This was a retrospective, longitudinal, observational study conducted using the Flatiron Health electronic health record (EHR)-derived database. BRAF+ advanced or metastatic (i.e., stage III or IV) melanoma patients treated at oncology practices across the US were identified for potential inclusion. All included patients were aged ≥18 years and required to have a diagnosis of melanoma (International Classification of Diseases (ICD)-9 172.x \& ICD-10 C43 or D03x), a pathologic unresectable stage III or IV diagnosis, subsequent first-line (1L) treatment with either immunotherapy (IO) (nivolumab, pembrolizumab, ipilimumab + nivolumab) or targeted therapy (TT) dafratenib + trametinib (dab/tram) on or after 01 January 2014, and evidence of a BRAF-positive result at any point in time.
Study Type
OBSERVATIONAL
Enrollment
785
Novartis
East Hanover, New Jersey, United States
Mean age of 1L dab/tram-treated BRAF+ MM patients
Time frame: Baseline
Number and percentage of 1L dab/tram-treated BRAF+ MM patients who identify per sex
Time frame: Baseline
Number and percentage of 1L dab/tram-treated BRAF+ MM patients per race category
Time frame: Baseline
Number and percentage of 1L dab/tram-treated BRAF+ MM patients per ethnicity category
Time frame: Baseline
Number and percentage of 1L dab/tram-treated BRAF+ MM patients per geographic region
Time frame: Baseline
Number and percentage of 1L dab/tram-treated BRAF+ MM patients per type of medical practice
Time frame: Baseline
Number and percentage of 1L dab/tram-treated BRAF+ MM patients per insurance type
Time frame: Baseline
Number and percentage of 1L dab/tram-treated BRAF+ MM patients with an Eastern Cooperative Oncology Group (ECOG) score of 0, 1, 2, 3, or 4
ECOG performance status describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.). Scores can range from a lower value of 0 (fully active, able to carry on all pre-disease performance without restriction) up to 5 (dead).
Time frame: Baseline
Number and percentage of 1L dab/tram-treated BRAF+ MM patients per location of metastatic site
Time frame: Baseline
Alanine aminotransferase (ALT) levels in 1L dab/tram-treated BRAF+ MM patients
Time frame: Baseline
Aspartate aminotransferase (AST) levels in 1L dab/tram-treated BRAF+ MM patients
Time frame: Baseline
Lactate dehydrogenase (LDH) levels in 1L dab/tram-treated BRAF+ MM patients
Time frame: Baseline
Number and percentage of 1L dab/tram-treated BRAF+ MM patients treated with 2L therapy
Time frame: Up to approximately 2 years
Time from the start of 1L dab/tram therapy until the start of 2L therapy
Time frame: Up to approximately 2 years
Real-world progression-free survival (rwPFS) for 1L dab/tram-treated BRAF+ MM patients
rwPFS was defined as the time from the start of 1L dab/tram therapy until first progression or death from any cause.
Time frame: Up to approximately 2 years
Overall survival (OS) for 1L dab/tram-treated BRAF+ MM patients
OS was defined as the time from the start of 1L dab/tram therapy until death from any cause.
Time frame: Up to approximately 2 years
Mean age of 1L IO-refractory patients with BRAF+ MM
Time frame: Baseline
Number and percentage of 1L IO-refractory patients with BRAF+ MM who identify per sex
Time frame: Baseline
Number and percentage of 1L IO-refractory patients with BRAF+ MM per race category
Time frame: Baseline
Number and percentage of 1L IO-refractory patients with BRAF+ MM per ethnicity category
Time frame: Baseline
Number and percentage of 1L IO-refractory patients with BRAF+ MM per geographic region
Time frame: Baseline
Number and percentage of 1L IO-refractory patients with BRAF+ MM per type of medical practice
Time frame: Baseline
Number and percentage of 1L IO-refractory patients with BRAF+ MM per insurance type
Time frame: Baseline
Number and percentage of 1L IO-refractory patients with BRAF+ MM with an ECOG score of 0, 1, 2, 3, or 4
ECOG performance status describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.). Scores can range from a lower value of 0 (fully active, able to carry on all pre-disease performance without restriction) up to 5 (dead).
Time frame: Baseline
Number and percentage of 1L IO-refractory patients with BRAF+ MM per location of metastatic site
Time frame: Baseline
Alanine aminotransferase (ALT) levels in 1L IO-refractory patients with BRAF+ MM
Time frame: Baseline
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Aspartate aminotransferase (AST) levels in 1L IO-refractory patients with BRAF+ MM
Time frame: Baseline
Lactate dehydrogenase (LDH) levels in 1L IO-refractory patients with BRAF+ MM
Time frame: Baseline
Time from the first disease progression until next disease progression in 1L IO-refractory patients with BRAF+ MM
Time frame: Up to approximately 2 years
Number and proportion of patients remaining on 1L IO therapy following disease progression
Time frame: Up to approximately 2 years
Time patients remained on 1L IO therapy following disease progression
Time frame: Up to approximately 2 years
Number and percentage of patients treated with 2L therapy, overall and by therapy type
Time frame: Up to approximately 2 years
Time from the start of 1L IO until the start of 2L therapy
Time frame: Up to approximately 2 years
Time from the first disease progression until the start of 2L therapy
Time frame: Up to approximately 2 years
rwPFS for 1L IO-refractory patients with BRAF+ MM
rwPFS was defined as the time from the first disease progression until next progression or death from any cause.
Time frame: Up to approximately 2 years
OS for 1L IO-refractory patients with BRAF+ MM
OS was defined as the time from the first disease progression until death from any cause.
Time frame: Up to approximately 2 years