Comparative Effectiveness of Targeted Therapies in BRAF Positive Metastatic Melanoma in the US

Pfizer716 enrolled

Overview

This study aims to compare real-world effectiveness of BRAF/MEK inhibitors in BRAF-mutant metastatic melanoma patients in the United States by line of therapy. The Flatiron Health electronic health record (EHR) data from US cancer clinics will be used for this retrospective database analysis.

Study Type

OBSERVATIONAL

Enrollment

716

Conditions

Melanoma

Interventions

EncorafenibDRUG

450 mg QD

BinimetinibDRUG

45 mg BID

VemurafenibDRUG

960 mg BID for 28 days/cycle

Cobimetinib

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosed with melanoma based on International Classification of Disease 9th and 10th Revisions (ICD-9: 172.x; ICD-10: C43x, D03x) and ≥2 visits on different days in the Flatiron database on or after January 1, 2011. * Clinically confirmed diagnosis of melanoma with pathologic stages III or IV at initial diagnosis or earlier stage disease with a first locoregional or distant recurrence on or after January 1, 2011. * Age ≥18 years at the time of advanced melanoma diagnosis. * Evidence of ≥1 BRAF positive test result at any time based on laboratory or genetic analysis results. Exclusion Criteria: -• Patients with prior BRAF- or MEK-inhibitor therapy • Patients with ECOG performance status ≥ 2 (at the time of randomization for patients from COLUMBUS, during the baseline period for patients in Flatiron EHR)

Locations (1)

Pfizer Investigational Site

New York, New York, United States

Outcomes

Primary Outcomes

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 (92.7 months)

Data from ClinicalTrials.gov

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