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

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. Obj...

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Main Authors: Ran Jin, Adesuwa S. Ogbomo, Neil A. Accortt, Lincy S. Lal, Geetanjali Bishi, Darcie Sandschafer, Jerome H. Goldschmidt
Format: Article
Language:English
Published: SAGE Publishing 2023-06-01
Series:Therapeutic Advances in Medical Oncology
Online Access:https://doi.org/10.1177/17588359231182386
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author Ran Jin
Adesuwa S. Ogbomo
Neil A. Accortt
Lincy S. Lal
Geetanjali Bishi
Darcie Sandschafer
Jerome H. Goldschmidt
author_facet Ran Jin
Adesuwa S. Ogbomo
Neil A. Accortt
Lincy S. Lal
Geetanjali Bishi
Darcie Sandschafer
Jerome H. Goldschmidt
author_sort Ran Jin
collection DOAJ
description 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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spelling doaj.art-1e3bd947becc4f728269150e570d3bc42023-06-22T06:33:23ZengSAGE PublishingTherapeutic Advances in Medical Oncology1758-83592023-06-011510.1177/17588359231182386Real-world outcomes among patients with metastatic colorectal cancer treated first line with a bevacizumab biosimilar (bevacizumab-awwb)Ran JinAdesuwa S. OgbomoNeil A. AccorttLincy S. LalGeetanjali BishiDarcie SandschaferJerome H. GoldschmidtBackground: 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.https://doi.org/10.1177/17588359231182386
spellingShingle Ran Jin
Adesuwa S. Ogbomo
Neil A. Accortt
Lincy S. Lal
Geetanjali Bishi
Darcie Sandschafer
Jerome H. Goldschmidt
Real-world outcomes among patients with metastatic colorectal cancer treated first line with a bevacizumab biosimilar (bevacizumab-awwb)
Therapeutic Advances in Medical Oncology
title Real-world outcomes among patients with metastatic colorectal cancer treated first line with a bevacizumab biosimilar (bevacizumab-awwb)
title_full Real-world outcomes among patients with metastatic colorectal cancer treated first line with a bevacizumab biosimilar (bevacizumab-awwb)
title_fullStr Real-world outcomes among patients with metastatic colorectal cancer treated first line with a bevacizumab biosimilar (bevacizumab-awwb)
title_full_unstemmed Real-world outcomes among patients with metastatic colorectal cancer treated first line with a bevacizumab biosimilar (bevacizumab-awwb)
title_short Real-world outcomes among patients with metastatic colorectal cancer treated first line with a bevacizumab biosimilar (bevacizumab-awwb)
title_sort real world outcomes among patients with metastatic colorectal cancer treated first line with a bevacizumab biosimilar bevacizumab awwb
url https://doi.org/10.1177/17588359231182386
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