Strata Oncology, Inc., a precision oncology company advancing molecular indications for cancer therapies, today announced the results of a study focused on evaluating a novel biomarker approach for immunotherapy, utilizing its comprehensive genomic and transcriptomic profiling (CGTP) assay paired with real-world clinical data to predict pembrolizumab benefit in patients with advanced solid tumors. The data were shared during a poster presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place virtually from June 4-8, 2021.

The study found that PD-L1, PD-L2 and tumor mutation burden (TMB) from the CGTP test independently predicted pembrolizumab benefit in pan-solid tumors – and when combined in a multivariate signature score – predicted benefit better than PD-L1 or TMB alone. Across a dataset of over 20,000 advanced solid tumors, the Strata immune response score identified 12% of all patients across a range of solid tumor types that are outside of currently approved indications but predicted to benefit from immunotherapy.  The multivariate signature, developed from the Strata clinical-molecular database and real-world data, also predicted pembrolizumab benefit relative to chemotherapy across solid tumors. 

The study included 610 patients with advanced solid tumors with TMB and immune gene expression data from the Strata Oncology CGTP tissue test and documented pembrolizumab treatment outcomes. Pembrolizumab treatment benefit was assessed by time to next treatment (TTNT), which was validated against overall survival. Real-world TTNT was defined as time in months from therapy start to new treatment or death.  

“Immune checkpoint inhibitors are approved in many solid tumor types, but current biomarkers for predicting response are imperfect,” said Scott Tomlins, MD, PhD, Chief Medical Officer at Strata Oncology. “Currently a minority (20-30%) of patients are estimated to respond to PD-1/PD-L1 therapy so the development of biomarkers for predicting the efficacy of immune checkpoint inhibitors is urgent. Strata’s multivariate biomarker, derived from our genomic and transcriptomic profiling assay, may expand the pan-tumor treatable population beyond current biomarkers.”

The full poster can be viewed at www.asco.org. 

Poster details

• Title: Comprehensive genomic and transcriptomic profiling (CGTP) to predict pembrolizumab benefit in patients with advanced solid tumors 
• Session: Developmental therapeutics – immunotherapy
• Subtrack: Tissue-based biomarkers
• Abstract #: 2609