Real-world use of bevacizumab-awwb, a bevacizumab biosimilar, in US patients with metastatic colorectal cancer

Rhodes, Whitney; DeClue, Richard W; Accortt, Neil A.; Jin, Ran; Sandschafer, Darcie; Wertz, Debra; Patel, Karan

doi:10.2217/fon-2021-0588

Cited by 12 publications

(9 citation statements)

References 22 publications

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“…Missing data were not imputed and were reported as 'undocumented' or 'unknown.' 29 PFS and OS probability and time to event outcomes, along with their associated 95% confidence intervals (CIs), were analyzed using Kaplan-Meier curves. The incidence at which each EOI occurred was described at patient level according to the management action(s) for the EOI.…”

Section: Discussionmentioning

confidence: 99%

“…29–32 Patient baseline characteristics were abstracted from unstructured EMRs by trained clinical research nurses and linked to patient data extracted from standard fields as described previously. 29 Treatment patterns of bevacizumab-awwb were collected, including durations of 1L bevacizumab-awwb use, prior treatment history of RP, and other systemic anticancer therapy (chemotherapy or immunotherapy). The occurrence and date of disease progression were determined from pathology reports, radiological scan notes, and/or statements about disease progression in oncologist progress notes.…”

Section: Methodsmentioning

confidence: 99%

“…As a result, practice patterns reflect real-world variability of treatment. [29][30][31][32] A retrospective medical chart review was conducted to evaluate patient characteristics and treatment outcome data. [29][30][31][32] Patient baseline characteristics were abstracted from unstructured EMRs by trained clinical research nurses and linked to patient data extracted from standard fields as described previously.…”

Section: Study Design and Data Collectionmentioning

confidence: 99%

“…The initial descriptive analysis evaluated patient clinical characteristics and utilization patterns of bevacizumab-awwb, reporting that ~80% of patients received bevacizumab-awwb as first-line (1L) therapy either as initiating bevacizumab therapy or as continuing bevacizumab therapy (switched from the RP). 29 In the current analysis, we followed those 1L patients longitudinally and aimed to evaluate clinical outcomes (events of interest [EOIs] and survival outcomes) of patients treated with 1L bevacizumab-awwb.…”

Section: Introductionmentioning

confidence: 99%

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Real-world outcomes among patients with metastatic colorectal cancer treated first line with a bevacizumab biosimilar (bevacizumab-awwb)

et al. 2023

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Background: Bevacizumab-awwb (MVASI®) was the first U.S. Food and Drug Administration-approved biosimilar to Avastin® (reference product [RP]) for the treatment of several different types of cancers, including metastatic colorectal cancer (mCRC), an indication approved based on extrapolation. Objectives: Evaluate treatment outcomes in mCRC patients who received first-line (1L) bevacizumab-awwb at treatment initiation or as continuing bevacizumab therapy (switched from RP). Design: A retrospective chart review study. Methods: Adult patients who had a confirmed diagnosis of mCRC (initial presentation of CRC on or after 01 January 2018) and initiated 1L bevacizumab-awwb between 19 July 2019 and 30 April 2020 were identified from the ConcertAI Oncology Dataset. A chart review was conducted to evaluate patient baseline clinical characteristics and effectiveness and tolerability outcomes during the follow-up. Study measures were reported stratified by prior use of RP: (1) naïve patients and (2) switchers (patients who switched to bevacizumab-awwb from RP without advancing the line of therapy). Results: At the end of study period, naïve patients ( n = 129) had a median 1L progression-free survival (PFS) of 8.6 months [95% confidence interval (CI), 7.6–9.9] and a 12-month overall survival (OS) probability of 71.4% (95% CI, 61.0–79.5%). Switchers ( n = 105) had a median 1L PFS of 14.1 months (95% CI, 12.1–15.8) and a 12-month OS probability of 87.6% (95% CI, 79.1–92.8%). During treatment with bevacizumab-awwb, 20 events of interest (EOIs) were reported in 18 naïve patients (14.0%) and 4 EOIs reported in 4 switchers (3.8%), of which the most commonly reported events were thromboembolic and hemorrhagic events. Most EOIs resulted in emergency department visit and/or treatment hold/discontinuation/switch. None of the EOIs resulted in death. Conclusion: In this real-world cohort of mCRC patients who were treated 1L with a bevacizumab biosimilar (bevacizumab-awwb), the clinical effectiveness and tolerability data were as expected and consistent with previously published findings from real-world studies of bevacizumab RP in mCRC patients.

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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Study Design and Data Collectionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Real-world outcomes among patients with metastatic colorectal cancer treated first line with a bevacizumab biosimilar (bevacizumab-awwb)

et al. 2023

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“…A retrospective, real-world study which had enrolled a total of 304 patients diagnosed with mCRC who initiated MVASI as rst-or later-line treatment, demonstrated that most patients (83%) experienced no disease progression between their last treatment with the reference product and the starting of treatment with a bevacizumab biosimilar [35] .…”

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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Biosimilars in Colorectal Cancer

Patel,

Nandpal,

Parekh

et al. 2024

Biosimilars for Cancer Treatment

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Real-world use of bevacizumab-awwb, a bevacizumab biosimilar, in US patients with metastatic colorectal cancer

Cited by 12 publications

References 22 publications

Real-world outcomes among patients with metastatic colorectal cancer treated first line with a bevacizumab biosimilar (bevacizumab-awwb)

Real-world outcomes among patients with metastatic colorectal cancer treated first line with a bevacizumab biosimilar (bevacizumab-awwb)

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

Biosimilars in Colorectal Cancer

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