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

Study Overview
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Brief Summary
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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.

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

Conditions
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BRAF v600 Mutated Metastatic Melanoma

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dab/tram<br>Patients received dabrafenib and trametinib treatment | |
| Enco/bini<br>Patients received encorafenib and binimetenib treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |