Real-World Evidence for Comparative Outcomes between Innovator and Biosimilar Bevacizumab in Advanced Colorectal Cancers.

IF 0.6 Q4 ONCOLOGY South Asian Journal of Cancer Pub Date : 2025-03-06 eCollection Date: 2024-10-01 DOI:10.1055/s-0045-1804535

Arvind Vaidyanathan, Pranaya Vana, Nachiket Joshi, Bikash Sourav, Prabhat Bhargava, George John, Anant Ramaswamy, Vikas Ostwal

{"title":"Real-World Evidence for Comparative Outcomes between Innovator and Biosimilar Bevacizumab in Advanced Colorectal Cancers.","authors":"Arvind Vaidyanathan, Pranaya Vana, Nachiket Joshi, Bikash Sourav, Prabhat Bhargava, George John, Anant Ramaswamy, Vikas Ostwal","doi":"10.1055/s-0045-1804535","DOIUrl":null,"url":null,"abstract":"Purpose: Generic versions of bevacizumab are commonly used in India in patients with advanced/metastatic colorectal cancers (mCRCs), but there is limited real-world evidence (RWE) about their efficacy in comparison to the innovator bevacizumab.Methods: Patients diagnosed with mCRC between January 2017 and January 2022 and receiving a combination of chemotherapy and bevacizumab were retrospectively analyzed for demographic variables and survivals. The primary endpoint of the study was the estimation and comparison of median progression-free survival (mPFS) between patients receiving innovator versus generic bevacizumab as first-line therapy (CT1) by the Kaplan-Meier method.Results: A total of 944 patients were included in the analysis, of whom 652 patients (69%) received bevacizumab as CT1, 449 patients (48%) during second-line chemotherapy (CT2), and 74 patients (8%) during third-line therapy (CT3). The innovator was administered to 132 patients (14%), while the remaining 812 patients (86%) received a generic molecule. With a median follow-up of 18 months, there was no difference in mPFS between patients receiving the innovator or biosimilar (10 vs. 9.3 months, p = 0.62). Similarly, there was no difference in median overall survival (mOS) between patients receiving the innovator or biosimilar during CT1 (17.8 vs. 18 months, p = 0.85). Among the patients who received bevacizumab during CT2, there was no statistically significant difference in mPFS between the innovator and the biosimilar (5.5 vs. 5.8 months, p = 0.97), nor was there a difference in mOS between patients receiving the innovator or biosimilar during CT2 (8.15 vs. 8.58 months, p = 0.16).Conclusion: The current study offers RWE to suggest similar outcomes with innovator and generic bevacizumab when combined with chemotherapy in mCRCs. This has significant implications in India and other low- and middle-income countries besides providing oncologists with greater confidence to use these molecules in their clinical practice.","PeriodicalId":22053,"journal":{"name":"South Asian Journal of Cancer","volume":"13 4","pages":"296-299"},"PeriodicalIF":0.6000,"publicationDate":"2025-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11888807/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"South Asian Journal of Cancer","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1055/s-0045-1804535","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/10/1 0:00:00","PubModel":"eCollection","JCR":"Q4","JCRName":"ONCOLOGY","Score":null,"Total":0}

引用次数: 0

Abstract

Purpose: Generic versions of bevacizumab are commonly used in India in patients with advanced/metastatic colorectal cancers (mCRCs), but there is limited real-world evidence (RWE) about their efficacy in comparison to the innovator bevacizumab.

Methods: Patients diagnosed with mCRC between January 2017 and January 2022 and receiving a combination of chemotherapy and bevacizumab were retrospectively analyzed for demographic variables and survivals. The primary endpoint of the study was the estimation and comparison of median progression-free survival (mPFS) between patients receiving innovator versus generic bevacizumab as first-line therapy (CT1) by the Kaplan-Meier method.

Results: A total of 944 patients were included in the analysis, of whom 652 patients (69%) received bevacizumab as CT1, 449 patients (48%) during second-line chemotherapy (CT2), and 74 patients (8%) during third-line therapy (CT3). The innovator was administered to 132 patients (14%), while the remaining 812 patients (86%) received a generic molecule. With a median follow-up of 18 months, there was no difference in mPFS between patients receiving the innovator or biosimilar (10 vs. 9.3 months, p = 0.62). Similarly, there was no difference in median overall survival (mOS) between patients receiving the innovator or biosimilar during CT1 (17.8 vs. 18 months, p = 0.85). Among the patients who received bevacizumab during CT2, there was no statistically significant difference in mPFS between the innovator and the biosimilar (5.5 vs. 5.8 months, p = 0.97), nor was there a difference in mOS between patients receiving the innovator or biosimilar during CT2 (8.15 vs. 8.58 months, p = 0.16).

Conclusion: The current study offers RWE to suggest similar outcomes with innovator and generic bevacizumab when combined with chemotherapy in mCRCs. This has significant implications in India and other low- and middle-income countries besides providing oncologists with greater confidence to use these molecules in their clinical practice.

查看原文