Initial experience of patients treated in a real-world clinical setting with bevacizumab-awwb: The first FDA-approved biosimilar to bevacizumab.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 81-81
Author(s):  
Ran Jin ◽  
Neil A Accortt ◽  
Darcie Sandschafer ◽  
Tatiana Lawrence ◽  
Arturo Loaiza-Bonilla
Keyword(s):  
Real World ◽  
Clinical Characteristics ◽  
Reference Product ◽  
Previous Treatment ◽  
The United States ◽  
Product Launch ◽  
Cancer Management ◽  
Level Data ◽  
Nsclc Patients ◽  
Tumor Types

81 Background: Bevacizumab-awwb is the first anti-cancer biosimilar and the first biosimilar to bevacizumab approved by the FDA. It was launched in the United States on July 19, 2019. Bevacizumab-awwb approval was based on a phase 3 study in a pre-determined sensitive population of non-squamous non-small cell lung cancer (NSCLC) patients. This study investigated initial use of bevacizumab-awwb, across its approved indications for advanced cancer management, in real-world US community and academic oncology practices. Methods: This retrospective observational study described demographic and clinical characteristics of patients who received bevacizumab-awwb using structured patient-level data from the nationwide de-identified Oncology Services Comprehensive Electronic Records (OSCER), a Flatiron Health EHR-derived database. The database is longitudinal, demographically and geographically diverse, and includes more than 2.2 million US cancer patients from >280 cancer clinics. This analysis included adult patients who received ≥1 bevacizumab-awwb infusion between July 30, 2019 and April 30, 2020 and focused on describing initial biosimilar uptake in cancer patient populations beyond NSCLC. Results: First use of bevacizumab-awwb was in mCRC and occurred within 10 days of product launch. All bevacizumab-awwb approved cancer indications were represented among 2,422 patients treated with bevacizumab-awwb. Initial use of bevacizumab-awwb across indications: mCRC (68%), NSCLC (14%), brain cancer (11%), cervical cancer (5%), metastatic renal cell carcinoma (1%). Among 1657 mCRC patients treated with bevacizumab-awwb, 55% were male with a median age of 65 years (y). Most patients were white (60%), with ECOG scores of 0/1 (84%), and median body weight was 78 kg. Among mCRC patients, 59% had received the reference product before receiving the biosimilar. Among patients with other tumor types, 42-50% had prior bevacizumab exposure. Among mCRC patients with prior exposure to bevacizumab, 67% received bevacizumab-awwb within 28 days of last infusion of reference product (Table). Demographic and clinical characteristics were comparable between patients with and without prior bevacizumab use. Conclusions: Early evidence suggests physicians are comfortable initiating or transitioning patients to the first FDA-approved biosimilar to bevacizumab, with little evidence that demographic characteristics differ between patients with and without previous treatment with bevacizumab. Future analyses will determine whether these patterns persist across all indications. [Table: see text]

Analysis of real-world PD-L1 IHC testing for clinical use in patients across multiple tumor types.

2019 ◽  
Vol 37 (8_suppl) ◽  
pp. 151-151
Author(s):  
Gabriel S Krigsfeld ◽  
Emily Prince ◽  
Kim Zerba ◽  
Vladislav Chizhevsky ◽  
Josette William Ragheb ◽  
...  
Keyword(s):  
Real World ◽  
Clinical Characteristics ◽  
Analytical Data ◽  
Fold Increase ◽  
The United States ◽  
Reference Laboratory ◽  
Tumor Cell Membrane ◽  
Multiple Tumor ◽  
Programmed Death ◽  
Tumor Types

151 Background: A number of programmed death ligand 1 (PD-L1) IHC diagnostic tests have been approved by the FDA to guide treatment with programmed death-1/PD-L1 inhibitors. We evaluated PD-L1 assay utilization and concordance across all tumor types, including melanoma (MEL) and squamous cell carcinoma of the head and neck (SCCHN), using real-world cancer samples tested at a single reference laboratory in the United States. Methods: 55,652 samples with clinical characteristics were provided by Symphony Health Solutions. NeoGenomics Laboratories, Inc assessed PD-L1 expression using the Dako PD-L1 IHC 28-8 or 22C3 pharmDx, or Ventana PD-L1 SP142 assay tests between October 2015 and April 2018, according to the manufacturers’ protocols at the time of the study. Clinical characteristics were matched to PD-L1 test results using unique identifiers. Data were analyzed by BioStat Solutions, Inc. Results: 61,568 tests from 55,652 patients were included. Across all 61,568 tests, 88.8% were carried out with 22C3, 9.8% with 28-8, and 1.4% with SP142. The 28-8 and 22C3 pharmDx assays showed high analytical concordance in all 3113 matched samples with PD-L1 expression data for both assays (OPA = 96.2%, Spearman’s r = 0.96; Table). The failure rate across all tests was 3.5%, and 96.6% of patients had a quantifiable test result. Average test turnaround time was 3.1 days, with a 9.1-fold increase in total number of tests performed between Q4 2015 and Q1 2018 (from 1163 to 10,544). Subgroup analyses for 678 patients (1.2%) with MEL and 270 patients (0.5%) with SCCHN will be presented. Conclusions: Despite an increased demand for PD-L1 testing in the US, most patients received a result in 2–4 days. These real-world analytical data support the potential interchangeability of the Dako PD-L1 IHC 28-8 and 22C3 pharmDx assays in clinical practice for assessing tumor cell membrane PD-L1 expression across tumor types, and provide context on the evolution and adoption of PD-L1 testing for patients with cancer. [Table: see text]

