The Piedmont Study, a Real-World Data Analysis in Patients Treated with Platinum Doublet Chemotherapy and/or Pembrolizumab, Identifies Predictive Biomarkers for Approved First-Line Treatments in NSCLC

DURHAM, N.C.–(BUSINESS WIRE)– GeneCentric Therapeutics, a company making precision medicine more precise through RNA-based diagnostics, announced today the completion of its Piedmont Study, conducted in collaboration with Atrium Health Levine Cancer Institute.

Early results suggest that GeneCentric’s Antifolate Predictive Response Signature (AF-PRS), one of the signatures included in the recently announced strategic collaboration with Labcorp, identified a distinct population of patients who clearly benefit from treatment with pemetrexed/platinum doublet chemotherapy. Leveraging this deeper understanding with RNA-based tests such as the AF-PRS may help identify a broader patient population that may benefit from therapy, compared to DNA mutation analysis.

“We founded GeneCentric over a decade ago to study the genomics of lung cancer using the deep insights that can be obtained through gene expression analysis,” said Neil Hayes, M.D., GeneCentric co-founder and Director of the University of Tennessee Health Science Center for Cancer Research. “While our work has expanded well beyond the lung, the actionable clinical and genomic datasets we have developed have led to multiple signatures and related prototype tests. As a treating physician, I am excited about the promise of the predictive insights that can be gained from the Piedmont Study as we navigate the existing and emerging treatment options for lung cancer patients.”

In this retrospective study of real-world data, clinical response data and existing tumor samples were collected from about 250 patients with non-squamous non-small cell lung cancer (NSCLC) who were treated with either pemetrexed/platinum doublet chemotherapy, pembrolizumab (Keytruda®), or the combination of the two. The Piedmont Study paired highly curated real-world clinical and demographic data with bulk tumor RNA transcriptome analysis from patients with NSCLC, which was analyzed using GeneCentric’s RNA-based Tumor and Immune Micro-Environment (rT(I)ME) Explorer platform.

“There has been great progress with the development of new treatment options for patients with locally advanced or metastatic non-small cell lung cancer,” said Kathryn Mileham, M.D., Piedmont Study Principal Investigator and Chief of the Section of Thoracic Medical Oncology at Atrium Health Levine Cancer Institute. “With the prevalent use of immune oncology agents alone or in combination with chemotherapy, there needs to be a deeper understanding of how to select the right treatment for the right patient, and the Piedmont Study will aid in this endeavor.”

The clinical and genomic data analysis from this study is ongoing. The AF-PRS test and associated lung adenocarcinoma (LUAD) molecular subtype classifier assay explored in the current study will support GeneCentric’s growing pipeline of novel RNA-based predictive response signatures and related tests. In addition, this real-world evidence dataset joins the expanding number of highly curated clinicogenomic datasets across multiple tumor types and therapeutics areas that GeneCentric has developed and deployed, in collaboration with pharmaceutical and biotechnology partners, to explore novel oncology therapeutic options and diagnostic tests.

About the Piedmont Study

Utilizing Atrium Health Levine Cancer Institute’s broad network of 25+ clinical centers that see around 20,000 new cancer cases per year, retrospective baseline clinical, demographic and clinical response data were collected on over 500 patients receiving systemic first-line treatment for locally advanced or metastatic non-squamous NSCLC. The primary focus of the study was a subset of approximately 250 patients with existing tumor samples who received either pemetrexed-containing platinum doublet chemotherapy, pembrolizumab (Keytruda®) or the combination of the two. Tumor samples underwent transcriptome RNA sequencing (RNAseq) and were analyzed using GeneCentric’s RNA-based Tumor and Immune Micro-Environment (rT(I)ME) Explorer platform, which is an integrated pipeline used to translate tumor biology insights into actionable genomic signatures predictive of drug response.

About GeneCentric

GeneCentric Therapeutics, Inc. is an RNA-based genomic solutions provider based in Durham, North Carolina. The company designed its technologies to parse the complexity of tumor and immune biology using its RNA-based Tumor and Immune Micro-Environment (rT(I)ME) Explorer platform to discover and develop signatures of responder populations to oncology therapeutics. GeneCentric commercializes its technology through strategic collaborations with pharmaceutical, biotechnology and diagnostics companies in applications throughout preclinical testing, clinical drug development and commercialization lifecycle phases. For more information, visit www.genecentric.com or follow us on LinkedIn.

Contacts
Robin Fastenau
pr@genecentric.com