TEST:

StrataNGS™ Test

Using our previously validated HER2 threshold, among 75 eligible SCMD breast cancer patients treated with 1st or 2nd line systemic trastuzumab or pertuzumab containing therapy, HER2 RNA High patients (n=46, 59%) had significantly longer time to next therapy (TTNT) compared to HER2 RNA Not High patients (median TTNT 26.9 vs. 5.6 months, adjusted hazard ratio 0.31, p=0.005 when adjusted for 1st vs. 2nd line, pertuzumab inclusion, and inclusion of chemotherapy or hormonal therapy).In patients with available IHC data (n = 388), HER2 RNA expression trended with IHC across the 0-3+ range, however, while 3+ tumors had distinctly high RNA expression (median: 14.4), 0-2+ tumors had lower expression with overlapping distributions (median: 10.5, 10.9, 11.5, respectively), suggesting that 0-2+ tumors do not represent distinct biological groups, but rather a continuum of low expression. Additionally, 25.8% of all non-breast solid tumors were classified as HER2 RNA Low. Given that HER2 RNA High predicted benefit from 1st generation anti-HER2 therapies, future studies should consider HER2 RNA Low as an alternative biomarker to Her2 IHC Low, with the opportunity to further expand trastuzumab deruxtecan use into the IHC 0+ breast cancer population and potentially to additional solid tumors.

Across a large consecutive CGP cohort, the rates of significant TC discordance varied by tumor type and TSA, among other factors. Samples with TSA ≤5mm2 (41.4% of StrataNGS CGP tested samples) are especially susceptible to TC discordance; therefore, histopathology should not be used solely to determine TC in minute tumor samples.

"Strata Oncology, Inc...announced the integration of discrete genomic data from its StrataNGS® next-generation sequencing-based tumor profiling with the University of Wisconsin Carbone Cancer Center and UW Health Epic genomics module....The integration will streamline workflows for physicians by creating an easily-accessible and user-friendly database, allowing them to more quickly identify the optimal therapy for each patient with cancer. This integration will also enable the institution to expand its research and understanding of cancer."

P=N/A; Most real-world tissue samples from patients with advanced cancer desiring CGP are limited, requiring optimized CGP approaches to produce meaningful results. An optimized PCR-CGP test, coupled with an inclusive exception testing policy, delivered reportable results for > 94% of samples, potentially expanding the proportion of CGP-testable patients and impact of biomarker-guided therapies.

CGTP in an observational trial cohort demonstrated that TMB, PD-L1 and PD-L2 independently predicted pan-ST P benefit as assessed by OS-validated TTNT . A multivariate CGTP signature predicted P benefit relative to C across ST types . If further validated, such a signature may enable improved P benefit prediction .

Our data suggest that different TP53 GOF mutations are associated with very different clinical outcomes . Additional studies identifying specific TP53 GOF mutations that impact outcomes may provide further insight for drug development and clinical trial design.

This allowed for more precise, targeted therapies with higher efficacy, clinical trial matching, and lower risks of side effects. With precision medicine rapidly expanding, oncology nurses must be well versed in the concepts and implications of NGS to individualize treatments and provide patient education.