Demographics and clinical characteristics of metastatic colorectal cancer patients treated with bevacizumab-awwb in real-world oncology clinics.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 90-90
Author(s):  
Richard DeClue ◽  
Whitney Rhodes ◽  
Neil A Accortt ◽  
Ran Jin ◽  
Darcie Sandschafer ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Real World ◽  
Clinical Characteristics ◽  
Community Setting ◽  
Clinical Trial Data ◽  
The United States ◽  
Product Launch ◽  
Chronic Obstructive ◽  
Primary Tumors

90 Background: Bevacizumab-awwb is a biosimilar to bevacizumab approved by the FDA based on evidence obtained in a phase 3 study in non-squamous non-small cell lung cancer. The present real-world evidence study evaluated experience with bevacizumab-awwb (launched 07/19/2019) in patients with metastatic colorectal cancer (mCRC) in a real-world oncology setting to gain insight into biosimilar use for a bevacizumab-awwb approved indication lacking clinical trial data. Methods: This retrospective analysis identified patients, age ≥ 18 years (y), within existing medical records diagnosed with mCRC who initiated bevacizumab-awwb as first- or later-line treatment. Patients were identified from the ConcertAI Definitive Oncology Dataset, a consolidated EMR database of CancerLinQ and Vector Oncology, representing geographically diverse practice locations, including rural and urban centers, within the United States. Results: A total of 304 patients were eligible for this analysis. First use of bevacizumab-awwb in mCRC occurred within 20 days of product launch. Most patients (n = 262, 86%) were treated in a community setting and more than half of all eligible patients received prior bevacizumab (n = 162, 53%). Among 42 patients treated in academic settings 29 (69%) had not received bevacizumab prior to receiving bevacizumab-awwb. In the 162 patients with prior bevacizumab use, 134 (83%) had no recorded disease progression between the last bevacizumab infusion and start of bevacizumab-awwb. Among these 134 patients, 111 (83%) received bevacizumab-awwb within 28 days of last bevacizumab dose. Demographic and clinical characteristics of patients stratified by prior bevacizumab use were comparable (Table). In both subgroups most patients had an adenocarcinoma histological diagnosis with primary tumors in the rectum or sigmoid colon. Overall, most frequent comorbidities of mCRC patients were diabetes (24%), chronic obstructive pulmonary disease (10%), and renal disease (8%). Conclusions: Patients with mCRC who received bevacizumab-awwb in this real-world oncology setting in the first year post product launch were similar regardless of prior bevacizumab use. Among patients with prior bevacizumab use, 83% continued with bevacizumab-awwb in the same line. In the subset of patients without progression post bevacizumab, most received bevacizumab-awwb within 28 days of last bevacizumab dose demonstrating use of bevacizumab-awwb in new and continuing patients. [Table: see text]

Real-world trends in biosimilar prescribing among oncology providers, 2019-2021.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18701-e18701
Author(s):  
Kelly A. McGlynn ◽  
Jacqueline McGarry ◽  
Kashyap B. Patel ◽  
Natasha Clinton
Keyword(s):  
Real World ◽  
Reference Product ◽  
The United States ◽  
Prescription Data ◽  
Nccn Guidelines ◽  
Prescribing Behavior ◽  
Product Pricing ◽  
Value Based Care ◽  
Oncology Providers ◽  
First 90 Days

