Results of a study evaluating a novel biomarker approach for immunotherapy were presented during a poster presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place virtually from June 4-8, 2021.

The study paired a comprehensive genomic and transcriptomic profiling (CGTP) assay, developed by Strata Oncology, with real-world clinical data to predict the therapeutic benefits of pembrolizumab (Keytruda®; Merck & Co) in patients with advanced solid tumors.

ASCOThe study found that PD-L1, PD-L2, and tumor mutation burden (TMB) from the CGTP test independently predicted therapeutic benefits of pembrolizumab in pan-solid tumors. Furthermore, when combined in a multivariate signature score, the study found benefits 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 Oncology®, clinical-molecular database, and real-world data, also predicted the therapeutic benefit of pembrolizumab relative to chemotherapy across solid tumors.

The study results included data from 610 patients (254 [41.6%] NSCLC; 356 [58.4%] from 23 other ST types) with CGTP and P treatment) with advanced solid tumors with TMB and immune gene expression data from the Strata Oncology CGTP tissue test and documented pembrolizumab treatment outcomes.

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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,” noted Scott Tomlins, MD, Ph.D., 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.”

Clinical trials
Assessing the Clinical Benefit of Molecular Profiling in Patients With Solid Tumors – NCT03061305

Highlights of prescribing information
Pembrolizumab (Keytruda®; Merck & Co) [Perscription Information]

[1] Dan Rhodes, Daniel H Hovelson, Malek M. Safa, Mark E. Burkard, Eddy Shih-Hsin Yang, William Jeffery Edenfield, Travis Reeder, et al. Comprehensive genomic and transcriptomic profiling (CGTP) to predict pembrolizumab (P) benefit in patients (pts) with advanced solid tumors (STs). Abstract: 2609; Presented at: American Society of Clinical Oncology (ASCO), held June 4 – 8, 2021. J Clin Oncol 39, 2021 (suppl 15; abstr 2609)

Featured image: The annual ASCO meeting before the COVID-19 pandemic. General view of the 55th Annual Meeting of the American Society of Oncology (ASCO). Courtesy: © 2019 ASCO/Kristen Norman. Used with permission.

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