A Multi-center Retrospective Study With Secondary Use of Data of Tafinlar (Dabrafenib) Plus Mekinist (Trametinib) in Chinese Patients With BRAF V600 Mutation Positive Melanoma

Novartis Pharmaceuticals1 site in 1 country90 target enrollmentMay 10, 2022

ConditionsBRAF V600 Mutation Positive Melanoma

Overview

Phase: N/A
Intervention: Not specified
Conditions: BRAF V600 Mutation Positive Melanoma
Sponsor: Novartis Pharmaceuticals
Enrollment: 90
Locations: 1
Primary Endpoint: Real-world overall response rate (rwORR)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This was a multi-center, observational, retrospective cohort study to evaluate the effectiveness and safety of dabrafenib in combination with trametinib in Chinese patients with unresectable or metastatic BRAF V600 mutation positive melanoma, for mucosal melanoma patients (Cohort A) and non-mucosal melanoma patients (Cohort B, cutaneous and acral melanoma), separately. Study population was identified as patients initiating dabrafenib plus trametinib from 01 May 2020 to 31 July 2022 who fulfilled the inclusion/exclusion criteria. The follow-up period ended at the earliest of the following: end of study observation period (i.e., 31 December 2022), death, upon withdrawal of consent or the last available record.

Registry

clinicaltrials.gov

Start Date

May 10, 2022

End Date

June 29, 2023

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Novartis Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Cohorts A and B:
•Initiated dabrafenib and trametinib combination therapy (D+T) according to approved label between 01 May 2020 and 31 July 2022
•Was ≥18 years old of age at the initiation of D+T
•Had at least one tumor assessment after initiation of D+T
•Written informed consent if requested by the study site
•Cohort A Only • Confirmed BRAF V600 mutation positive mucosal melanoma that was unresectable or metastatic
•Cohort B Only
•Confirmed BRAF V600 mutation positive non-mucosal melanoma (cutaneous and acral melanoma) that was unresectable or metastatic

Exclusion Criteria

•None specified

Outcomes

Primary Outcomes

Real-world overall response rate (rwORR)

Time Frame: Up to approximately 2.6 years

ORR was defined as the percentage of patients demonstrating a best overall response as complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or as documented per physician assessment, as available.

Secondary Outcomes

Number and percentage of patients per anatomic sites of origin(Baseline)
Number and percentage of patients per tumor stage(Baseline)
Number and percentage of patients per metastatic location(Baseline)
Mean Age(Baseline)
Lactate dehydrogenase (LDH) levels(Baseline)
Number and percentage of patients per surgical and medical procedure(Baseline)
Number and percentage of patients with prior anti-neoplastic drugs for melanoma per treatment intent(Baseline)
Percentage of patients per sex(Baseline)
Number of years of disease history at treatment initiation since initial melanoma diagnosis(Baseline)
Number of years of disease history at treatment initiation since unresectable or metastatic melanoma diagnosis(Baseline)
Number and percentage of patients with occurrence of tumor metastasis(Baseline)
Number and percentage of patients per type of surgery(Baseline)
Number and percentage of patients who had at least one radiotherapy for melanoma prior to D+T treatment(Baseline)
Number and percentage of patients per radiation site(Baseline)
Number and percentage of patients with prior radiotherapy for melanoma with best overall tumor response(Baseline)
Number and percentage of patients with dabrafenib plus trametinib treatment per line of treatment(Up to approximately 2.2 years)
Number and percentage of patients with dabrafenib plus trametinib treatment per treatment intent(Up to approximately 2.2 years)
Number and percentage of patients with dabrafenib plus trametinib treatment per treatment setting(Up to approximately 2.2 years)
rwPFS for dabrafenib plus trametinib (NMS), by immunotherapy use(Up to approximately 2.6 years)
Number and percentage of patients with systemic anti-neoplastic treatment after D+T(Up to approximately 2.6 years)
Number and percentage of patients with prior radiotherapy for melanoma per treatment intent(Baseline)
Number and percentage of patients with prior radiotherapy for melanoma per treatment setting(Baseline)
Number and percentage of patients per metastases(Baseline)
Eastern Cooperative Oncology Group (ECOG) performance status(Baseline)
Mean duration of D+T, if not ongoing to end of study follow-up(Up to approximately 2.2 years)
Real-world progression-free survival (rwPFS) for dabrafenib plus trametinib (FAS)(Up to approximately 2.6 years)
Real-world overall survival (rwOS) since D+T initiation (FAS)(Up to approximately 2.6 years)
Number and percentage of patients with serious adverse events (SAEs) (FAS)(Up to approximately 2.6 years)
rwOS since D+T initiation (MMS), by immunotherapy use(Up to approximately 2.6 years)
Real-world overall survival since the first anti-neoplastic drug treatment for advanced/metastatic melanoma (FAS)(Up to approximately 2.6 years)
Number and percentage of patients who had at least one surgery for melanoma prior to D+T treatment(Baseline)
Number and percentage of patients per name of surgery(Baseline)
Number and percentage of patients who had at least one anti-neoplastic drug for melanoma prior to D+T treatment(Baseline)
Number and percentage of patients with prior anti-neoplastic drug for melanoma per line of treatment(Baseline)
Number and percentage of patients with prior anti-neoplastic drug for melanoma per treatment type(Baseline)
Number and percentage of patients with prior anti-neoplastic drug for melanoma with best overall tumor response(Baseline)
Number and percentage of patients per prior anti-neoplastic drug for melanoma(Baseline)
Number and percentage of patients per type of D+T treatment change(Up to approximately 2.2 years)
Number and percentage of patients per reason for D+T treatment change(Up to approximately 2.2 years)
Number and percentage of patients with prior anti-neoplastic drug for melanoma per treatment setting(Baseline)
Number and percentage of patients per reason for immunotherapy discontinuation(Up to approximately 2.6 years)
rwORR of dabrafenib plus trametinib among non-mucosal melanoma patients (FAS)(Up to approximately 2.6 years)
Real-world disease control rate (rwDCR) of D+T (FAS)(Up to approximately 2.6 years)
Mean total dosage for all radiotherapy(Baseline)
Real-world duration of response (rwDOR) of dabrafenib plus trametinib(Up to approximately 2.6 years)
Time to treatment discontinuation (FAS)(Up to approximately 2.6 years)
rwPFS for dabrafenib plus trametinib (MMS), by immunotherapy use(Up to approximately 2.6 years)
Number and percentage of patients who had systemic anti-neoplastic treatment after D+T treatment per medication(Up to approximately 2.6 years)
Number and percentage of patients per concomitant medication(Up to approximately 2.2 years)
Number and percentage of patients with adverse events of special interest (AESIs) (FAS)(Up to approximately 2.6 years)
Number and percentage of patients with systemic anti-neoplastic treatment after D+T and treatment ongoing at end of follow up(Up to approximately 2.6 years)
Number and percentage of patients with systemic anti-neoplastic treatment after D+T per treatment type(Up to approximately 2.6 years)
Number and percentage of patients who had systemic anti-neoplastic treatment after D+T treatment(Up to approximately 2.6 years)
Real-world overall survival since the first anti-neoplastic drug for advanced/metastatic melanoma (NMS), by immunotherapy use(Up to approximately 2.6 years)
rwOS since D+T initiation (NMS), by immunotherapy use(Up to approximately 2.6 years)
Number and percentage of patients with systemic anti-neoplastic treatment after D+T with best overall tumor response(Up to approximately 2.6 years)
Number and percentage of patients with systemic anti-neoplastic treatment after D+T per line of treatment(Up to approximately 2.6 years)