Patient Characteristics, Associated Factors, and Clinical Outcomes of Prescribing Encorafenib and Binimetenib Versus Dabrafenib and Trametinib Among BRAF v600 Mutated Metastatic Melanoma Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- BRAF v600 Mutated Metastatic Melanoma
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 214
- Locations
- 1
- Primary Endpoint
- Assessment of clinical predictors for choice of first-line (1L) therapy between dab/tram and enco/bini
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Assessment of clinical predictors for choice of first-line (1L) therapy between dab/tram and enco/bini
Time Frame: Up to approximately 2 years
Secondary Outcomes
- Percentage of patients who discontinued treatment in 1L and associated reasons, overall and by cohort(Up to approximately 2 years)
- Percentage of patients switching from 1L dab/tram therapy to either another TT or IO 2L therapy(Up to approximately 2 years)
- Percentage of patients switching from 1L enco/bini therapy to either another targeted therapy (TT) or second-line (2L) immunotherapy (IO)(Up to approximately 2 years)
- Percentage of patients receiving enco/bini or dab/tram in the 1L of therapy(Up to approximately 2 years)