Long-term efficacy and safety of CT-P10 or rituximab in untreated advanced follicular lymphoma: a randomized phase 3 study

Abstract

Rituximab biosimilars are a cornerstone of treatment of advanced-stage follicular lymphoma (FL). This double-blind, parallel-group, phase 3 trial randomized (1:1) adults (≥18 years) with stage III to IV indolent B-cell lymphoma, including grades 1 to 3a FL, to receive CT-P10 or rituximab (375 mg/m2 IV), with cyclophosphamide, vincristine, and prednisone, every 3 weeks for 8 cycles (induction period). Patients achieving complete response (CR), unconfirmed CR, or partial response (PR) received CT-P10 or rituximab maintenance for 2 years (375 mg/m2, every 8 weeks). Primary end points were previously reported, proving noninferiority of efficacy and pharmacokinetic equivalence of CT-P10 to rituximab. Secondary end points included overall response rate (PR+CR) during the induction period per 2007 International Working Group (IWG) criteria, survival analyses, and overall safety. Between 28 July 2014 and 29 December 2015, 140 patients were randomized (70 per group). Median follow-up was 39.9 months (interquartile range, 36.7-43.5). Per 1999 IWG criteria, 4-year Kaplan-Meier estimates (95% confidence interval [CI]) for CT-P10 and rituximab were 61% (47% to 73%) and 55% (36% to 70%) for progression-free survival (hazard ratio, 1.33 [95% CI, 0.67-2.63]; P=.409), respectively, and 88% (77% to 94%) and 93% (83% to 97%) for overall survival (5.29 [0.84-33.53]; P=.077). Overall, 90% (CT-P10) and 86% (rituximab) of patients experienced treatment-emergent adverse events. Long-term safety profiles were similar between groups. Findings confirm favorable outcomes for CT-P10–treated patients with advanced-stage FL and demonstrate comparable long-term efficacy and overall safety between CT-P10 and rituximab. This trial was registered at www.clinicaltrials.gov as #NCT02162771.

Analysis of 78 Cases of Primary Gastrointestinal Lymphoma

“…Since its introduction, anti-CD20 monoclonal antibody (Rituximab) has reshaped the treatment of follicular lymphoma (FL). Studies by Christian Buske and other scholars [ 13 ] show that CT-P10, a generic drug of rituximab, is similar to rituximab in therapeutic effect and drug safety, and its cost is relatively low.…”

Safety and efficacy comparisons of rituximab biosimilars to the reference product in patients with cancer: a systematic meta‐analysis review

“…Twenty‐nine studies 13,15–21,25,26,28–30,32,34–37,39–47 reporting on RCTs were identified and included in the analysis, with 26 studies reporting efficacy outcomes (Table 2). Among all included studies, two reported on ABP 798, 17,18 two reported on BCD‐020, 28,41 eight reported on CT‐P10, 16,26,29–31,36,37,39,40 two reported on DRL‐Rituximab, 42,46 two studies reported on GP2013, 34,35 three reported on HLX01, 20,43,44 three reported on IBI301, 15,21,38 one reported on PF‐05280586, 19 two reported on RTXM83, 13,32,33 one reported on SAIT101, 25 and one reported on Zytux 45 (Table 2). All studies reported on treatment naïve patients, except for one study that reported on a single switch 16 …”

“…Of 29 studies included for rituximab, seven studies also involved treatment with cyclophosphamide, vincristine, and prednisolone (CVP), 26,[29][30][31][34][35][36][37] nine studies involved treatment with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP), 13,20,21,32,33,38,[42][43][44]46 and 10 studies involved rituximab monotherapy [15][16][17][18][19]25,28,[39][40][41] (Table 2). One study involved rituximab as part of fludarabine, cyclophosphamide, and rituximab (FCR) treatment.…”

“…Twenty-nine studies 13,[15][16][17][18][19][20][21]25,26,[28][29][30]32,[34][35][36][37][39][40][41][42][43][44][45][46][47] reporting on RCTs were identified and included in the analysis, with 26 studies reporting efficacy outcomes (Table 2). Among all included studies, two reported on ABP 798, 17,18 two reported on BCD-020, 28,41 eight reported on CT-P10, 16,26,[29][30][31]36,37,39,40 two reported on DRL-Rituximab, 42,46 two studies reported on GP2013, 34,35 three reported on HLX01, 20,43,44 three reported on IBI301, 15,…”

Interchangeability and adverse events in originator-rituximab and its biosimilar (CT-P10) among rheumatic patients: a real-life experience

“…Therefore, to accept biosimilars as interchangeable, comparable preclinical and clinical studies must be presented, and it must be shown that the switch from reference drug to biosimilar does not affect patient safety and treatment effectiveness [8]. Indeed, the CT-P10 has been licensed by the European Medicine Agency (EMA) and the Food and Drug Administration (FDA) on the result of data in clinical and preclinical comparability studies in patients with non-Hodgkin lymphoma and RA [9,10]. Additionally, randomized controlled trials have demonstrated the bioequivalence of CT-P10 and oRTX in terms of efficacy, safety, and immunogenicity, as well as pharmacokinetics and pharmacodynamics properties [11][12][13][14].…”