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Association details:
| Biomarker: | BRAF V600K |
|---|---|
| Cancer: | Melanoma |
| Drug: | Tafinlar (dabrafenib) (BRAF inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Excerpt:
...NCCN Panel recommends BRAF inhibitor monotherapy only in those rare cases where combination therapy is contraindicated. In such cases, BRAF inhibitor monotherapy remains a treatment option especially if the patient is not an appropriate candidate for immune checkpoint inhibitor therapy. Dabrafenib/trametinib, vemurafenib/cobimetinib, and encorafenib/binimetinib combination therapy regimens are FDA approved for the treatment of patients with unresectable or distant metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test.
Source:
Title:
A Study of GSK2118436 in BRAF Mutant Metastatic Melanoma
Excerpt:
...Number of Participants With a Best Overall Response of CR or PR as Assessed by the Investigator and an Independent Reviewer for Participants Who Had a BRAF V600K Mutation`Progression-free Survival (PFS) as Assessed by the Investigator and an Independent Reviewer for Participants Who Had a BRAF V600E Mutation`Progression-free Survival (PFS) as Assessed by the Investigator and an Independent Reviewer for Participants Who Had a BRAF V600K Mutation`Duration of Response as Assessed by the Investigator and an Independent Reviewer for Participants Who Had a BRAF V600E Mutation`Duration of Response as Assessed by the Investigator and an Independent Reviewer for Participants Who Had a BRAF V600K Mutation`Overall Survival for Participants Who Had a BRAF V600E Mutation`Overall Survival for Participants Who Had a BRAF V600K Mutation`Number of Participants With AEs and Serious Adverse Events (SAEs)`Number of Participants With Change From Baseline in Clinical Chemistry and Hematology Toxicity Grades`Number of Participants With Change From Baseline in Temperature and Pulse Rate`Number of Participants With Increase From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)`Number of Participants With Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Levels...
Trial ID:
Source:
Title:
A Study of GSK2118436 in BRAF Mutant Metastatic Melanoma to the Brain
Excerpt:
...- Histologically confirmed metastatic melanoma (Stage IV), carrying BRAF V600E- or V600K-mutation....
Trial ID:
More C2 evidence
Source:
Title:
A Study of GSK2118436 as a Single Agent in Treatment Naïve and Previously Treated Subjects with BRAF Mutation-Positive Metastatic Melanoma to the Brain
Excerpt:
...5.Histologically confirmed metastatic melanoma (Stage IV), carrying BRAF V600E- or V600K-mutation as determined by central testing. ...
Trial ID:
Less C2 evidence
Source:
Title:
RAF Inhibitor Dabrafenib (GSK2118436) is Active in Melanoma Brain Metastases, Multiple BRAF Genotypes and Diverse Cancers
Excerpt:
Among the 18 melanoma patients with V600K who were treated at all doses, the response rate was 39% (95% CI 17·3–64·3) and the confirmed response rate was 22% (95% CI 6·4–47·6).
DOI:
10.1016/S0140-6736(12)60398-5
Trial ID:
