Efficacy and Safety of the Biosimilar IBI301 Plus Standard CHOP (I-CHOP) in Comparison With Rituximab Plus CHOP (R-CHOP) in Patients with Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL): A Randomized, Double-Blind, Parallel-Group, Phase 3 Trial

Song, Yuqin; Zhou, Hui; Zhang, Huilai; Liu, Wei; Shuang, Yue-Rong; Zhou, Keshu; Lv, Fangfang; Xu, Hao; Zhou, Jianfeng; Li, Wei; Wang, Huaqing; Zhang, Hongyu; Huang, Haiwen; Zhang, Qingyuan; Xu, Wei; Ge, Zheng; Xiang, Ying; Wang, Shuye; Gao, Da; Yang, Shuanying; Lin, Jianhao; Wang, Lin; Zou, Liqun; Zheng, Meifang; Liu, Jing; Shao, Zonghong; Pang, Ying; Xia, Ruixiang; Chen, Zhendong; Hou, Ming; Yao, Hongxia; Ren, Feng; Zhang, Cai; Zhang, Mingzhi; Ran, Wenhua; Liu, Lin; Zeng, Shan; Yang, Wei; Liu, Peng; Liang, Aibin; Zuo, Xuelan; Zou, Qingfeng; Ma, Junxun; Sang, Wei; Guo, Ye; Cao, Yongqing; Li, Yan; Feng, Jifeng; Du, Xin; Zhang, Xiaohong; Zhao, Hongguo; Yu, Jie; Sun, Xiaofeng; Zhu, Jun; Qiu, Lugui

doi:10.1007/s12325-020-01603-8

Cited by 14 publications

(23 citation statements)

References 34 publications

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“…Most patients were treated for FL or DLBCL, and all patients besides those in one study 16 reported on patients who were treatment naïve. Figure 4a — forest plot — summarises results from 10 studies 15,19–21,25,26,30,33,34,41 involving 3066 patients (biosimilar n = 1528, reference n = 1538). Comparable incidence of patients experiencing at least one TEAE with the biosimilar of rituximab was similar to the reference (OR 1.20, 95% CI: 0.98–1.49, p = 0.08).…”

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%

“…12 A 2019 systematic review and metaanalysis by Lee et al 14 involved both rheumatoid arthritis patients and NHL patients; however, more evidence has emerged since then which is specifically relevant to the oncology setting. [15][16][17][18][19][20][21]…”

Section: Introductionmentioning

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%

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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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“…However, treatment options for those who relapse after ASCT, or cannot to undergo ASCT, are extremely challenging clinically and preclinically. In recent years, immunotherapy, molecularly targeted drugs, and combination therapy have tended to improve the survival of patients with B‐NHL 10,11 …”

Section: Introductionmentioning

confidence: 99%

“…In recent years, immunotherapy, molecularly targeted drugs, and combination therapy have tended to improve the survival of patients with B-NHL. 10,11 CD47 is a transmembrane receptor that is overexpressed in almost all cancer cells, which acts as a "do not eat me" signal to prevent clearance by macrophages or other phagocytes via binding signal regulatory protein alpha (SIRPα). 12 CD47 overexpression is an adverse prognostic predictor in patients with various types of cancer, including lymphoma.…”

mentioning

confidence: 99%

Anti‐CD47 immunotherapy in combination with BCL‐2 inhibitor to enhance anti‐tumor activity in B‐cell lymphoma

