Trial Outcomes & Findings for A Study to Compare How Effective is Encorafenib Plus Binimetinib in Real-world and Clinical Trial Settings (NCT NCT05954546)
NCT ID: NCT05954546
Last Updated: 2025-02-05
Results Overview
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.
COMPLETED
275 participants
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)
2025-02-05
Participant Flow
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.
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 \[approximately 5.35 months\].
Participant milestones
| Measure |
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 once daily (QD) and Binimetinib 45 mg twice daily (BID) (ENCO+BINI) were included.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
192
|
83
|
|
Overall Study
COMPLETED
|
192
|
83
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Here, Number analyzed signifies number of participants for whom data was collected and was available to be reported.
Baseline characteristics by cohort
| Measure |
Encorafenib+Binimetinib (CTD)
n=192 Participants
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.
|
Encorafenib+Binimetinib (RWD)
n=83 Participants
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.
|
Total
n=275 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.2 Years
STANDARD_DEVIATION 13.6 • n=192 Participants
|
60.4 Years
STANDARD_DEVIATION 14.2 • n=83 Participants
|
57.5 Years
STANDARD_DEVIATION 13.8 • n=275 Participants
|
|
Sex: Female, Male
Female
|
77 Participants
n=192 Participants
|
36 Participants
n=83 Participants
|
113 Participants
n=275 Participants
|
|
Sex: Female, Male
Male
|
115 Participants
n=192 Participants
|
47 Participants
n=83 Participants
|
162 Participants
n=275 Participants
|
|
Race/Ethnicity, Customized
White
|
181 Participants
n=181 Participants • Here, Number analyzed signifies number of participants for whom data was collected and was available to be reported.
|
71 Participants
n=71 Participants • Here, Number analyzed signifies number of participants for whom data was collected and was available to be reported.
|
252 Participants
n=252 Participants • Here, Number analyzed signifies number of participants for whom data was collected and was available to be reported.
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Encorafenib+Binimetinib (CTD)
n=192 Participants
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.
|
Encorafenib+Binimetinib (RWD)
n=83 Participants
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.
|
|---|---|---|
|
Overall Survival (OS)
|
33.6 Months
Interval 25.5 to 39.5
|
24.0 Months
Interval 16.4 to
To estimate an upper limit of 95% confidence limit (CI), enough follow-up and events were required after the median OS reached. But beyond median OS, participants at risk and events were insufficient. Hence, upper limit of 95% CI could not be estimated.
|
Adverse Events
Encorafenib+Binimetinib (CTD)
Encorafenib+Binimetinib (RWD)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER