Efficacy and Safety of CT-P10 Versus Rituximab in Untreated Low-Tumor-Burden Follicular Lymphoma: Final Results of a Randomized Phase III Study

Kwak, Larry W.; Sancho, Juan‐Manuel; Cho, Seok-Goo; Nakazawa, Hayakazu; Suzumiya, Junji; Tumyan, Gayane; Kim, Jin Seok; Menne, Tobias; Mariz, José; Ilyin, N. V.; Jurczak, Wojciech; Martinez, Anthony; Samoilova, Olga; Zhavrid, Edvard; Ruiz, Eduardo Yañez; Trněný, Marek; Popplewell, Leslie; Kim, Won-Seog; Lee, Sang Joon; Kim, Sung Hyun; Ahn, Kwangseog; Buske, Christian

doi:10.1016/j.clml.2021.08.005

Cited by 6 publications

(4 citation statements)

References 20 publications

(41 reference statements)

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“…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 …”

Section: Resultsmentioning

confidence: 99%

“…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.…”

Section: Included Studiesmentioning

confidence: 99%

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

Song

Musa

Soriano

et al. 2022

Pharmacy Practice and Res

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Aim: To compare the efficacy and safety of rituximab biosimilars to reference rituximab in patients with cancer. Data Sources: A systematic review and meta-analysis was conducted in accordance with PRISMA guidelines. MEDLINE, EMBASE, and Cochrane Central databases were searched from inception to 12 January 2022 to obtain all randomised control trial (RCTs) reporting on the safety and efficacy outcomes of patients with cancer treated with rituximab biosimilars. Study Selection: All RCTs comparing the reference rituximab with a biosimilar, conducted in inpatient and outpatient settings, were included in the systematic review. Results: Twenty-nine RCTs were identified to report on patients treated with rituximab. The odds of achieving overall response rate in patients treated with a rituximab biosimilar compared to the reference over at least 24 weeks of treatment was 1.06 (95% confidence interval [CI] 0.88-1.26). The proportion of patients experiencing any treatment emergent adverse events were comparable between the two study arms ). Conclusion: Biosimilars for rituximab have comparable efficacy and safety profiles in treatment na€ ıve patients; however, evidence for efficacy and safety of switching patients from reference biologic to biosimilar is lacking, and further research is required.

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Section: Resultsmentioning

confidence: 99%

Section: Included Studiesmentioning

confidence: 99%

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

Song

Musa

Soriano

et al. 2022

Pharmacy Practice and Res

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“…None of the reactions reported in these studies was considered serious, all resolved without causing any problems, and most occurred after the first infusion and within the first hour of infusion. The IRRs rates observed in phase 3 studies ranged between 15 and 32% for CT-P10 and 9.5-30% for oRTX [10,12,21,22]. Although real-life data are limited in studies with CT-P10, it has been reported that IRRs rates are 16-27% in patients with lymphoma [23,24], and about 10% in rheumatologic populations [25,26].…”

Section: Discussionmentioning

confidence: 99%

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

et al. 2023

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Biosimilars offer cost-effective and safe treatment options both for patients and healthcare systems. CT-P10 is the first biosimilar of rituximab approved in Europe for use in all indications of originator rituximab (oRTX). This study aimed to provide real-life data on treatment changes and adverse events in patients who received oRTX or CT-P10. We retrospectively reviewed treatment-related adverse events [infusion-related reactions (IRRs), infections, hypogammaglobulinemia] in patients treated with at least one dose of oRTX (MabThera ® ) or CT-P10 (Truxima ® ) between 2020 and 2021 and had at least 6 months follow-up after rituximab infusion in a rheumatology clinic. The switches between oRTX and CT-P10 were performed according to drug availability at the hospital pharmacy at the time of infusion according to the local hospital procedure. Physicians were not involved in the decision of biosimilar selection. A total of 128 patients (CT-P10, n = 64; oRTX, n = 64) were included. CT-P10 was switched in 52 (40.6%) patients who had previously used oRTX, and 48 (37.5%) patients remained on oRTX. We demonstrated no difference between patients treated with oRTX or CT-P10 in the rates of IRRs, in which all reactions were grade 1 and 2. Comparable rates of infections (p > 0.05) and the rate of hypogammaglobulinemia (p > 0.05) were found in both groups with no significant difference. CT-P10 provides a safe treatment alternative in patients who require rituximab therapy. The rational use of biosimilars can be supported by evolving evidence on interchangeability and switching in real-life settings, which will help clinicians in decision-making.

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“…This finding supported the clinical comparability of CT‐P10 and rituximab in patients with previously untreated advanced FL. Another randomized trial supported the therapeutic equivalence of CT‐P10 and rituximab and the use of CT‐P10 monotherapy as first‐line therapy for low tumor burden FL, which may provide significant cost savings 35 . In general, despite the lack of sufficient evidence for the effectiveness of CT‐P10, further studies with large samples may be required.…”

Section: Discussionmentioning

confidence: 99%

Maintenance and consolidation strategies for patients with untreated advanced follicular lymphoma: A systematic review and network meta‐analysis of randomized trials

Chu,

Liu,

et al. 2023

Cancer

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BackgroundThe emergence of novel and efficient antibody maintenance approaches has provided more options for post‐induction treatment of advanced follicular lymphoma (FL), and further comparisons are required to determine the most clinically beneficial regimen. The authors conducted a systematic review and meta‐analysis to evaluate the maintenance or consolidation strategy.MethodsThe authors performed two independent searches in PubMed, Web of Science, the Cochrane library databases, Scopus, and Embase for randomized controlled trials (RCTs) evaluating maintenance or consolidation therapy in untreated FL patients. Extracted data included the clinical characteristics, treatment regimen, progression‐free survival (PFS), overall survival (OS), and adverse effects. They then pooled the data and used a Bayesian random‐effects model to combine direct comparisons with indirect evidence.ResultsThe authors screened 1515 records and identified 13 eligible RCTs that assessed nine different regimens in 5681 advanced FL patients. Reconstructed individual survival data presented that obinutuzumab had the highest effect sizes and certainty of the evidence for PFS (hazard ratio, 0.43; 95% confidence interval, 0.22–0.79) and tolerability compared with observation. However, no benefit was observed in patients according to the OS, regardless of which regimen was taken. Considering other regimens, although an extended course of rituximab maintenance and consolidation therapies presented PFS benefits compared with standard rituximab maintenance, they were also associated with higher toxicity.ConclusionsAlthough obinutuzumab and rituximab maintenance treatment improved PFS significantly, its clinical benefit requires further validation in larger populations. Furthermore, because few trials informed each treatment comparison, research is needed to refine the understanding of this complex and rapidly evolving treatment landscape.

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Efficacy and Safety of CT-P10 Versus Rituximab in Untreated Low-Tumor-Burden Follicular Lymphoma: Final Results of a Randomized Phase III Study

Cited by 6 publications

References 20 publications

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

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

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

Maintenance and consolidation strategies for patients with untreated advanced follicular lymphoma: A systematic review and network meta‐analysis of randomized trials

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