OBJECTIVES : Although clinical trials have shown that novel immuno-oncology (IO) and targeted therapies (TT) improve clinical outcomes, monitoring longitudinal treatment patterns and outcomes among patients in real-world settings is crucial. Here, we describe the development of NOBLE (Novartis Braf+ meLanoma patients ObsErvational) dataset, to inform critical questions about risk factors, treatment patterns, real-world outcomes, and complement clinical trial data.

METHODS : We harmonized and combined two oncology-specific electronic health record (EHR) databases – Flatiron Health Spotlight and Concerto custom data – to form the NOBLE dataset. Patients included were aged ≥18 years, had documented BRAF+ metastatic melanoma, evidence of treatment with IO or TT between 2015 and 2018, and ≥6 months of follow-up. Data was harmonized by a thorough data audit and validation process for all clinical, demographic, treatment, and mortality information. Progression information was harmonized such that results were based on review from provider report; variations in reporting results of biomarker testing (e.g. BRAF) from different laboratories were normalized; business rules of treatment patterns were established with experts and cross-validated with treatment guidelines and product labels.

RESULTS : 1,043 BRAF+ metastatic melanoma patients were included in the NOBLE dataset (as of June 2019), 698 from Flatiron and 345 from Concerto. The mean age was 60.7±14.2 years, 63% were male, and 94% were white. Patients in Flatiron were slightly older than those in Concerto (61.5 years vs. 59.2 years), but other patient characteristics and treatment patterns were similar. Similar unadjusted progression and mortality rates were seen in Concerto and Flatiron.

CONCLUSIONS : The NOBLE dataset enhances the breadth and depth of information by providing an increased sample size and enriched data elements for observing outcomes and treatment patterns longitudinally. This dataset is a novel data source that will enable researchers to gain insights into long-term real-world treatment patterns and outcomes among patients with advanced melanoma.