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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dab/tram | Patients received dabrafenib and trametinib treatment | ||
| Enco/bini | Patients received encorafenib and binimetenib treatment |
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| Measure | Description | Time Frame |
|---|---|---|
| Assessment of clinical predictors for choice of first-line (1L) therapy between dab/tram and enco/bini | Up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients receiving enco/bini or dab/tram in the 1L of 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 |
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Inclusion criteria
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This was a retrospective, noninterventional cohort study
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Pharmaceuticals | East Hanover | New Jersey | 07936 | United States |
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| 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 who discontinued treatment in 1L and associated reasons, overall and by cohort | Up to approximately 2 years |