Strata Oncology, Inc. (“Strata”), a next-generation precision oncology company enabling smarter and earlier cancer treatment, today announced that it will present new data in four scientific posters at the American Association for Cancer Research (AACR) Annual Meeting 2023, taking place April 14-19, 2023 in Orlando, Florida.

The data to be presented includes results for innovative, proprietary predictive biomarkers for fam-trastuzumab-deruxtecan-nxki, sacituzumab govitecan and pembrolizumab. Strata has developed these biomarkers and others using data collected through an observational clinical trial protocol called the Strata Trial^® (NCT03061305). All of these biomarkers take advantage of the company’s unique molecular profiling platform that combines DNA and quantitative RNA sequencing on a single small tumor tissue sample. 

“Strata Oncology is leading the way in bringing expression-based therapies, such as antibody-drug conjugates and immunotherapies, into the precision era with highly quantitative RNA and multivariate predictive treatment selection algorithms,” said Scott Tomlins, M.D., Ph.D., Strata Oncology co-founder and chief medical officer. “Data from the Strata Trial is allowing us to identify new biomarker-guided patient populations for therapies already on the market, thus opening up treatment pathways that can drive better outcomes for more people. We look forward to sharing our latest advances at the AACR meeting.”

Poster presentation details: 

Poster Title: 968/19 – Evaluation of Her2 RNA expression as a potential predictive biomarker for anti-Her2 therapy
Track: Biomarkers of Therapeutic Benefit 1
Session Date and Time: Sunday Apr 16, 2023, 1:30 PM – 5:00 PM EDT
Overview: Trastuzumab-deruxtecan is effective in “HER2 Low” (1+ or 2+ expression by immunohistochemistry (IHC)) breast cancer. There is increasing interest in defining a sub-population of IHC 0+ tumors that may have HER2 expression below the limit of IHC detection/quantification and may thus also be responsive. Using data from its high dynamic range assay for HER2 expression and clinical outcome data from the Strata Trial, Strata defined a HER2 RNA low threshold based on IHC from breast cancer patients. At this threshold, nearly half of 0+ breast cancers were classified as HER2 RNA Low, as were more than a quarter of non-breast solid tumors, representing tumors that may be responsive to anti-HER2 therapies. HER2 RNA Low has the potential to be an alternative biomarker to Her2 IHC Low, with the opportunity to further expand trastuzumab-deruxtecan use.

Poster Title: 2171 /13 – A multivariate biomarker predicts sacituzumab govitecan response in solid tumors
Track: Biomarkers of Therapeutic Benefit 3
Session Date and Time: Monday Apr 17, 2023, 9:00 AM – 12:30 PM EDT
Overview: Despite the recent clinical success of antibody drug conjugates (ADCs), such as the TROP2-targeted ADC sacituzumab govitecan (SG), predictive biomarkers for these therapies are lacking. Leveraging DNA and RNA sequencing data and clinical outcomes data from the Strata Trial, Strata developed a multivariate biomarker algorithm, which combines TROP2 and proliferation by gene expression with tumor cellularity, that produced biomarker positive rates correlating with the objective response rates observed for SG in the IMMU-12-01 basket trial. The multivariate biomarker accounts for 67% of the variability observed in SG response rates and may thus identify patients likely to benefit from SG. Interestingly, most tumor types had biomarker positive rates >5%, suggesting the potential for a tumor type-agnostic approach to patient selection. The biomarker has the potential to improve the selection of patients who are more likely to benefit from SG and may be generalizable to other ADCs.

Poster Title: CT059 / 17 – StrataPATH^TM: a multicohort, non-randomized, open-label phase 2 trial to explore efficacy and safety of FDA-approved cancer therapies in novel biomarker-guided patient population
Track: Phase II and Phase III Clinical Trials in Progress
Session Date and Time: Monday Apr 17, 2023, 9:00 AM – 12:30 PM EDT
Overview: The Strata Precision Indications for Approved Therapies (Strata PATH^TM; NCT05097599) trial is a non-randomized open-label, prospective pan-tumor therapeutic trial designed to evaluate the efficacy and safety of multiple FDA-approved cancer therapies in new, biomarker-guided patient populations. Enrollment into a cohort of this basket trial is based on novel biomarkers including DNA, quantitative RNA expression and novel multivariate algorithms that account for both tumor and tumor microenvironment variables hypothesized to predict improved therapeutic response. The therapeutic classes evaluated in Strata PATH include targeted therapies, antibody-drug conjugates, immunotherapies, and angiogenesis inhibitors. Strata PATH provides the next important step forward in precision medicine, guiding clinical trial and therapy selection by expanding biomarker testing to quantifiable RNA expression and multivariant algorithm based molecular testing.

Poster Title: 4348 / 23 – Validation of an integrative pan-solid tumor predictor of pembrolizumab monotherapy benefit
Track: Biomarkers of Therapeutic Benefit 4
Session Date and Time: Tuesday Apr 18, 2023, 9:00 AM – 12:30 PM EDT
Overview: Strata previously reported the development and validation of an integrative Immunotherapy Response Score (IRS) algorithm, which integrates tumor mutation burden (TMB) and quantitative gene expression of tumor and tumor microenvironment biomarkers to predict anti-PD-1 or PD-L1 (together anti-PD-[L]1) monotherapy benefit across solid tumors from routine formalin fixed paraffin embedded samples. Strata has now evaluated IRS performance for predicting immunotherapy benefit in a second, independent validation cohort of patients treated with pembrolizumab monotherapy. As seen before, pembrolizumab monotherapy real-world progression-free survival (rwPFS) was significantly longer in IRS-high vs. IRS-low patients. In a case cross-over analysis of patients treated with systemic therapy prior to pembrolizumab monotherapy, pembrolizumab rwPFS was significantly longer than preceding therapy in IRS-high patients but not IRS-low patients. These results confirm the pan-solid tumor PD-(L)1 monotherapy predictive nature of the IRS biomarker.