Metastatic Melanoma
Conditions
Brief summary
Brief summary The purpose of this study is to compare how effective, encorafenib plus binimetinib is in the real-world and clinical trial settings. And produce results to show that combining data on encorafenib plus binimetinib from both the real-world and clinical trial settings is possible for future research studies. This study group is identified from the database who: * Have taken at least 1 order or administration of encorafenib plus binimetinib treatment after the confirmation of having metastatic melanoma after 27 June 2018. * Are at least 18 years of age at the time of first encorafenib plus binimetinib initiation (index date). * Had never received encorafenib plus binimetinib or had received first-line immunotherapy at the start of the study. * Have ECOG status of 0 or 1 at the index date. * have available data on the number of deaths in an area or group of people. Patients will be followed from the date that the patient started the first encorafenib plus binimetinib treatment (treatment initiation) up to their last date of data availability. Last date of data availability could be the date of following events: patient lost to follow up at the clinic, death, or end of the database (January 2020). The database timeframe is June 2018 to January 2020.
Interventions
DRUGEnco+bini
Patients with BRAF mutant + receiving encorafenib and binimetinib combination treatment
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of melanoma (International Classification of Diseases 9th or 10th Revision Clinical Modification - ICD-9-CM: 172.X; ICD-10-CM: C43.x) and secondary malignancy or metastasis (ICD-9-CM: 196.x, 197.x, 198.x; ICD-10-CM: C77.x, C78.x, C79.x). * Confirmed BRAF V600E/V600K activating mutation reported in the data based on laboratory or genetic analysis results. * At least 1 order or administration of ENCO+BINI treatment
Exclusion criteria
* Patients without information on mortality * Patients with ECOG performance status ≥ 2 (at the time of randomization for patients from COLUMBUS, during the baseline period for patients in Flatiron Electronic Health Record) * Patients with a history of or concurrent uveal or mucosal melanoma, basal cell or squamous cell carcinoma (as per trial inclusion criteria); this exclusion will also be applied to RWD patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | COLUMBUS: From date of randomization until death or censoring (approx 80.5 months); Flatiron: From index date until death due or censoring or end of follow-up period (approx 42.2 months) | As per COLUMBUS trial, OS was defined as the time from the date of randomization to the date of death due to any cause; if death was not observed, participants were censored at the date of last contact or the data analysis cut-off date, whichever occurred first. As per Flatiron EHR, OS was defined as the time from the index date to the date of death; participants without a date of death were censored at their last known activity date or the end of the follow-up period, whichever occurred first. Index date in each treatment group was defined as the date of treatment initiation. Kaplan-Meier analyses was used for analysis. |
Countries
United States
Participant flow
Recruitment details
Data of eligible participants with v-Raf murine sarcoma viral oncogene homolog B protein (BRAF) V-600 mutant melanoma who aged greater than or equal to 18 years at the time of initiating treatment with Encorafenib plus Binimetinib (ENCO+BINI) was collected retrospectively.
Pre-assignment details
Data sources: COLUMBUS trial (NCT01909453) and Flatiron Health Electronic Health Records (EHR) real-world database (RWD). Planned cohorts in this study: 1) ENCO+BINI, clinical trial data (CTD) from COLUMBUS; 2) ENCO+BINI (RWD) from Flatiron EHR. Available retrospective data was evaluated in this observational study from 21-Jul-2023 to 31-Dec-2023 \[approximately 5.35 months\].
Participants by arm
| Arm | Count |
|---|---|
| Encorafenib+Binimetinib (CTD) Participants with BRAFV600-mutant metastatic melanoma, who were enrolled between 30-December-2013 to 15-September-2020 in phase 3 COLUMBUS trial and treated with Encorafenib 450 mg QD and Binimetinib 45 mg BID (ENCO+BINI) were included. | 192 |
| Encorafenib+Binimetinib (RWD) Eligible participants with BRAFV600-mutant metastatic melanoma, identified from Flatiron Health Database between 27-June-2018 to 01-January-2022 and treated with Encorafenib 450 mg QD and Binimetinib 45 mg BID (ENCO+BINI) were included. | 83 |
| Total | 275 |
Baseline characteristics
| Characteristic | Encorafenib+Binimetinib (CTD) | Encorafenib+Binimetinib (RWD) | Total |
|---|---|---|---|
| Age, Continuous | 56.2 Years STANDARD_DEVIATION 13.6 | 60.4 Years STANDARD_DEVIATION 14.2 | 57.5 Years STANDARD_DEVIATION 13.8 |
| Race/Ethnicity, Customized White | 181 Participants | 71 Participants | 252 Participants |
| Sex: Female, Male Female | 77 Participants | 36 Participants | 113 Participants |
| Sex: Female, Male Male | 115 Participants | 47 Participants | 162 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 131 / 192 | 28 / 83 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Overall Survival (OS)
As per COLUMBUS trial, OS was defined as the time from the date of randomization to the date of death due to any cause; if death was not observed, participants were censored at the date of last contact or the data analysis cut-off date, whichever occurred first. As per Flatiron EHR, OS was defined as the time from the index date to the date of death; participants without a date of death were censored at their last known activity date or the end of the follow-up period, whichever occurred first. Index date in each treatment group was defined as the date of treatment initiation. Kaplan-Meier analyses was used for analysis.
Time frame: COLUMBUS: From date of randomization until death or censoring (approx 80.5 months); Flatiron: From index date until death due or censoring or end of follow-up period (approx 42.2 months)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Encorafenib+Binimetinib (CTD) | Overall Survival (OS) | 33.6 Months |
| Encorafenib+Binimetinib (RWD) | Overall Survival (OS) | 24.0 Months |
Comparison: Statistical analysis data is presented for Encorafenib+Binimetinib (RWD) relative to Encorafenib+Binimetinib (CTD) (reference).95% CI: [0.62, 1.72]