Efficacy, pharmacokinetics, and safety of the biosimilar CT-P10 in comparison with rituximab in patients with previously untreated low-tumour-burden follicular lymphoma: a randomised, double-blind, parallel-group, phase 3 trial

Ogura, Michinori; Sancho, Juan‐Manuel; Cho, Seok Goo; Nakazawa, Hayakazu; Suzumiya, Junji; Tumyan, Gayane; Kim, Jin Seok; Lennard, Anne; Mariz, José; Ilyin, N. V.; Jurczak, Wojciech; Martinez, Anthony; Samoilova, Olga; Zhavrid, Edvard; Ruiz, Eduardo Yañez; Trněný, Marek; Popplewell, Leslie; Coiffier, Bertrand; Buske, Christian; Kim, Won Seog; Lee, Sang Joon; Lee, Sung Young; Bae, Young‐Hoon; Kwak, Larry W.

doi:10.1016/s2352-3026(18)30157-1

Cited by 56 publications

(75 citation statements)

References 21 publications

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“…Moreover, the most frequent TRAEs of grade 3 or worse were abnormal laboratory tests such as decreased neutrophil count and decreased WBC count. Consistent with the findings of the present study, a decreased neutrophil count was also the most frequent grade 3 or 4 TEAE in a previous study on CT-P10 in low-tumour-burden FL 20 . Since rituximab plays a therapeutic role by inducing the apoptosis of CD20-positive cells and the activation of complement-dependent and antibody-dependent cell cytotoxicity 26 , it is rarely possible that rituximab or its biosimilar would cause decreased neutrophil count and decreased WBC count.…”

Section: Discussionsupporting

confidence: 93%

“…These data collectively provided potent evidence that IBI301 was PK bioequivalent to the reference drug in NHL. Such similarities in PK have also been observed in other comparative studies on rituximab biosimilars in patients with different NHL subtypes, including CT-P10 and GP2013 in FL 20 – 22 and RTXM83 in DLBCL 23 . Moreover, the PK profile of Reditux, a rituximab biosimilar, was comparable to historical reports of rituximab in DLBCL 24 .…”

Section: Discussionsupporting

confidence: 78%

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Pharmacokinetics and safety of IBI301 versus rituximab in patients with CD20+ B-cell lymphoma: a multicenter, randomized, double-blind, parallel-controlled study

Jiang¹,

Ke²,

Zhang³

et al. 2020

Sci Rep

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This multicenter, randomized, double-blind, parallel-controlled trial aimed to compare the pharmacokinetics (PK) of IBI301 with rituximab in patients with CD20-positive (CD20 + ) B-cell lymphoma, who achieved a complete response/unconfirmed complete response after standard treatments. Patients were randomized (1:1) to receive IBI301 or rituximab (375 mg/m 2 , IV). Patients who continuously benefitted from the trial after the PK phase underwent the extension phase to receive up to three cycles of 3-month-cycle of rituximab/IBI301 maintenance therapy. PK was described using the area under the serum concentration–time curve from time zero to infinity (AUC 0-inf ), AUC from time zero to last quantifiable concentration (AUC 0-t ), and maximum serum concentration ( C max ). Pharmacodynamics (PD), incidence of adverse events and immunogenicity were evaluated. PK was defined equivalent, if 90% confidence intervals (CIs) for geometric mean ratios of PK endpoints fell within the margin of 0.8–1.25. Overall, 181 patients were enrolled in IBI301 ( n = 89) and rituximab ( n = 92) groups. Geometric mean ratios of AUC 0-inf , AUC 0-t , and C max were 0.91 (90% CI 0.85, 0.97), 0.91 (90% CI 0.86, 0.97), and 0.96 (90% CI 0.92, 1.01) between treatment groups, all within the bioequivalence range. Peripheral CD19 + and CD20 + B-cell counts were similar at each prespecified time point between the groups. No difference in immunogenicity was observed. The incidences of treatment-emergent adverse events (84.3% vs. 83.5%) and treatment-related AEs (56.2% vs. 61.5%) were comparable (IBI301 vs. rituximab). IBI301 was PK bioequivalent to rituximab in patients with CD20 + B-cell lymphoma. The PD, safety, and immunogenicity profiles of IBI301 were similar to those of rituximab.

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Section: Discussionsupporting

confidence: 93%

Section: Discussionsupporting

confidence: 78%

Pharmacokinetics and safety of IBI301 versus rituximab in patients with CD20+ B-cell lymphoma: a multicenter, randomized, double-blind, parallel-controlled study

Jiang¹,

Ke²,

Zhang³

et al. 2020

Sci Rep

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“…Whereas PFS and OS may be influenced by factors such as tumor burden and subsequent lines of therapy, ORR is a direct measure of drug antitumor activity and hence is considered a sensitive endpoint for detecting potential product-related differences between a biosimilar and reference product [29, 30]. Indeed, ORR has been used as the primary endpoint in comparative clinical studies of other oncology biosimilars [31–34]. Additionally, bevacizumab plus paclitaxel and carboplatin has a well-characterized safety and efficacy profile as first-line therapy for patients with advanced non-squamous NSCLC [8].…”

