Abstract 4094: WAYFIND-R: Delivering a high-quality real-world data (RWD) global registry of patients diagnosed with a solid tumor and profiled with next-generation sequencing (NGS)

Abstract NGS-based, molecularly guided therapy is becoming a pivotal part of precision oncology. Rare molecular cancer subtypes pose difficulties in traditional clinical trials; however, collecting patient RWD can help elucidate the clinical utility of targeted therapies, molecular tumor boards (MTBs), and NGS-based genomic profiling. WAYFIND-R (NCT04529122) is a global registry that: 1) characterizes the treatments and clinical course of patients with cancer; 2) provides a data research platform to evaluate real-world treatment decisions and outcomes; 3) supports the design/conduct of epidemiological research and clinical trials. WAYFIND-R will provide key learnings on data quality, sharing, and privacy for contemporary disease registries. Unlike many disease registries, WAYFIND-R is global, prospective, longitudinal, generalizable (all clinically validated NGS-based tests of any panel size are permitted), and includes NGS testing and standardized data collection to enhance data quality and minimize missing data. WAYFIND-R includes adults with any type/stage of solid tumor profiled with NGS ≤3 months before enrollment. NGS details, patient sociodemographics, cancer characteristics, patient-relevant safety data, treatment decisions, and outcomes are collected at baseline and prospectively every ≥6 months. WAYFIND-R will initially operate in ~12 countries, followed by further global expansion, in academic centers, community hospitals, and private clinics with regular MTBs. By 2026, WAYFIND-R aims to enroll ~15,000 patients. A key component is the potential to explore global and local data within a secure analytics platform (also known as a trusted research environment), accessed through a visual dashboard to find treatment decisions for similar patients elsewhere. Researchers can access the patient-level dataset for correlative analyses, after independent scientific committee approval. WAYFIND-R’s methodological/operational aspects were guided by external experts and the European Medicines Agency. As of October 2021, 11 patients have been enrolled. WAYFIND-R will inform on best practice for NGS-based treatment decisions by clinicians, foster global collaborations between cancer centers (enabling robust conclusions regarding outcome data to be drawn), aid understanding of disparities in patients’ access to advanced diagnostics and therapies, and ultimately drive advances in precision oncology. Citation Format: Christophe Le Tourneau, Allan Hackshaw, Jean-Yves Blay, Jan Geissler, Clare Turnbull, Camille Perret, Olga Skatkova, Martina von Meyenn, Rodrigo Dienstmann. WAYFIND-R: Delivering a high-quality real-world data (RWD) global registry of patients diagnosed with a solid tumor and profiled with next-generation sequencing (NGS) [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2022; 2022 Apr 8-13. Philadelphia (PA): AACR; Cancer Res 2022;82(12_Suppl):Abstract nr 4094.