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; Delamain, Marcia; Bar, Daniel; Beniwal, Surender; Dasappa, Lokanatha; Flores, David; Querol, John; Guan, Toh; Lipatov, Oleg; Volodicheva, Elena; Patel, Moosa; Nodehi, Sayyed; Fogliatto, Laura; Paravisini, Alexandra; Perez Diaz, Luis; Bhatt, N.; Bhattacharyya, S.; Mukhopadhyay, A.; Salvatierra, A.; Radhakrishnan, V.; Bhurani, D.; Jasuja, S.; Kowalyszyn, R.; da Silva Araujo, S.; Syafei, S.; Caffaro, J.; De Stefano, G.; Garcia, J.; Ciliao Munhoz, E.; Bermudez, C.; Gin, G.; Raman, R.; Villegas, E.; Martinez-Lapus, F.; Molina Barrios, G.; Tiangco, B.; Viktorovich, P.; Moiseevich, M.; Avila, G.; Munoz, M.; Saslavsky, M.; Beguelin, G.; Fogliatto, L.; Salvino de Araujo, A.; Pereira, J.; Rodrigues de Oliveira, J.; Luiz da Silva, R.; de Mattos, E.; Santi, P.; Debiasi, M.; Lazaretti, N.; Galvez, K.; Rosales, J.; Keat, C.; Uy, N.; Melnichenko, V.; Burdaeva, O.; Osmanov, D.; Bassa, F.; Jones, L.; Furque, M.; Bullorsky, E.; Heller, V.; Jarchum, G.; Basso, A.; Cigno, E.; Schaffel, R.; Boquimpani, C.; Meton, F.; Miguel, C.; Pinto Simoes, B.; Sampaio Tavares, R.; Franke, F.; Schmidt Filho, J.; Dantas da Cunha Junior, A.; Attili, A.; Kirushnakumar, K.; Chakrabarti, P.; Arumugan, V.; Fadjari, H.; Alekseev, S.; Ilyin, N.; Udovitsa, D.; Vladimirov, V.; Kaplanov, K.; Lysenko, I.; Ponomarev, R.; Lifirenko, I.; Szpak, W.; Loggetto, S.; Leao, D.; ÖZCAN, MEHMET; Michiels, S.; Florez, A.

doi:10.1080/10428194.2019.1633632

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 M., Gonzalez D. E., Delamain M. T., Bar D. O., Beniwal S. K., Dasappa L., ...Daha Fazla

LEUKEMIA & LYMPHOMA, cilt.60, sa.14, ss.3375-3385, 2019 (SCI-Expanded, Scopus)

Yayın Türü: Makale / Tam Makale
Cilt numarası: 60 Sayı: 14
Basım Tarihi: 2019
Doi Numarası: 10.1080/10428194.2019.1633632
Dergi Adı: LEUKEMIA & LYMPHOMA
Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus
Sayfa Sayıları: ss.3375-3385
Anahtar Kelimeler: Rituximab, RTXM83, biosimilar drug, diffuse large B-cell lymphoma, clinical trial
Dokuz Eylül Üniversitesi Adresli: Evet

Özet

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.