A Double‐blind, Randomized Phase 3 Study to Compare Efficacy and Safety of Ct‐p10 to Rituximab in Combination With CVP in Patients With Advanced‐stage Follicular Lymphoma

Buske, Christian; Kim, W.; Kwak, Larry W.; Jurczak, Wojciech; Sancho, Juan‐Manuel; Zhavrid, E.; Kim, J.; Rivas, José; Prokharau, Aliaksandr; Vasilică, Mariana; Nagarkar, Rajnish; Osmanov, Dzhelil; Lee, S.; Bae, Young‐Hoon

doi:10.1002/hon.2438_83

Cited by 3 publications

(6 citation statements)

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“…had the smallest trial with 70 participants, while Jurczak et al. had the largest trial with 858 participants 28,29 . All trials were conducted on patients who were commencing rituximab treatment for the first time, with the exception of one study by Kwak et al., 16 which involved a switch to biosimilar (CT‐P10) in some patients.…”

Section: Resultsmentioning

confidence: 99%

“…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%

“…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,…”

Section: Robrtx Study Outcomes: Efficacymentioning

confidence: 99%

“…Toogeh et al had the smallest trial with 70 participants, while Jurczak et al had the largest trial with 858 participants. 28,29 All trials were conducted on patients who were commencing rituximab treatment for the first time, with the exception of one study by Kwak et al, 16 which involved a switch to biosimilar (CT-P10) in some patients. Fifteen trials were conducted on patients with follicular lymphoma (FL), 11 trials involved patients with diffuse large B-cell lymphoma (DLBCL), two trials involved patients with an unknown subtype of NHL, and one trial involved patients with chronic lymphocytic leukaemia.…”

Section: Included Studiesmentioning

confidence: 99%

“…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). 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 r...…”

Section: Risk Of Biasmentioning

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: Resultsmentioning

confidence: 99%

Section: Robrtx Study Outcomes: Efficacymentioning

confidence: 99%

Section: Included Studiesmentioning

confidence: 99%

Section: Risk Of Biasmentioning

confidence: 99%

See 3 more Smart Citations

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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Biosimilar monoclonal antibodies for cancer treatment in adults

Galvao,

Livinalli,

Lopes

et al. 2024

Cochrane Database of Systematic Reviews

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Biosimilar monoclonal antibodies (mAbs) in oncology

Moore

2017

Br J Nurs

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Biological medicines are derived from living cells and organisms. Monoclonal antibodies (mAbs) are biological agents that are widely used to treat malignancies including non-Hodgkin's lymphomas and chronic lymphocytic leukaemia. They are effective but expensive. The patents for many mAbs are expiring, so biosimilar medicines, which contain a version of the active ingredient of the original drug, are being developed. Biological medicines cannot be assessed in the same way as standard generic medications because they are difficult to copy and can change over time. A pathway regulates how biosimilars are assessed and compared with the original drug to ensure they are highly similar and have no clinically meaningful differences in terms of structure, function, pharmacodynamics and mechanism of action, pharmacokinetic properties, clinical efficacy and safety. Truxima(rituximab), the first biosimilar monoclonal antibody to be approved for use in the UK in an oncology setting, is biosimilar to intravenous (IV) rituximab; rituximab improves the effectiveness of standard chemotherapy for lymphoma. The two drugs are comparable in efficacy and safety and have the same indications, dosing regimen and storage procedures.

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A Double‐blind, Randomized Phase 3 Study to Compare Efficacy and Safety of Ct‐p10 to Rituximab in Combination With CVP in Patients With Advanced‐stage Follicular Lymphoma

Cited by 3 publications

References 0 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

Biosimilar monoclonal antibodies for cancer treatment in adults

Biosimilar monoclonal antibodies (mAbs) in oncology

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