia Torresan
- Bar, Daniel Oscar
- Beniwal, Surender Kumar
- Dasappa, Lokanatha
- Flores, David Hugo
- Querol, John
- Guan, Toh See
- Lipatov, Oleg Nikolaevich
- Volodicheva, Elena Mikhailovna
- Patel, Moosa
- Nodehi, Sayyed Reza S
DOIAbstract
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 ar...
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