^
Association details:
| Biomarker: | BRAF V600E |
|---|---|
| Cancer: | Melanoma |
| Drug: | Tafinlar (dabrafenib) (BRAF inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Excerpt:
TAFINLAR is a kinase inhibitor indicated as a single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test.
Test:
Source:
Title:
Phase III, randomized, open-label, multicenter trial (BREAK-3) comparing the BRAF kinase inhibitor dabrafenib (GSK2118436) with dacarbazine (DTIC) in patients with BRAFV600E-mutated melanoma.
Excerpt:
Pts with previously untreated, unresectable stage III or IV BRAFV600E-mutated melanoma were randomized (3:1) and stratified by stage to dabrafenib (150 mg po bid) or DTIC (1000 mg/m2, IV, q3w)....This phase III trial (NCT01227889) compared progression-free survival (PFS) in pts with advanced MM treated either with dabrafenib or dacarbazine (DTIC)…. Median PFS was 5.1 months for dabrafenib and 2.7 for DTIC….Confirmed RR was 53% for dabrafenib and 19% for DTIC. Benefits in PFS and RR were observed in all subgroups evaluated.... Dabrafenib demonstrated a significant improvement in PFS and ORR over DTIC with an acceptable safety profile.
DOI:
10.1200/jco.2012.30.18_suppl.lba8500
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:
Source:
Title:
A Study Comparing GSK2118436 to Dacarbazine (DTIC) in Previously Untreated Subjects With BRAF Mutation Positive Advanced (Stage III) or Metastatic (Stage IV) Melanoma
Excerpt:
...- Has advanced (unresectable Stage III) or metastatic (Stage IV) melanoma that is BRAF mutation positive (V600E)...
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:
Source:
Title:
A Phase I Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of GSK2118436 in Subjects With Solid Tumors
Excerpt:
...Must have BRAF positive melanoma with the V600E mutation....
Trial ID:
Source:
Title:
A Study of GSK2118436 in BRAF Mutant Metastatic Melanoma
Excerpt:
...The analysis was performed on Primary efficacy Population which comprised of all participants who received at least one dose of GSK2118436 (All Treated Participants Population) and had a BRAF V600E mutation.`...
Trial ID:
Less C2 evidence
Source:
Title:
Dabrafenib and Trametinib in Patients With Tumors With BRAF V600E Mutations: Results of the NCI-MATCH Trial Subprotocol H
Published date:
08/06/2020
Excerpt:
Subprotocol H (EAY131-H) of the NCI-MATCH platform trial sought to investigate the selective BRAF inhibitor dabrafenib and the MEK1/2 inhibitor trametinib in patients with solid tumors, lymphomas, or multiple myeloma whose tumors harbored a BRAFV600 mutation...The confirmed ORR was 38% (90% CI, 22.9% to 54.9%) with P < .0001 against a null rate of 5%, and PFS was 11.4 months (90% CI, 8.4 to 16.3 months)...Seven patients had a duration of response of > 12 months, including 4 patients with a duration of response of > 24 months. An additional 8 patients had a PFS > 6 months. The median overall survival was 28.6 months...
DOI:
10.1200/JCO.20.00762
Source:
Title:
RAF Inhibitor Dabrafenib (GSK2118436) is Active in Melanoma Brain Metastases, Multiple BRAF Genotypes and Diverse Cancers
Excerpt:
At the RP2D in patients with V600 BRAF-mutant melanoma, a response rate of 69% (a confirmed response rate of 50%) was observed overall and a 78% response rate (a confirmed response rate of 56%) in V600E BRAF-mutant melanoma.
DOI:
10.1016/S0140-6736(12)60398-5
Source:
Title:
Phase II trial (BREAK-2) of the BRAF inhibitor dabrafenib (GSK2118436) in patients with metastatic melanoma
Excerpt:
Phase II study assessed the safety and clinical activity of dabrafenib in BRAF(V600E/K) mutation-positive metastatic melanoma (mut(+) MM)....In the BRAF(V600E) group, 45 patients (59%) had a confirmed response (95% CI, 48.2 to 70.3), including five patients (7%) with complete responses....In the BRAF(V600E) and BRAF(V600K) groups, median PFS was 6.3 months and 4.5 months, and median OS was 13.1 months and 12.9 months, respectively....Dabrafenib was well tolerated and clinically active in patients with BRAF(V600E/K) mut(+) MM.
DOI:
10.1200/JCO.2013.49.8691
Source:
Title:
Monitoring response to therapy in melanoma by quantifying circulating tumour DNA with droplet digital PCR for BRAF and NRAS mutations
Excerpt:
We present here the case of a 66 year-old male patient, diagnosed with an advanced melanoma in June 2011, and treated with Dabrafenib for double mutant metastatic disease...Mutational study of the tumor revealed a double BRAF mutation on V-600E and V600M...Almost surprisingly for the rapidity of the effect, one week later the lesion on the shoulder has reduced its size by 60% and one month later it has completely disappeared from sight.
DOI:
https://doi.org/10.1186/1756-8722-5-60
