Caris Life Sciences Publishes Study Featuring the Largest Real-World Cohort of Tissue-Agnostic Indications Revealing Over 20 Percent of Patients Are Eligible for "Pan-Cancer" Therapies
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IRVING, Texas, March 20, 2025 ~ In a recent publication in Nature Communications, Caris Life Sciences® (Caris) has revealed groundbreaking findings on the use and clinical benefits of tissue-agnostic therapies. As a leading next-generation AI TechBio company and precision medicine pioneer, Caris utilized their extensive clinico-genomic dataset to evaluate real-world outcomes for patients eligible for these powerful "pan-cancer" therapies.

The study, titled "Real-world evidence provides clinical insights into tissue-agnostic therapeutic approvals," focused on the use of tissue-agnostic therapies that target specific molecular biomarkers across numerous cancer types. The key findings of the study include:

- More than 20 percent of patients are candidates for a tissue-agnostic drug.

- Approximately five percent of patients who lacked any tumor-specific indication were found to carry a tissue-agnostic indication and became eligible for treatment with these drugs.

- Tissue-agnostic therapy uptake was poor for rare indications, highlighting the need for enhanced clinical education.

- Current tissue-agnostic indications could potentially be expanded, as evidenced by clinical benefits in tumor types and drugs of the same class that were not investigated in the original clinical trials.

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According to George W. Sledge, Jr., MD, EVP and Chief Medical Officer of Caris and study author, "By harnessing the power of Caris' large clinico-genomic dataset, we have shown that tissue-agnostic drugs produce different outcomes in different tissues." He also noted that there is evidence of clinical benefit beyond approved indications, demonstrating the potential of real-world data to inform the use of tissue-agnostic drug approvals and improve patient outcomes.

David Spetzler, MS, PhD, MBA, President of Caris and study author stated that "Caris has generated one of the most extensive clinico-genomic datasets in oncology through years of comprehensive molecular profiling." He added that their advanced analyses of real-world data have enabled them to uncover valuable clinical insights for large patient populations. The study found that one in five patients were eligible for a tissue-agnostic drug, highlighting the widespread impact of their findings.

The study utilized a real-world database of 295,316 molecularly profiled tumor samples with associated clinical outcomes data across 57 tumor types. It investigated the utility and uptake of six tissue-agnostic therapies: pembrolizumab, larotrectinib, entrectinib, dostarlimab, dabrafenib, and selpercatinib. The results showed that at least one current FDA-approved tissue-agnostic indication was detected in 21.5% of patients, including 5.4% who lacked any tumor-specific indication.

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Furthermore, the study revealed significant differences in outcomes for pembrolizumab across different tumor types for the most common indications (TMB-High and MSI-High/dMMR), indicating that these therapies are not truly tissue-agnostic. Additionally, clinical benefits were observed in tumor types and drugs of the same class that were not investigated in pivotal clinical trials, suggesting the potential expansion of therapeutic options for a given tissue-agnostic indication.

Caris' proprietary Caris Platform is designed to capture and analyze molecular information from tissue and blood in a comprehensive manner. This powerful set of precision medicine solutions includes Whole Exome Sequencing (WES) and Whole Transcriptome Sequencing (WTS) as standard practice. With sector-leading depth of coverage, Caris is able to provide accurate detection of low-frequency biomarkers relevant to patient treatment.

In addition to DNA and RNA analysis, Caris also evaluates protein biomarkers through an extensive menu of immunohistochemical (IHC) tests analyzed in a tumor-type specific manner. This comprehensive approach provides an individualized molecular blueprint of a patient's disease, allowing for personalized treatment pathways and ultimately driving superior clinical outcomes.

The findings from this study demonstrate the immense potential of Caris' extensive real-world dataset to inform the clinical use of tissue-agnostic drug approvals and improve outcomes for patients with cancer. With their advanced technology and commitment to precision medicine, Caris is paving the way for a more personalized approach to cancer treatment.
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