Abstract 94P
Background
In current practice, determining patients’ eligibility for a clinical study is typically ‘study-orientated’. Frequently, however, a candidate patient is ineligible due to a negative result of the (companion) biomarker test. Often, there is insufficient time or tissue available to reconsider and test for an alternative study. The increase in biomarker-driven trials, together with the availability of clinical-grade comprehensive testing, warrants for a more comprehensive screening strategy by which all study options are elucidated simultaneously. Here we investigated the yield for biomarker presence and potential study eligibility when using Whole Genome Sequencing (WGS) as a diagnostic test.
Methods
Biomarker details for recruiting clinical studies for solid tumors in the Netherlands were collected using the JAX Clinical Knowledge Base and the iClusion Trial-eye database. WGS and associated clinical data of 7,432 patients with metastatic cancer was obtained from the Hartwig Database (accessed 23-nov-‘23). Biomarker matching was performed based on mutated driver gene association (excluding passenger events), aberration type, and considering tumor type-specific criteria.
Results
At the time of analysis 131 actively recruiting biomarker-based clinical studies were identified. In total, 73 different genes were identified as study biomarker inclusion criteria and an additional 14 studies (also) used mutation profiles as inclusion marker: MSI (n=12), TMB (n=2), and HRD (n=3). The average study eligibility yield considering all patients and matched for tumor-type and biomarker criteria was 14% (median 8%, range 0-58%). The tumor agnostic studies (n=32, 24% of total) had an average eligibility rate of 7%. When considering eligibility from a patient perspective, at least one of the 36 biomarkers from these tumor type-agnostic studies could be identified as driver event in 72% of the patients.
Conclusions
WGS-based comprehensive screening of cancer patients, which tests all possible DNA-based biomarkers in parallel, is expected to increase identification of patients that can participate in (biomarker-driven) clinical studies, especially regarding tumor type-agnostic drugs.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.