Heng

et al. 2022

Hematological Oncology

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CD47 expressed on cancer cells enables macrophage immune evasion. Blocking CD47 using anti‐CD47 monoclonal antibodies (mAbs) is a promising strategy. The anti‐CD47 mAb TJC4 has anti‐tumor activity but lacks hematological toxicity. Venetoclax, a B‐cell lymphoma 2 (BCL‐2) inhibitor for B‐cell malignancy, induces phosphatidylserine (PS) extracellular exposure, representing an “eat‐me” signal for macrophages. The present study aimed to explore whether TJC4‐Venetoclax combined therapy exerts synergistic anti‐cancer properties in B‐cell lymphoma. In vitro, flow cytometry and microscopy assessed whether TJC4 monotherapy or combination treatment could promote macrophage‐mediated phagocytosis of tumor cells. Induced PS exposure on the cell membrane was measured using flow cytometry with Annexin V‐FITC staining. In vivo, Venetoclax and TJC4's synergistic anti‐tumor effects were evaluated. B cell lymphoma cell lines express high levels of CD47 and patients with diffuse large B cell lymphoma expressing CD47 have a worse clinical prognosis. TJC4 eliminates tumor cells via macrophage‐mediated phagocytosis. In vitro and in vivo, the TJC4‐Venetoclax combination increased phagocytosis significantly compared with either agent alone, showing synergistic phagocytosis, and displayed synergistic anti‐cancer properties in B‐cell lymphoma. Our results support the TJC4‐Venetoclax combination as a promising therapy, and suppressing BCL‐2 and CD47 simultaneously could represent a novel therapeutic paradigm for B‐cell lymphoma.

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Clinical Benefit, Price, and Uptake for Cancer Biosimilars vs Reference Drugs in China

Luo,

Du,

et al. 2023

JAMA Netw Open

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ImportanceThe high cost of biologics used to treat cancer has been an increasing burden in the world. In China, the recent approval of cancer biosimilar drugs to resolve this problem is promising, but evidence of clinical benefits, price, and uptake for these drugs is still lacking.ObjectivesTo compare characteristics of pivotal clinical trials in China and other countries for biosimilars of bevacizumab, rituximab, and trastuzumab and investigate the efficacy or effectiveness, safety, and immunogenicity outcomes of cancer biosimilars compared with reference drugs by meta-analysis.Data SourcesFor this systematic review and meta-analysis, PubMed, Embase, the Cochrane Library, and ClinicalTrials.gov were searched for published studies from database inception to February 1, 2023, using the search topics (cancers) AND (biosimilars).Study SelectionRandomized clinical trials and cohort studies that included patients with cancer were included.Data Extraction and SynthesisTwo authors independently extracted the outcome estimates and characteristics for each study. A random-effects meta-analysis was performed to summarize the relative estimates with 95% CIs. This study was performed following the Preferred Reporting Items for Systematic Reviews and Meta-analyses guideline.Main Outcomes and MeasuresClinical trial characteristics were collected for biosimilars of bevacizumab, rituximab, and trastuzumab. The relative estimates of efficacy or effectiveness (objective response rate, progression-free survival, and overall survival), safety, and immunogenicity outcomes were analyzed for biosimilars vs reference drugs. The weighted average price and uptake rate were evaluated for biosimilars relative to their reference drugs between 2015 and 2022.ResultsA total of 39 RCTs (involving 18 791 patients) and 10 cohort studies (involving 1998 patients) were included. The biosimilars of bevacizumab (16 RCTs; risk ratio [RR], 0.97; 95% CI, 0.93-1.01; P = .17), rituximab (12 RCTs; RR, 1.03; 95% CI, 0.98-1.08; P = .70), and trastuzumab (9 RCTs: RR, 1.04; 95% CI, 0.97-1.12; P = .29) met equivalence with reference biologics in regard to the objective response rate. The results summarized from cohort studies were consistent with those from RCTs. In 2022, cancer biosimilars were priced at 69% to 90% of the costs for the reference drugs, and their uptake reached 54% to 83% in China.Conclusions and RelevanceThis systematic review and meta-analysis indicated that cancer biosimilars provided comparable clinical benefits at lower prices compared with reference drugs. These findings suggest the potential feasibility of expediting the transition from reference drugs to biosimilars to benefit more patients with cancer.

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Efficacy and Safety of the Biosimilar IBI301 Plus Standard CHOP (I-CHOP) in Comparison With Rituximab Plus CHOP (R-CHOP) in Patients with Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL): A Randomized, Double-Blind, Parallel-Group, Phase 3 Trial

Cited by 14 publications

References 34 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

Anti‐CD47 immunotherapy in combination with BCL‐2 inhibitor to enhance anti‐tumor activity in B‐cell lymphoma

Clinical Benefit, Price, and Uptake for Cancer Biosimilars vs Reference Drugs in China

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