Section: Discussionmentioning

confidence: 99%

PF-06439535 (a Bevacizumab Biosimilar) Compared with Reference Bevacizumab (Avastin®), Both Plus Paclitaxel and Carboplatin, as First-Line Treatment for Advanced Non-Squamous Non-Small-Cell Lung Cancer: A Randomized, Double-Blind Study

Reinmuth

Bryl²,

Bondarenko

et al. 2019

BioDrugs

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BackgroundPF-06439535 is a bevacizumab biosimilar. We aimed to compare the efficacy and safety of PF-06439535 with that of reference bevacizumab (Avastin®) sourced from the EU (bevacizumab-EU), each with paclitaxel and carboplatin, in the first-line treatment of advanced non-squamous non-small-cell lung cancer (NSCLC).MethodsIn this double-blind, parallel-group study, we recruited patients from 159 centers in 27 countries. Participants were randomized 1:1 to receive PF-06439535 plus paclitaxel and carboplatin or bevacizumab-EU plus paclitaxel and carboplatin on day 1 of each 21-day cycle for 4–6 cycles, followed by blinded monotherapy with PF-06439535 or bevacizumab-EU until disease progression, unacceptable toxicity, withdrawal of consent, or the end of the study. Randomization was stratified by region, sex, and smoking history. The primary endpoint was objective response rate (ORR) in accordance with RECIST 1.1, based on responses achieved by week 19 and confirmed by week 25.ResultsBetween 21 May 2015 and 14 November 2016, 719 patients were randomized to the PF-06439535 group (n = 358) or the bevacizumab-EU group (n = 361). As of data cutoff for analysis of the primary endpoint (8 May 2017), 45.3% (95% confidence interval [CI] 40.01–50.57) of patients in the PF-06439535 group and 44.6% (95% CI 39.40–49.89) of patients in the bevacizumab-EU group achieved an objective response by week 19 that was confirmed by week 25. The unstratified ORR risk ratio was 1.015 (95% CI 0.863–1.193; 90% CI 0.886–1.163), and the unstratified ORR risk difference was 0.653% (95% CI − 6.608 to 7.908); all three CIs fell within pre-specified equivalence margins. Using final data after study completion (22 December 2017), no notable differences in progression-free survival or overall survival were observed between the groups. The most frequently reported grade 3 or higher treatment-emergent adverse events were hypertension, neutropenia, and anemia. There were no clinically meaningful differences in safety, pharmacokinetics, or immunogenicity across treatment groups.ConclusionAmong patients with advanced non-squamous NSCLC, PF-06439535 demonstrated similarity to bevacizumab-EU in terms of efficacy. Safety profiles for the two treatments were comparable.Trial RegistrationClinicalTrials.gov, NCT02364999.FundingPfizer.Electronic supplementary materialThe online version of this article (10.1007/s40259-019-00363-4) contains supplementary material, which is available to authorized users.

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“…CT-P10 (CELLTRION) was the first mAb biosimilar anticancer drug to gain international regulatory approval following the results of phase 3 trials (NCT02260804 and NCT02162771) in FL. 33,34 Other examples of rituximab biosimilars include GP2013, PF-05280586, and ABP798. GP2013 has also been approved in the European Union for its efficacy data from a phase 3 trial in FL (ASSIST-FL, NCT01419665).…”

Section: Cd20mentioning

confidence: 99%

Advances in targeted therapy for malignant lymphoma

Wang

Qin

Huo

et al. 2020

Sig Transduct Target Ther

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The incidence of lymphoma has gradually increased over previous decades, and it ranks among the ten most prevalent cancers worldwide. With the development of targeted therapeutic strategies, though a subset of lymphoma patients has become curable, the treatment of refractory and relapsed diseases remains challenging. Many efforts have been made to explore new targets and to develop corresponding therapies. In addition to novel antibodies targeting surface antigens and small molecular inhibitors targeting oncogenic signaling pathways and tumor suppressors, immune checkpoint inhibitors and chimeric antigen receptor T-cells have been rapidly developed to target the tumor microenvironment. Although these targeted agents have shown great success in treating lymphoma patients, adverse events should be noted. The selection of the most suitable candidates, optimal dosage, and effective combinations warrant further investigation. In this review, we systematically outlined the advances in targeted therapy for malignant lymphoma, providing a clinical rationale for mechanism-based lymphoma treatment in the era of precision medicine.Signal Transduction and Targeted Therapy (2020) 5:15; https://doi.

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Efficacy, pharmacokinetics, and safety of the biosimilar CT-P10 in comparison with rituximab in patients with previously untreated low-tumour-burden follicular lymphoma: a randomised, double-blind, parallel-group, phase 3 trial

Cited by 56 publications

References 21 publications

Pharmacokinetics and safety of IBI301 versus rituximab in patients with CD20+ B-cell lymphoma: a multicenter, randomized, double-blind, parallel-controlled study

Pharmacokinetics and safety of IBI301 versus rituximab in patients with CD20+ B-cell lymphoma: a multicenter, randomized, double-blind, parallel-controlled study

PF-06439535 (a Bevacizumab Biosimilar) Compared with Reference Bevacizumab (Avastin®), Both Plus Paclitaxel and Carboplatin, as First-Line Treatment for Advanced Non-Squamous Non-Small-Cell Lung Cancer: A Randomized, Double-Blind Study

Advances in targeted therapy for malignant lymphoma

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