Strata Oncology, a next-generation precision oncology company enabling smarter and earlier cancer treatment, today announced new data showing its proprietary biomarker algorithm, Immunotherapy Response Score (IRS), supports informed clinical decisions for first-line treatment of patients with non-small cell lung cancer (NSCLC) beyond the standard of care biomarker PD-L1 immunohistochemistry (IHC).

The data from Kaiser Permanente Northern California — the first of its kind for first-line treatment of patients with NSCLC — will be presented at the 2023 World Conference on Lung Cancer in Singapore on Sunday, September 10, 2023 in the Pathology and Biomarkers – Biomarkers for Immuno-Oncology poster session from 5:30 PM to 7:30 PM SGT.

A pre-specified blinded analysis of more than 200 NSCLC patients initially treated with pembrolizumab either alone or in combination with chemotherapy, showed that IRS was significantly associated with time-to-next-treatment (TTNT) independent of therapy type and PD-L1 IHC by tumor proportion score (TPS). Subgroup analysis demonstrated that among patients with PD-L1 High (TPS>=50%), IRS High patients had significantly longer single-agent pembrolizumab TTNT than IRS Low patients, illustrating the opportunity to fill a clear unmet need.

“In NSCLC with PD-L1 TPS>=50%, guidelines recommend either pembrolizumab alone or in combination with chemotherapy. IRS can potentially guide treatment selection in this important and frequent clinical scenario,” said Kat Kwiatkowski, Ph.D., Strata Oncology SVP, Clinical Development. “Given the significant difference between IRS groups, IRS High status would favor treatment with pembrolizumab alone, whereas IRS Low status would favor combination therapy.”

IRS has been validated as a pan-solid tumor predictive biomarker for anti-PD-1/PD-L1 checkpoint inhibitor monotherapy benefit in multiple studies, most recently in a publication in Cancer Research Communications, where the clinical utility of IRS beyond standard biomarkers used to guide anti-PD-1/PD-L1 therapy, including tumor mutation burden (TMB), microsatellite instability (MSI) and PD-L1 IHC was shown. This study also demonstrated the clinical utility of IRS as a useful tool to help guide the choice between chemotherapy alone, anti-PD-1/PD-L1 monotherapy, or anti-PD-1/PD-L1 in combination with chemotherapy, across five tumor types where this is a critical treatment decision. 

“Our Immunotherapy Response Score meets a significant unmet medical need for an integrative diagnostic test that can predict benefit across tumor types, and in this case, specifically help clinicians make informed decisions for first-line treatment of patients with NSCLC,” said Scott Tomlins, M.D., Ph.D., Strata Oncology co-founder and Chief Medical Officer. “This new data marks significant progress in the effort to provide clinicians with the ability to make accurate and precise treatment recommendations that patients with NSCLC require.” 

Immunotherapy Response Score is available clinically as part of the Strata Select^TM test, which is covered for Medicare beneficiaries with advanced solid tumors seeking additional treatment. Learn more here.