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    Tumor agnostic-research: Using RWE to support trial data in rare patient populations

    Summary of: Snow T, Swaminathan A, Snider J, Schrock AB, Li G, Alexander BM, Singal G, Castellanos EH, McCusker M. Characteristics and outcomes of real-world patients with microsatellite instability-high solid tumors treated with pembrolizumab monotherapy after FDA approval. Poster presented at: 2020 Annual Meeting of the American Society of Clinical Oncology (ASCO); May, 2020; Chicago, IL.

    Flatiron Health's Tamara Snow discusses the background of this study and how patients with MSI-H solid tumors responded to pembrolizumab in real-world care.

    Our summary

    In May 2017, pembrolizumab monotherapy was granted the first tumor-agnostic, biomarker-based FDA approval in oncology for patients with microsatellite instability high (MSI-H) or mismatch repair (MMR) deficient tumors.

    As tumor-agnostic therapies are a new treatment paradigm, it is important to assess their use and effectiveness in routine clinical practice

    Using EHR-derived real-world data, this study examined characteristics and outcomes in a cohort of patients with solid tumors identified as MSI-H who received their first pembrolizumab treatment after May 2017.

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    Why this matters

    With the advancements made in broad-based genomic sequencing and the ability to link this information with detailed clinical data obtained from electronic health records, researchers were able to look at the use of pembrolizumab in patients with MSI-H solid tumors across 36 different tumor types.

    These insights provided supporting real-world evidence of the trial data in a rare, pan-tumor cohort where conducting additional trials would be challenging. Additionally, this research highlights the potential for researchers to utilize EHR-derived real-world data linked with genomic information to evaluate complex genomic biomarkers in a pan-tumor, real-world cohort to support the adoption of tumor-agnostic cancer treatments.

    Read the research