Equivalent efficacy of a biosimilar rituximab and reference rituximab in previously untreated advanced follicular lymphoma: Extended results of ASSIST-FL, a confirmatory phase III study

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 …”

“…Four abstracts were rated as having a moderate risk of bias for similar reasons with insufficient information being provided: lack of method of randomisation or method of blinding; and no statement about a statistical analysis plan. Four studies were assessed as being at high risk of bias 28,32,35,42 ; those studies were excluded from the meta-analysis but were checked for heterogeneity and publication bias (Table 2).…”

“…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.…”

“…Four abstracts were rated as having a moderate risk of bias for similar reasons with insufficient information being provided: lack of method of randomisation or method of blinding; and no statement about a statistical analysis plan. Four studies were assessed as being at high risk of bias 28,32,35,42 ; those studies were excluded from the meta-analysis but were checked for heterogeneity and publication bias (Table 2). 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).…”

ESMO 2017—my personal highlights

“…However, these are very small cohorts and future data have to be awaited. Of public interest was the final presentation of the ASSIST-FL study, providing evidence for biosimilarity of rituximab-generic GP2013 in the first-line treatment of advanced follicular lymphoma (abstract 994O, N treated patients = 637) [ 3 ]. The corresponding ORR in combination with chemo backbone CVP (cyclophosphamide, vincristine, prednisolone) was 87.1% in the GP2013 arm versus 87.5% in the rituximab cohort (ORR at week 24–0.4%; 95%CI −5.94 to +5.14%).…”