Clinical and treatment characteristics of patients treated with the first therapeutic oncology biosimilars bevacizumab-awwb and trastuzumab-anns in the US

Jin, Ran; Mahtani, Reshma; Accortt, Neil A.; Lawrence, T.; Sandschafer, Darcie; Loaiza‐Bonilla, Arturo

doi:10.1177/17588359211041961

Cited by 10 publications

(3 citation statements)

References 26 publications

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“…In Taiwan, a switching policy has not been fully established, however a physician could prescribe a biosimilar product to an eligible patient who received prior reference product treatment, provided that a comprehensive clinical evaluation and the process of informed consent was ensured. Jin R, et al had conducted the rst study to describe the real-world utilization of MVASI from the rst 12months following market entry across all approved tumor types in both RP-naïve patients and patients, with no distinctive differences in patient characteristics between the two groups [34] .…”

Section: Treatment Patterns and Clinical Outcomesmentioning

confidence: 99%

Clinical Response and Safety of Bevacizumab-awwb treatment in Patients with Metastatic Colorectal Cancer: A case series and review of the literature

Hung

Chen

2022

Preprint

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Background: Bevacizumab-awwb (MVASI®) is the first and the only bevacizumab biosimilar made available in Taiwan. However, its extrapolation of indication and the lack of available real-world clinical data has raised some concern. This article is aimed at presenting our real-world experience in the use of MVASI for treating patients with metastatic Colorectal Cancer (mCRC) for purposes of evaluating tumor response and safety. Materials & Methods: Adult patients from a single institution initiating MVASI use following an mCRC diagnosis during the period of May 2020 to August 2021 were included in the study. Each patient's demographics and tumor characteristics were collated retrospectively. We described treatment patterns and evaluated treatment efficacy stratified by initiating MVASI as either first line or later line therapy. Results: A total of 20 patients were identified, with 2 being excluded due to incomplete therapy and lost follow-up. The mean age of the subjects was 58.7 years. Most patients had a left-sided colorectal tumor (83.3%) and underwent a primary tumor resection (94%) prior to systemic antineoplastic therapy. Fourteen out of 18 patients initiated MVASI use as first line therapy, where the Disease-control Rate (DCR) was 85.7%. Alternatively, four out of 18 patients in later line therapy all experienced disease progression, with progression-free survival (PFS) ranging 4 to 10 months. Five patients had prior bevacizumab reference product utilization but switched to MVASI mostly due to economic issues, with three of these patients (60%) showing progression disease (PFS ranging 3-10 months). Only two patients (11%) encountered adverse events during MVASI therapy. Conclusion: Both the efficacy and safety of MVASI in the mCRC population are deemed comparable with the bevacizumab reference product, exclusively at first line therapy. The strategy of switching between the biosimilar and reference product is currently controversial, and therefore further studies are still required.

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Section: Treatment Patterns and Clinical Outcomesmentioning

confidence: 99%

Clinical Response and Safety of Bevacizumab-awwb treatment in Patients with Metastatic Colorectal Cancer: A case series and review of the literature

Hung

Chen

2022

Preprint

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“…However, no clinical data has verified the efficacy and safety of this biosimilar in clinical application. Existing trials ( 15 – 17 ) have excluded patients receiving previous treatment, patients receiving combination with targeted therapy or immunotherapy, patients with brain metastases, patients with rare genetic mutations (such as EML4-ALK rearrangement), and patients with Eastern Cooperative Oncology Group (ECOG) scores greater than 2. The efficacy and safety of bevacizumab biosimilar have no concensus in these populations.…”

Section: Introductionmentioning

confidence: 99%

Efficacy and safety of bevacizumab biosimilar compared with reference bevacizumab in locally advanced and advanced non-small cell lung cancer patients: A retrospective study

Zhao

Zhao²,

Xia³

et al. 2023

Front. Oncol.

