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
- Conditions
- BRAF V600 Mutation Positive Melanoma
- Registration Number
- NCT06337617
- Lead Sponsor
- Novartis Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
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
None specified
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Real-world overall response rate (rwORR) 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 Outcome Measures
Name Time Method 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 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 rwPFS was defined as the time from the start of treatment to the first documented disease progression or death due to any cause.
Number and percentage of patients with systemic anti-neoplastic treatment after D+T Up to approximately 2.6 years Number and percentage of patients per metastases Baseline Eastern Cooperative Oncology Group (ECOG) performance status Baseline 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).
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 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 rwPFS was defined as the time from the start of treatment to the first documented disease progression or death due to any cause.
Real-world overall survival (rwOS) since D+T initiation (FAS) Up to approximately 2.6 years rwOS was defined as the time from start of treatment to death due to any cause.
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 rwOS was defined as the time from start of treatment to death due to any cause.
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 per type of 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 Number and percentage of patients per reason for D+T treatment change Up to approximately 2.2 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 rwDCR was defined as the percentage of patients with a best overall response of complete response (CR) or partial response (PR) or stable disease (SD) or non-CR or non-progressive disease (non-PD), per RECIST version 1.1 or as documented per physician assessment, as available.
Mean total dosage for all radiotherapy Baseline Real-world duration of response (rwDOR) of dabrafenib plus trametinib Up to approximately 2.6 years For the subset of patients with CR or PR, rwDORn was defined as the time from the date of the first documented CR or PR per RECIST version 1.1 or as documented per physician assessment as available, to the first disease progression or death due to any cause.
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 rwPFS was defined as the time from the start of treatment to the first documented disease progression or death due to any cause.
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 AESIs were defined based on the case retrieval strategy file available at the time of analysis.
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 rwOS was defined as the time from start of treatment to death due to any cause.
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
Trial Locations
- Locations (1)
Novartis
🇨🇳Shanghai, China