Strata Oncology (“Strata”), a leader in the discovery and development of biomarkers for targeted cancer therapies, today announced the successful completion of an independent evaluation of its proprietary multifactorial biomarker for Antibody Drug Conjugates (ADCs) using a validated clinical trial assay (CTA). The evaluation, completed in collaboration with a third party health system, demonstrated positive results across the primary endpoint of Response Rate (RR), as well as Progression-Free Survival (PFS), and Overall Survival (OS), resulting in  the first biomarker validated to predict ADC benefit across multiple ADC targets, ADC payload classes, and tumor types. 

The data will be presented at the 2025 American Association for Cancer Research (AACR) Annual Meeting, in Chicago on Monday, April 28, 2025 from 9:00 AM to 12:00 PM EDT in the Predictive Biomarkers 3 poster session (PO.CL01.08).

Key Findings: 

• The biomarker meaningfully and statistically identified patients more likely to respond to ADC therapy, with biomarker-high patients living twice as long as biomarker-low patients.
• The positive results were observed across multiple ADCs (and payloads) and tumor types, highlighting the biomarker’s broad applicability and potential in enhancing treatment outcomes.
• The biomarker’s association with improved clinical outcomes, including significant stratification of Response Rate (RR), Progression-Free Survival (PFS), and Overall Survival (OS), supports its role as a predictive tool for the development and selection of ADC therapy.

“We are thrilled with the results of this independent evaluation, which validates the strength of our biomarker and its ability to predict the efficacy of ADC therapies across a variety of tumor types,” said Dan Rhodes, CEO of Strata. “These findings provide strong evidence that our biomarker could play a pivotal role in improving clinical outcomes for patients, with the potential to identify more patients who could benefit from ADC therapies and derisking development of new drug candidates. We look forward to advancing this biomarker toward broader clinical applications in the ADC space.”