Phase 3 Trial of BI 695502 Plus Chemotherapy Versus Bevacizumab Reference Product Plus Chemotherapy in Patients With Advanced Nonsquamous NSCLC

Kim, Edward S.; Balser, Sigrid; Röhr, Klaus; Lohmann, Ragna; Liedert, Bernd; Schliephake, Dorothee

doi:10.1016/j.jtocrr.2021.100248

Cited by 4 publications

(14 citation statements)

References 36 publications

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“…Of those, 37 RCTs were published in journals, 32-35,37-50,52-70 1 was reported in ClinicalTrials.gov, 51 and 1 was reported in an NMPA review. 36 Of the 39 RCTs, 18 studied bevacizumab biosimilars, [32][33][34][35][36][37][38][39][40][41][42][43][44][45][46][47][48][49] 12 studied rituximab biosimilars, 50-61 and 9 studied trastuzumab biosimilars. [62][63][64][65][66][67][68][69][70] Of the RCTs, 33 were prespecified as equivalence designs, [32][33][34][35][36][37][38][39][40][41][42][43][44][46][47][48][49][50][51][52][53][54][55]58,60,…”

Section: Rct and Cohort Study Characteristicsmentioning

confidence: 99%

“…The median duration for assessing the primary efficacy end points was 18 weeks (IQR, 18-21 weeks) for bevacizumab biosimilars, 23 weeks (IQR, 23-24 weeks) for rituximab biosimilars, and 24 weeks (IQR, 23-24 weeks) for trastuzumab biosimilars. Thirty-four RCTs reported the incidence of antidrug JAMA Network Open | Health Policy antibodies, [32][33][34][35][36][37][38][39][40][41][42][43][45][46][47][48][49][50][51][52][53][54][55][56][58][59][60][62][63][64][66][67][68]70 and 28 reported the incidence of neutralizing antibodies. [32][33][34][35][36][37][38][39][40][41][42][43][47][48][49][50][51][52][53]…”

Section: Rct and Cohort Study Characteristicsmentioning

confidence: 99%

“…Meta-analysis of 16 RCTs [32][33][34][35][36][37][38][39][40][41][42]44,[46][47][48][49] showed that the primary efficacy end point (ORR) of bevacizumab biosimilars was comparable to that of the reference drugs in the treatment of NSCLC (risk ratio [RR], 0.97; 95% CI, 0.93-1.01; P = .17) (eFigure 3 in Supplement 1). No significant differences in the primary efficacy end point of PFS rate (RR, 0.92; 95% CI, 0.78-1.07; P = .27) or PFS (HR, 0.79; 95% CI, 0.46-1.35; P = .47) between bevacizumab biosimilars and the reference drugs were observed among patients with metastatic colorectal cancer.…”

Section: Clinical Benefit Of Bevacizumab Biosimilars Vs Bevacizumabmentioning

confidence: 99%

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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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Section: Rct and Cohort Study Characteristicsmentioning

confidence: 99%

Section: Rct and Cohort Study Characteristicsmentioning

confidence: 99%

Section: Clinical Benefit Of Bevacizumab Biosimilars Vs Bevacizumabmentioning

confidence: 99%

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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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“…According to the pre-set search strategy, a total of 147 results were found, and 97 duplicate references were excluded. After reviewing the full text of the remaining 50 literatures, 10 randomized controlled trials (RCTs) with 6,416 participants were finally included (29)(30)(31)(32)(33)(34)(35)(36)(37)(38). The detailed literature selection process was shown in Figure 1.…”

Section: Literature Searchmentioning

confidence: 99%

“…A total of ten studies were included to compare the clinical outcomes of biosimilars with those of the original bevacizumab. All of the studies reported the ORR of biosimilar bevacizumab and the original bevacizumab, and 7 studies (29)(30)(31)(32)(33)(34)38) reported the PFS and OS. Overall, there was no significant difference in ORR, PFS, or OS between biosimilar bevacizumab and original bevacizumab, whether the Chinese experiment or the multicenter experiment (Figures 3-5).…”

Section: Efficacymentioning

confidence: 99%

Comparison of efficacy and safety of bevacizumab biosimilar and original bevacizumab in non-squamous non-small cell lung cancer: a systematic review and meta-analysis

Xiao¹,

Zhang²,

Sun³

et al. 2022

Transl Cancer Res TCR

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Background Bevacizumab (Avastin ® ), a monoclonal antibody targeting vascular endothelial growth factor (VEGF)-A, is widely used in treating a variety of malignant tumors. Several biosimilars of bevacizumab have been developed and marketed with the expiration of bevacizumab’s patent. The objective of this study was to collate available data from head-to-head randomized controlled trials (RCTs) and evaluate the efficacy and safety of biosimilar bevacizumab compared with the bevacizumab (Avastin ® ) in patients with non-squamous non-small cell lung cancer (NSCLC). Methods Literature search of Web of Science, PubMed, Cochrane Library, EMBASE, and ClinicalTrials.gov was performed from inception until October 15, 2021. The efficacy outcome indicators were objective response rate (ORR), progression-free survival (PFS) and overall survival (OS). The occurrence of adverse events (AEs) was evaluated for safety outcome. Results Ten RCTs recruiting 6,416 patients with non-squamous NSCLC were included. All RCTs studies included the biosimilar bevacizumab group as the experimental group and the original bevacizumab group as the control group. The patients in the experimental group and control group received the same dose and duration of chemotherapy combined with carboplatin and paclitaxel. The results of meta-analysis showed that there were no significant differences in ORR [risk ratio (RR): 0.97, 95% confidence interval (95% CI): 0.93–1.02. P=0.841, I 2 =0], PFS (RR: 1.04, 95% CI: 0.98–1.10, P=0.235, I 2 =0) and OS (RR: 1.05, 95% CI: 1.00–1.10, P=0.692, I 2 =0) between the biomarker and original groups. The P values of ORR, PFS and OS were 0.533, 0.970 and 0.916 respectively as shown by Egger's test, suggesting that there was no publication bias. Subgroup analysis showed no significant differences in ORR, PFS, and OS between the Chinese and multicenter trials. The pooled incidence rate of AEs between two groups was similar, and there was also no significant difference between the two groups. Discussion This is the first study to independently report biosimilar bevacizumab in a meta-analysis on NSCLC treatment. The results showed that biosimilar bevacizumab had similar efficacy and safety compared with the original bevacizumab. Trial Registration PROSPERO registration No. CRD42021276991.

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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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Phase 3 Trial of BI 695502 Plus Chemotherapy Versus Bevacizumab Reference Product Plus Chemotherapy in Patients With Advanced Nonsquamous NSCLC

Cited by 4 publications

References 36 publications

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

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

Comparison of efficacy and safety of bevacizumab biosimilar and original bevacizumab in non-squamous non-small cell lung cancer: a systematic review and meta-analysis

Biosimilar monoclonal antibodies for cancer treatment in adults

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