{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,10]],"date-time":"2026-07-10T14:17:06Z","timestamp":1783693026154,"version":"3.55.0"},"reference-count":22,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"5","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JGO"],"published-print":{"date-parts":[[2019,12]]},"abstract":"<jats:sec><jats:title>PURPOSE<\/jats:title><jats:p> We sought to compare the pharmacokinetics (PKs) of DRL-rituximab (DRL_RI; potential biosimilar) and innovator rituximab MabThera (Roche, Grenzach-Wyhlen, Germany; reference medicinal product [RMP]) in patients with diffuse large B-cell lymphoma (DLBCL). Efficacy, pharmacodynamics (PDs), safety, and immunogenicity were also compared. <\/jats:p><\/jats:sec><jats:sec><jats:title>PATIENTS AND METHODS<\/jats:title><jats:p> We conducted a double-blind, parallel-group study in patients with untreated DLBCL who were eligible to receive cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) therapy. Patients were randomly assigned at a one-to-one ratio to receive DRL_RI or RMP for six 21-day cycles of rituximab plus CHOP, with 18 months of follow-up after day 1, cycle 6 (C6). Primary end point was C1 PKs, measured as area under the plasma concentration\u2013time curve from day 0 to 21 (AUC<jats:sub>0-21 days<\/jats:sub>) and maximum plasma concentration (C<jats:sub>max<\/jats:sub>). Equivalence was defined as 90% CIs for the DRL_RI\/RMP geometric mean ratios (GMRs) within 80% and 125%. Secondary end points included efficacy noninferiority measured by objective response rate (ORR) at C6 and event-free survival and overall survival at 87 weeks, PK equivalence at C6 and PD equivalence (rate of B-cell depletion and repletion), safety, and immunogenicity. The trial was stopped after sufficient patients for primary end point evaluation were enrolled. Secondary end points are reported as observed. <\/jats:p><\/jats:sec><jats:sec><jats:title>RESULTS<\/jats:title><jats:p> A total of 151 patients were randomly assigned (DRL_RI, n = 76; RMP, n = 75). DRL_RI\/RMP GMRs for AUC<jats:sub>0-21 days<\/jats:sub> and C<jats:sub>max<\/jats:sub> in C1 were 99.77 (90% CI, 87.60 to 113.63) and 96.19 (90% CI, 88.65 to 104.38), respectively. ORR at C6 for DRL_RI and RMP were 82.0% and 84.8%, respectively. Rates of B-cell depletion\/repletion, immunogenicity, and adverse events were comparable in both groups. <\/jats:p><\/jats:sec><jats:sec><jats:title>CONCLUSION<\/jats:title><jats:p> DRL_RI and RMP had equivalent PKs, with comparable efficacy, PDs, safety, and immunogenicity. <\/jats:p><\/jats:sec>","DOI":"10.1200\/jgo.19.00248","type":"journal-article","created":{"date-parts":[[2019,12,6]],"date-time":"2019-12-06T20:58:28Z","timestamp":1575665908000},"page":"1-13","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":12,"title":["Randomized, Double-Blind, Pharmacokinetic Equivalence Trial Comparing DRL-Rituximab With MabThera in Patients With Diffuse Large B-Cell Lymphoma"],"prefix":"10.1200","author":[{"given":"Auro","family":"Viswabandya","sequence":"first","affiliation":[{"name":"Christian Medical College, Vellore, 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