e18701 Background: The number of approved biosimilars in the United States has increased exponentially in recent years. Within the oncology market, there are currently 14 approved biosimilars, with 11 launched since the start of 2019. The emergence of new oncology biosimilars provides a tool for success in value-based care, and has the potential to lower costs to patients and providers and expand access to care. Methods: Analysis of biosimilar prescribing behavior was performed using 2020 prescription data (Wolters Kluwer, n = 130,836), sales data (IQVIA), and dosage data for patients taking bevacizumab, trastuzumab, rituximab, or an FDA-approved biosimilar for these products (FDA Purple Book), between 2019-2021 (ION Solutions, n = 69,884). Drugs not directly interchangeable with the bevacizumab, trastuzumab or rituximab reference products according to NCCN guidelines were excluded. Results: Biosimilar products are currently available for bevacizumab (2 biosimilars), rituximab (3 biosimilars), and trastuzumab (5 biosimilars). We found that in 2020, 8.2% of new prescriptions for any of these three reference products were for a biosimilar. An analysis of real-world drug administration data revealed that in the 3 months following the 2019 launch of trastuzumab’s first biosimilar (trastuzumab-anns), 7.3% of initiating line 1 patients were prescribed the biosimilar over the reference product. During the same period in 2020, when a total of 5 trastuzumab biosimilars were available, 80.5% of initiating line 1 trastuzumab patients began treatment on a biosimilar, suggesting rapid uptake by providers. However, this differed by product, with the initial uptake for the first rituximab biosimilar (rituximab-pvvr), at only 2.3%. Uptake also occurred within treatment lines, with 11.1% of all patients (bevacizumab: 11.3%, trastuzumab: 14.1%, rituximab: 7.9%) switching from a reference product to a biosimilar during treatment. Uptake was particularly rapid for trastuzumab biosimilars: among patients on trastuzumab at the time of its first biosimilar launch, 18.2% switched to trastuzumab-anns in the first 90 days post-launch. Biosimilars launched at significantly lower prices than their reference products, with cost per prescription at -42.0%, -29.9% and -89.5% relative to the reference product for trastuzumab, rituximab and bevacizumab, respectively. However, biosimilar launches had little impact on reference product pricing, with 2019-2020 year-over-year (YOY) differences in price per prescription close to the YOY averages in previous years (2015-2019) for all three reference products. Conclusions: We conclude that uptake of biosimilars among oncology providers between 2019-2020 was rapid, although the extent of biosimilar prescribing varied among products. Biosimilars offered greatly reduced costs to providers, although reference product prices remained stable despite increased biosimilar competition.

scholarly journals P3.02a-004 NSCLC Patients Harboring ALK Translocation: Clinical Characteristics and Management in Real World Setting. EXPLORE GFPC 02-14

2017 ◽  
Vol 12 (1) ◽  
pp. S1161-S1162
Author(s):  
Isabelle Monnet ◽  
Jean Bernard Auliac ◽  
Radj Gervais ◽  
Anne Marie Chiappa ◽  
Nathalie Baize ◽  
...  
Keyword(s):  
Real World ◽  
Clinical Characteristics ◽  
Real World Setting ◽  
Nsclc Patients

scholarly journals Clinical and treatment characteristics of patients treated with the first therapeutic oncology biosimilars bevacizumab-awwb and trastuzumab-anns in the US

2021 ◽  
Vol 13 ◽  
pp. 175883592110419
Author(s):  
Ran Jin ◽  
Reshma L. Mahtani ◽  
Neil Accortt ◽  
Tatiana Lawrence ◽  
Darcie Sandschafer ◽  
...  
Keyword(s):  
Market Entry ◽  
Reference Product ◽  
Early Stage ◽  
Patient Characteristics ◽  
Cancer Management ◽  
The Us ◽  
The Usa ◽  
Previously Treated ◽  
Tumor Types ◽  
Video Abstract

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.

scholarly journals P3.02b-127 NSCLC Patients Harboring HER2 Mutation: Clinical Characteristics and Management in Real World Setting. EXPLORE GFPC 02-14

2017 ◽  
Vol 12 (1) ◽  
pp. S1271
Author(s):  
Jean Bernard Auliac ◽  
Pascal Do ◽  
Sophie Bayle ◽  
Helene Doubre ◽  
Florent Vinas ◽  
...  
Keyword(s):  
Real World ◽  
Clinical Characteristics ◽  
Real World Setting ◽  
Her2 Mutation ◽  
Nsclc Patients

