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Jirawas Sornkom
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P37 - Pathology - Biomarker Testing (ID 107)
- Event: WCLC 2020
- Type: Posters
- Track: Pathology, Molecular Pathology and Diagnostic Biomarkers
- Presentations: 1
- Moderators:
- Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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P37.33 - A look at EGFR, ALK, and PD-L1 Biomarker Test Availability, Adoption, and Test Ordering Behavior at Diagnosis of NSCLC in the United States (ID 3522)
00:00 - 00:00 | Presenting Author(s): Jirawas Sornkom
- Abstract
Introduction
Over the last decade, multiple therapies have become available providing effective, actionable treatment options for Non–Small Cell Lung Cancer (NSCLC) patients targeting biomarkers such as ALK, EGFR, and PD-L1. This has brought the promise of Precision Medicine to NSCLC patients where treatment of NSCLC continues to be more biomarker-driven with increasing targeted therapies available to patients testing positive for various biomarkers. We assessed the US testing landscape and testing behaviors for EGFR, ALK, and PD-L1 (NCCN category 1 NSCLC biomarkers) at diagnosis to uncover trends in biomarker testing.
Methods
The US NSCLC testing landscape for EGFR, ALK, and PD-L1 was assessed utilizing our proprietary Global Diagnostic Index (GDI). Real-world data from 66,725 NSCLC patients from Q1 2019-Q1 2020 and profiling of 275 molecular and 1,712 IHC testing labs for NSCLC were used to evaluate test availability, and adoption and test ordering behavior. Data for 14,550 advanced/metastatic NSCLC patients were used to assess testing rates from Q3 2017-Q1 2020.
Results
Testing for EGFR, ALK, and PD-L1 is offered by 153, 143, and 59 labs, respectively. Further, EGFR and ALK, which have a longer history of testing, are relatively decentralized with 56% and 52% of NSCLC labs performing testing in-house, respectively. PD-L1 testing is relatively centralized, with only 3% of labs performing IHC on NSCLC samples offering in-house PD-L1 testing. As of Q1 2020, testing rates for ALK, EGFR, and PD-L1 were 73%, 78%, and 81%, respectively. While testing rates for these 3 biomarkers have stabilized since Q4 2017, adoption time for PD-L1 was shorter (2 years vs 6+ years).
53% of NSCLC patients were tested for all 3 biomarkers, of which 81% were tested simultaneously. In 14% of cases where 3 biomarkers were tested, 2 were tested simultaneously at diagnosis followed by the 3rd at a later point in the patient journey, primarily represented by EGFR and PD-L1 followed by ALK (13%). Conversely, 4% of patients were tested for one biomarker first followed by two biomarkers later, where PD-L1 was performed initially followed by EGFR and ALK (3%). Fully sequential testing with 3 biomarkers constituted 1% of NSCLC patients. 10% of patients were tested for any 2 of the 3 biomarkers, with 85% tested in parallel; at diagnosis, EGFR was included in 84% of tests, PD-L1 in 61% of tests, and ALK in 40% of tests. Patients received a single biomarker test 37% of the time, where PD-L1, EGFR, and ALK were tested 91%, 6%, and 3% of the time, respectively.
Conclusion
Biomarker testing availability and adoption is not immediate once clinical utility is established, suggesting a lack of awareness regarding therapies and associated biomarker tests exists among key stakeholders in patient treatment.
Although NCCN guidelines recommend simultaneous testing of EGFR, ALK, and PD-L1 at diagnosis, actual testing behaviors reveal that this is not always the case. Several factors, such as sample availability, expected biomarker positivity rates, turnaround time, and cost, may affect which biomarkers are tested and when, leading to eligible patients missing an effective treatment option.
