Jin Ran, Ogbomo Adesuwa S, Accortt Neil A, Lal Lincy S, Bishi Geetanjali, Sandschafer Darcie, Goldschmidt Jerome H
Amgen Inc., 1 Amgen Center Dr, Thousand Oaks, CA 91320, USA.
ConcertAI, Cambridge, MA, USA.
Ther Adv Med Oncol. 2023 Jun 21;15:17588359231182386. doi: 10.1177/17588359231182386. eCollection 2023.
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.
Evaluate treatment outcomes in mCRC patients who received first-line (1L) bevacizumab-awwb at treatment initiation or as continuing bevacizumab therapy (switched from RP).
A retrospective chart review study.
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).
At the end of study period, naïve patients ( = 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 ( = 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.
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.
贝伐单抗-awwb（MVASI）是美国食品药品监督管理局批准的首个与阿瓦斯汀（参比产品[RP]）生物相似的药物，用于治疗多种不同类型的癌症，包括转移性结直肠癌（mCRC），该适应症是基于外推法批准的。
评估在治疗开始时接受一线（1L）贝伐单抗-awwb或作为贝伐单抗持续治疗（从参比产品转换而来）的mCRC患者的治疗结果。
一项回顾性图表审查研究。
从ConcertAI肿瘤学数据集中识别出确诊为mCRC（2018年1月1日或之后首次出现CRC）且在2019年7月19日至2020年4月30日期间开始接受1L贝伐单抗-awwb治疗的成年患者。进行图表审查以评估患者基线临床特征以及随访期间的有效性和耐受性结果。研究指标按既往是否使用参比产品分层报告：（1）初治患者和（2）转换者（从参比产品转换为贝伐单抗-awwb但未升级治疗线的患者）。
在研究期结束时，初治患者（n = 129）的1L无进展生存期（PFS）中位数为8.6个月[95%置信区间（CI），7.6 - 9.9]，12个月总生存期（OS）概率为71.4%（95% CI，61.0 - 79.5%）。转换者（n = 105）的1L PFS中位数为14.1个月（95% CI，12.1 - 15.8），12个月OS概率为87.6%（95% CI，79.1 - 92.8%）。在接受贝伐单抗-awwb治疗期间，18例初治患者（14.0%）报告了20起关注事件（EOIs），4例转换者报告了4起EOIs（3.8%），其中最常报告的事件是血栓栓塞和出血事件。大多数EOIs导致急诊就诊和/或治疗中断/停药/换药。没有EOIs导致死亡。
在这个使用贝伐单抗生物相似药（贝伐单抗-awwb）进行1L治疗的mCRC患者真实世界队列中，临床有效性和耐受性数据符合预期，且与先前发表的关于mCRC患者使用贝伐单抗参比产品的真实世界研究结果一致。
