Strata Oncology, Inc., a next-generation precision oncology company enabling smarter and earlier cancer treatment, today announced the publication of a new peer-reviewed study validating the clinical utility of the company’s proprietary pan-solid tumor predictive biomarker for anti-PD-1/PD-L1 checkpoint inhibitor monotherapy benefit, Immunotherapy Response Score (IRS). The study was published by Communications Medicine, a Nature publication.

Strata Oncology developed IRS using treatment data and comprehensive, clinically validated genomic and transcriptomic profiling of tumor tissue from the Strata Trial^®, an ongoing observational clinical trial evaluating the impact of molecular profiling for patients with advanced solid tumors. The biomarker algorithm, which was validated in an independent cohort of trial patients, captures the biology of the tumor and its microenvironment by combining tumor mutation burden (TMB) with quantitative expression of PD-L1, PD-1, ADAM12 and TOP2A. 

“Our Immunotherapy Response Score meets a significant unmet medical need for an integrative diagnostic test that better predicts likelihood of benefit from anti-PD-1/PD-L1 checkpoint inhibitor monotherapy, across solid tumor types,” said Scott Tomlins, M.D., Ph.D., Strata Oncology co-founder and Chief Medical Officer. “Current pan-tumor biomarkers for these treatments identify only a fraction of responsive patients, meaning far too many people who could benefit from these therapies are not being identified.”

Tomlins continued: “Additionally, immunotherapy is now often combined with chemotherapy. Our exploratory data in non-small cell lung cancer indicate that IRS may be a useful tool to help determine which patients can achieve similar benefit without the toxic effects of chemotherapy.”

Key findings from the study include:

• IRS predicted real-world progression-free survival and overall survival in anti-PD-1/PD-L1 monotherapy treated patients across tumor types
• IRS-high status predicted similar duration of benefit as tumor mutational burden (TMB)-high status across tumor types, but identified twice as many patients who may benefit from checkpoint inhibitor treatment as TMB
• In non-small cell lung cancer (NSCLC) patients who were IRS-high, there was no significant benefit of combination therapy (pembrolizumab + chemotherapy) compared to monotherapy (pembrolizumab)

“Immunotherapy has transformed cancer care and now with IRS we have the ability to predict benefit across tumor types,” said Dan Rhodes, Ph.D., Strata Oncology co-founder and Chief Executive Officer. “We are excited to put this novel biomarker into the hands of physicians to help them ensure every patient gets their best possible therapy.”