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BackgroundBevacizumab has played an important role in the systemic treatment of patients with advanced non-small-cell lung cancer (NSCLC) without gene mutation. In recent years, bevacizumab biosimilar has received marketing approval based on the results of phase III clinical studies. However, more clinical data are needed to verify the efficacy and safety of bevacizumab biosimilar in clinical application.Materials and methodsWe identified 946 patients with locally advanced or metastatic NSCLC who were treated with bevacizumab biosimilar or bevacizumab from January 1, 2019 to November 30, 2021. Comparisons and statistical analyses of bevacizumab biosimilar and bevacizumab were made in terms of efficacy and safety. Efficacy evaluation was performed directly in accordance with RECIST v1.1. Adverse events were graded following the National Cancer Institute Common Terminology Criteria for Adverse Events v5.0.ResultsThe objective response rates (ORRs) were 28.9% in the biosimilar group (n=551) and 30.9% in the reference group (n=395; unstratified ORR risk ratio: 0.934, 95% confidence interval [CI]: 0.677–1.138; unstratified ORR risk difference: −0.020, 95% CI: −0.118–0.035). The estimated median progression-free survival (mPFS) were 6.27 (95% CI: 5.53–7.01) and 4.93 (95% CI: 4.24–5.62) months in the biosimilar and reference groups, respectively (P=0.296). The number of treatment lines, combined treatment regimens and with or without radiotherapy were significant factors affecting the PFS of both groups (P<0.001, P=0.001, P=0.039). Different genetic mutations and dose intensity were not the main factors affecting PFS (P=0.627, P=0.946). The incidences of treatment-emergent adverse events (TEAEs) were 76.41% in the biosimilar group and 71.65% in the reference group (P=0.098). The incidences of grade 3 or higher TEAEs were 22.14% and 19.49% in the biosimilar and reference groups, respectively (P=0.324).ConclusionsBevacizumab biosimilar is equivalent in efficacy to bevacizumab in patients with locally advanced and advanced NSCLC. It showed acceptable toxicity profile and no new adverse events. Patients who were excluded by clinical trials can also benefit from bevacizumab biosimilar.

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“…However, no clinical data has veri ed the e cacy and safety of this biosimilar in clinical application. Existing trials (Jin et al, 2021;Luo et al, 2022;Yang et al, 2021) have excluded patients receiving previous treatment, patients receiving combination with targeted therapy or immunotherapy, patients with brain metastases, patients with rare genetic mutations (such as EML4-ALK rearrangement), and patients with Eastern Cooperative Oncology Group (ECOG) scores greater than 2. The e cacy and safety of bevacizumab biosimilar have no concensus in these populations.…”

Section: Introductionmentioning

confidence: 99%

Efficacy and safety of bevacizumab biosimilar compared with reference bevacizumab in locally advanced and advanced non-small cell lung cancer patients: A retrospective study

Zhao

Xia

et al. 2022

Preprint

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PurposeBevacizumab is important in the systemic treatment of patients with advanced non-small-cell lung cancer (NSCLC) without gene mutation. Bevacizumab biosimilar has received marketing approval based on the results of phase III clinical studies. It is the first retrospective study to verify the efficacy and safety of bevacizumab biosimilar in clinical application.Methods We identified 946 patients with locally advanced or metastatic NSCLC treated with bevacizumab biosimilar or bevacizumab. Efficacy evaluation was performed according to RECIST v1.1. Adverse events were graded following the CTCAE v5.0. ResultsThe objective response rates (ORRs) were 28.9% in the biosimilar group (n=551) and 30.9% in the reference group (n=395; unstratified ORR risk ratio: 0.934, 95% confidence interval [CI]: 0.677–1.138). The estimated median progression-free survival (mPFS) were 6.27 (95% CI: 5.53–7.01) and 4.93 (95% CI: 4.24–5.62) months, respectively (p=0.296). The number of treatment lines, combined treatment regimens and with or without radiotherapy were significant factors affecting the PFS of both groups (p<0.001, p=0.001, p=0.039). Different genetic mutations and dose intensity were not the main factors (p=0.627, 0.946). The incidences of treatment-emergent adverse events (TEAEs) were 76.41% in the biosimilar group and 71.65% in the reference group (p=0.098). The incidences of grade 3 or higher TEAEs were 22.14% and 19.49%, respectively (p=0.324). ConclusionBevacizumab biosimilar is equivalent in efficacy to bevacizumab in patients with locally advanced and advanced NSCLC. It showed acceptable toxicity profile and no new adverse events. Patients who were excluded by clinical trials can also benefit from bevacizumab biosimilar.

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Clinical and treatment characteristics of patients treated with the first therapeutic oncology biosimilars bevacizumab-awwb and trastuzumab-anns in the US

Cited by 10 publications

References 26 publications

Clinical Response and Safety of Bevacizumab-awwb treatment in Patients with Metastatic Colorectal Cancer: A case series and review of the literature

Clinical Response and Safety of Bevacizumab-awwb treatment in Patients with Metastatic Colorectal Cancer: A case series and review of the literature

Efficacy and safety of bevacizumab biosimilar compared with reference bevacizumab in locally advanced and advanced non-small cell lung cancer patients: A retrospective study

Efficacy and safety of bevacizumab biosimilar compared with reference bevacizumab in locally advanced and advanced non-small cell lung cancer patients: A retrospective study

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