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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with high tumor burden (HTB) | |||
| Patients with low tumor burden (LTB) | |||
| Patients with central nervous system (CNS) metastases | |||
| Patients with without CNS metastases | |||
| 1L IO-refractory patients |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean age of 1L dab/tram-treated BRAF+ MM patients | Baseline | |
| Number and percentage of 1L dab/tram-treated BRAF+ MM patients who identify per sex | Baseline | |
| Number and percentage of 1L dab/tram-treated BRAF+ MM patients per race category | Baseline | |
| Number and percentage of 1L dab/tram-treated BRAF+ MM patients per ethnicity category | Baseline | |
| Number and percentage of 1L dab/tram-treated BRAF+ MM patients per geographic region | Baseline | |
| Number and percentage of 1L dab/tram-treated BRAF+ MM patients per type of medical practice | Baseline | |
| Number and percentage of 1L dab/tram-treated BRAF+ MM patients per insurance type | 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). | Baseline |
| Number and percentage of 1L dab/tram-treated BRAF+ MM patients per location of metastatic site |
| Measure | Description | Time Frame |
|---|---|---|
| Mean age of 1L IO-refractory patients with BRAF+ MM | Baseline | |
| Number and percentage of 1L IO-refractory patients with BRAF+ MM who identify per sex | Baseline | |
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Inclusion criteria:
Diagnosis of melanoma (ICD-9 172x & ICD-10 C43 or D03x)
≥2 documented clinical encounters on different days in the Flatiron network on or after 01 January 2011
Pathologic unresectable stage III or IV at initial diagnosis after 01 January 2011, or earlier stage disease accompanied by development of a first locoregional recurrence after 01 January 2011
Diagnosis of MM after 01 January 2011
Evidence of a BRAF-positive result at any point in time
Treatment with one of the following 1L therapies on or after 01 January 2014:
At least 18 years of age at the time of initiation of 1L therapy
At least 6-months of continuous follow-up from the time of initiation of 1L therapy
Exclusion 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 | East Hanover | New Jersey | 07936 | United States |
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| Baseline |
| Alanine aminotransferase (ALT) levels in 1L dab/tram-treated BRAF+ MM patients | Baseline |
| Aspartate aminotransferase (AST) levels in 1L dab/tram-treated BRAF+ MM patients | Baseline |
| Lactate dehydrogenase (LDH) levels in 1L dab/tram-treated BRAF+ MM patients | Baseline |
| Number and percentage of 1L dab/tram-treated BRAF+ MM patients treated with 2L therapy | Up to approximately 2 years |
| Time from the start of 1L dab/tram therapy until the start of 2L therapy | 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. | 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. | Up to approximately 2 years |
| Number and percentage of 1L IO-refractory patients with BRAF+ MM per race category |
| Baseline |
| Number and percentage of 1L IO-refractory patients with BRAF+ MM per ethnicity category | Baseline |
| Number and percentage of 1L IO-refractory patients with BRAF+ MM per geographic region | Baseline |
| Number and percentage of 1L IO-refractory patients with BRAF+ MM per type of medical practice | Baseline |
| Number and percentage of 1L IO-refractory patients with BRAF+ MM per insurance type | 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). | Baseline |
| Number and percentage of 1L IO-refractory patients with BRAF+ MM per location of metastatic site | Baseline |
| Alanine aminotransferase (ALT) levels in 1L IO-refractory patients with BRAF+ MM | Baseline |
| Aspartate aminotransferase (AST) levels in 1L IO-refractory patients with BRAF+ MM | Baseline |
| Lactate dehydrogenase (LDH) levels in 1L IO-refractory patients with BRAF+ MM | Baseline |
| Time from the first disease progression until next disease progression in 1L IO-refractory patients with BRAF+ MM | Up to approximately 2 years |
| Number and proportion of patients remaining on 1L IO therapy following disease progression | Up to approximately 2 years |
| Time patients remained on 1L IO therapy following disease progression | Up to approximately 2 years |
| Number and percentage of patients treated with 2L therapy, overall and by therapy type | Up to approximately 2 years |
| Time from the start of 1L IO until the start of 2L therapy | Up to approximately 2 years |
| Time from the first disease progression until the start of 2L therapy | 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. | 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. | Up to approximately 2 years |