Aim: Evaluated real world use of bevacizumab-awwb (MVASI®), a bevacizumab biosimilar, for treating metastatic colorectal cancer (mCRC). Materials & methods: Adult mCRC patients who received bevacizumab-awwb during the first year after market availability were identified from the ConcertAI oncology dataset. Results: Of 304 patients, 47% initiated bevacizumab-awwb as reference product (RP) naive patients and 53% received bevacizumab-awwb with prior exposure to RP. Overall, 78% received bevacizumab-awwb as first-line therapy; the proportion was higher (91%) in RP-naive patients. Among RP-experienced patients, 83% were transitioned from RP to bevacizumab-awwb in the same line without disease progression; of those, the majority (83%) were transitioned within 28 days. Conclusion: Early evidence from US oncology practices suggests clinical adoption of bevacizumab-awwb in treating mCRC patients.

e15581 Background: Bevacizumab-awwb (MVASI) was the first FDA-approved biosimilar to Avastin (reference product, RP). Real-world data on effectiveness and safety remain limited and may help address barriers to utilization. Methods: Adult patients who had a confirmed diagnosis of metastatic colorectal cancer (mCRC) (initial presentation on or after 1 January 2018) and initiated bevacizumab-awwb between 19 July 2019 and 30 April 2020 were identified in the ConcertAI Definitive Oncology EMR Dataset. A retrospective medical chart review was conducted to evaluate patient clinical characteristics and outcome data. The current analysis focused on the subset of patients who initiated first-line (1L) bevacizumab-awwb containing therapy (with no prior use of RP) to evaluate incidence of events of interest (EOIs) (Table) and overall survival (OS) probability using Kaplan-Meier analysis. Patients were followed from the initiation of 1L therapy until death, end of record, or end of study period (June 2021), whichever occurred first. Results: A total of 129 patients who initiated bevacizumab-awwb as 1L treatment in combination with chemotherapy were included in this analysis. Majority of patients (78.3%) were treated at clinical oncology practices in a community setting (median age: 60.5 years, 53.5% male). 34.9% of patients had non-metastatic disease (stage of I/II/III) at the initial diagnosis and 38.8% had undergone surgical resection. Median duration of available follow-up data was 10.7 (range: 0.69-22.4) months. During the study period, 100 out of 129 patients had disease progression of which 46 patients had a record of death. The Kaplan-Meier analysis showed that 12-month OS probability was 71.4% (95% CI: 61.0%-79.5%). During treatment with bevacizumab-awwb, 20 EOIs were reported in 18 patients (14.0%). Distribution of events and their management are presented in the Table. None of these EOIs resulted in death. Conclusions: Biosimilar bevacizumab-awwb appeared to be well tolerated, with observed EOIs being manageable, and 12-month OS probability of > 70% for treating patients with mCRC in the real-world setting.[Table: see text]

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.

Background: In July 2019, bevacizumab-awwb and trastuzumab-anns were marketed in the USA as the first therapeutic oncology biosimilars. We aimed to investigate the initial real-world use of bevacizumab-awwb and trastuzumab-anns for cancer management in US oncology practices. Methods: A retrospective, observational analysis of data from US cancer patients (⩾18 years of age) was carried out to describe the use of bevacizumab-awwb and trastuzumab-anns during the first 12 months following their market entry, using structured data from the Flatiron Health electronic health record-derived database. Results: A total of 2952 and 2997 patients with recorded use of bevacizumab-awwb and trastuzumab-anns, respectively, were included in the analysis. The first use of bevacizumab-awwb and trastuzumab-anns was in a patient with metastatic colorectal cancer (mCRC) within 10 days of market availability and in a patient with early stage breast cancer (eBC) within 4 days, respectively. The use of these biosimilars was observed across all approved cancer indications; 68% of bevacizumab-awwb users were those diagnosed with mCRC and 72% of trastuzumab-anns users were those diagnosed with eBC. Approximately half the patients were previously exposed to reference product (RP) prior to initiation of bevacizumab-awwb or trastuzumab-anns. Among pre-exposed patients, the majority received the biosimilars [bevacizumab-awwb (63–85%) or trastuzumab-anns (75–81%)] within 28 days of the last infusion of the RP. For both biosimilars, no major differences were observed in patient characteristics between RP-naïve and pre-exposed patients. Conclusion: Initial evidence from the first 12 months following market entry suggests rapid clinical adoption of bevacizumab-awwb and trastuzumab-anns across all approved tumor types. Usage of these two biosimilars was observed in both RP-naïve patients and patients who were previously treated with RP, with no distinctive differences in patient characteristics between the two groups. A video abstract is available for this article as part of the Kanjintionline supplemental material.

The WPAI-UC is a self-administered six-item survey that generates four metrics: absenteeism (work time missed), presenteeism (impairment whilst working), productivity loss (overall work impairment from the combination of absenteeism and presenteeism), and activity impairment (non-work activity impairment). WPAI component scores are expressed as percentages, with a higher percentage indicating greater impairment and less productivity The IBDQ evaluates disease-related quality of life by 32 items over four domains: bowel (total domain score ranges from 10 to 70), emotional (total domain score ranges from 12 to 84), social (total domain score ranges from 5 to 35), and systemic (total domain score ranges from 5 to 35). For the total score (ranges from 32 to 224) and each domain, a higher score indicates a better quality of life CI,