Patient Characteristics, Associated Factors, and Clinical Outcomes of Prescribing Encorafenib and Binimetenib Versus Dabrafenib and Trametinib Among BRAF v600 Mutated Metastatic Melanoma Patients

Novartis Pharmaceuticals214 enrolled

Overview

This was a retrospective real-world evidence cohort study. The study was conducted using the NOBLE (Novartis Braf+ meLanoma patients ObsErvational) dataset, with a study period from 01 January 2011 to 31 May 2020. All included patients were ≥18 years of age and were required to have a diagnosis of unresectable stage III or IV melanoma (ICD-9 172.x \& ICD-10 C43 or D03x), treatment with dabrafenib and trametinib (dab/tram) or encorafenib and binimetenib (enco/bini) on or after 01 June 2018, and evidence of a BRAF-positive result prior to or up to 30 days after therapy initiation. No quota of centers was established a priori. Given the retrospective nature of this study, all patients who met the inclusion/exclusion criteria from the NOBLE dataset were included.

Study Type

OBSERVATIONAL

Enrollment

214

Conditions

BRAF v600 Mutated Metastatic Melanoma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria * Diagnosis of melanoma (ICD-9 172.x \& ICD-10 C43 or D03x) * Pathologic stage III (unresectable) or IV at initial diagnosis on or after 01 January 2011 * 1L treatment with enco/bini or dab/tram on or after 01 June 2018 * Evidence of a BRAF test * Evidence of a BRAF-positive result prior to or up to 30 days after 1L therapy initiation * At least 18 years of age at the time of initiation of 1L treatment Exclusion criteria * Documented receipt of a clinical trial treatment for cancer at any time on or after September 2015 * Diagnosis of a second primary cancer or secondary cancer following initiation of 1L metastatic melanoma (MM) treatment

Locations (1)

Outcomes

Primary Outcomes

Assessment of clinical predictors for choice of first-line (1L) therapy between dab/tram and enco/bini