Does order matter? Real-world data on outcomes of successive regimens involving anti-PDx-1 in advanced and metastatic non-small cell lung cancer.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e21159-e21159
Author(s):  
David Hadley ◽  
Shady Gendy
Keyword(s):  
Real World ◽  
Proportional Hazards ◽  
The United States ◽  
Driver Mutations ◽  
Cancer Center ◽  
Real World Data ◽  
Treatment Protocols ◽  
World Data ◽  
Nsclc Patients ◽  
Platinum Doublet

e21159 Background: In 2020, 65% of newly diagnosed advanced (adv)or metastatic (met) NSCLC patients in US started first line (1L) systemic therapy on anti-PDx-1 regimen, 53% of second line (2L). Between broader approvals of anti-PDx-1, increasing use in different therapy lines, and in different regimen combinations, selecting initial and subsequent regimens can be challenging, especially with limited research on outcomes based on order. This analysis uses real-world data to summarize treatment decisions made in a network of oncology centers and relates them to time to second disease progression (PFS2) and overall survival (OS). PRA US medical & prescription claims – 2020 (Jan-Aug). Methods: Deidentified data on adv/met NSCLC patients were selected from Inteliquet’s Cancer Center Research Consortium partners, which comprises academic & community oncology practices as well as integrated delivery networks across the United States. Analysis was limited to patients who started 1L systemic treatment in 2017 & 2018 (index event), progressed and started 2L. Either 1L / 2L / both must have been anti-PDx-1 based regimen. Patients with known actionable driver mutations were excluded. Data from the following 24 months was used to identify regimens and time to progression. PFS2 and OS across the combined 1L and 2L treatment protocols were assessed by proportional hazards regression. The analysis was adjusted for age at diagnosis, gender, PS and treating organization. Results: 132 patients met the study criteria: 53% were female, the median age range at diagnosis was 60-69 years, and 73% were diagnosed with stage IV, and 76% had PS 0-2 at diagnosis. After 24 months, 86% were alive, all had one progression and 44% had a 2nd progression. The most frequently observed treatment patterns are summarized in the table. Conclusions: Same regimens in different order showed different outcomes. There is a significant benefit for both OS & PFS2 by starting with a platinum doublet followed by IO PT, versus the same start followed by IO MT. There is a significant disadvantage in OS by starting with IO MT followed by platinum doublet, versus the reversed order. 1L IO PT versus baseline showed non-significant improvement in PFS2, but not OS.[Table: see text]

Evaluation of real-world cost savings and utilization of biosimilar drugs in a community-based oncology practice.

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 73-73
Author(s):  
Amit Sanyal ◽  
Michelle Schmitt ◽  
Daniel Wellner
Keyword(s):  
Real World ◽  
Reference Product ◽  
Cost Savings ◽  
The United States ◽  
Biosimilar Product ◽  
Community Based ◽  
Significant Cost ◽  
Clinically Significant ◽  
Oncology Practice ◽  
Practice Methods

73 Background: Biosimilar drugs, defined as biologic products with no clinically significant differences in quality, efficacy and safety compared to approved reference products have gained increasing adoption based on studies projecting significant cost savings[1]. Real world evaluation of biosimilar related cost savings and adoption is however still limited. We prospectively evaluate cost savings generated by transitioning to biosimilar monoclonal antibodies in a community based oncology practice. Methods: In July 2020, a process for transitioning patients to biosimilar equivalents of Rituximab, Trastuzumab and Bevacizumab was implemented in a community based oncology practice. Provider adoption was facilitated by monthly oncology pharmacy governance meetings that allowed provider participation and feedback followed by defaulting the preferred biosimilar product in oncology chemotherapy software (Epic Beacon, Epic Systems, Verona, WI). The treatment templates allowed for care personalization by listing reference products that could be chosen if desired. Cost savings achieved by switching to biosimilars was calculated by subtracting the actual spending on the biosimilar product from projected acquisition cost of the branded reference product (Table). Biosimilar adoption, defined as amount of biosimilar drug used over total amount of the drug ordered was also calculated. Results: Between July 2020 and April 2021, transitioning to biosimilar products for Rituximab, Bevacizumab and Trastuzumab resulted in net savings of $268,194.64, $285,251.89 and $274,359.51 respectively. Actual spending on Rituximab biosimilar product was $726,476.10 against a projected spending of $994,670.74 on the branded reference product. Actual spending on Bevacizumab biosimilar product was $1,254,977.30 against a projected spending of $1,540,229.19 on the branded reference product. Actual spending on Trastuzumab biosimilar product was $1,218,641.60 against a projected spending of $1,493,001.11 on the branded product. Average biosimilar utilization between October 2020 and April 2020 has been 92%, 100% and 98% for Rituximab, Bevacizumab and Trastuzumab respectively. Conclusions: Significant cost-savings can result from widespread utilization of biosimilar drugs in community oncology practices. References: Mulcahy, A.W., J.P. Hlavka, and S.R. Case, Biosimilar Cost Savings in the United States: Initial Experience and Future Potential. Rand Health Q, 2018. 7(4): p. 3.[Table: see text]

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