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Association details:
| Biomarker: | BRAF V600K |
|---|---|
| Cancer: | Melanoma |
| Drug: | Braftovi (encorafenib) (BRAF inhibitor, cRAF inhibitor) + Mektovi (binimetinib) (MEK inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Excerpt:
MEKTOVI is a kinase inhibitor indicated, in combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.
Test:
Source:
Title:
Encorafenib plus binimetinib versus vemurafenib or encorafenib in patients with BRAF-mutant melanoma (COLUMBUS): a multicentre, open-label, randomised phase 3 trial
Excerpt:
COLUMBUS was conducted as a two-part, randomised, open-label phase 3 study...Eligible patients were aged 18 years or older and had histologically confirmed locally advanced (American Joint Committee on Cancer [AJCC] stage IIIB, IIIC, or IV), unresectable or metastatic cutaneous melanoma, or unknown primary melanoma; a BRAF V600E or BRAF V600K mutation;...1345 screened patients were randomly assigned to either the encorafenib plus binimetinib group (n=192), the encorafenib group (n=194), or the vemurafenib group (n=191)….median progression-free survival was 14·9 months (95% CI 11·0–18·5) in the encorafenib plus binimetinib group and 7·3 months (5·6–8·2) in the vemurafenib group (hazard ratio [HR] 0·54, 95% CI 0·41–0·71; two-sided p<0·0001)....Encorafenib plus binimetinib could represent a new treatment option for patients with BRAF-mutant melanoma.
DOI:
https://doi.org/10.1016/S1470-2045(18)30142-6
Trial ID:
Source:
Title:
Study Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in BRAF Mutant Melanoma
Excerpt:
...- Presence of BRAF V600E or V600K mutation in tumor tissue prior to randomization...
Trial ID:
Source:
Title:
A Clinical Trial of Three Study Medicines (Encorafenib, Binimetinib, and Pembrolizumab) in Patients With Advanced or Metastatic Melanoma
Excerpt:
...- Documented evidence of a BRAF V600E or V600K mutation in melanoma tumor tissue as previously determined by either PCR or NGS-based local laboratory assay (eg, US FDA-approved test, CE-marked [European conformity] in vitro diagnostic in EU countries, or equivalent), obtained during the course of normal clinical care, in a CLIA- or similarly certified laboratory....
Trial ID:
More C2 evidence
Source:
Title:
Pharmacokinetic Drug-drug Interaction Study of Encorafenib and Binimetinib on Probe Drugs in Patients With BRAF V600-mutant Melanoma or Other Advanced Solid Tumors
Excerpt:
...- Presence of BRAF V600E and/or V600K mutation in tumor tissue prior to enrollment, as determined using a local test;...
Trial ID:
Source:
Title:
Adjuvant Encorafenib and Binimetinib in High-risk Stage II Melanoma With a BRAF Mutation.
Excerpt:
...- Available tumour sample for central determination of the BRAF V600E/K mutation....
Trial ID:
Source:
Title:
Encorafenib and Binimetinib Before Local Treatment in Patients With BRAF Mutant Melanoma Metastatic to the Brain
Excerpt:
...- Presence of a BRAF V600E or V600K mutation, or both, in their tumour tissue....
Trial ID:
Source:
Title:
Hepatic Impairment Study of Encorafenib in Combination With Binimetinib in BRAF Melanoma
Excerpt:
...Presence of BRAF V600E or V600K mutation in tumour tissue prior to enrolment, as previously determined using a local test at any time prior to Screening...
Trial ID:
Source:
Title:
Study of the Combination of Binimetinib and Encorafenib in Adolescent Patients With Unresectable or Metastatic BRAF V600-mutant Melanoma
Excerpt:
...- Presence of BRAF V600E or V600K mutation in tumor tissue as determined by a local or central laboratory -...
Trial ID:
Source:
Title:
Encorafenib used with binimetinib versus placebo in BRAF mutant stage IIB/C melanoma after surgery to evaluate the efficacy and safety in preventing melanoma recurrence
Excerpt:
...Molecular Pre-screening 1.Before any related study activity, written informed consent must be given according to ICH/GCP, and national/local regulations; 2.Male or female ≥ 18 years of age; 3.Surgically resected, with tumor free margins, and histologically/pathologically confirmed new diagnosis of stage II (pT3b-pT4bN0) cutaneous melanoma per AJCC 8th edition; 4.Sentinel node (SN) staged node negative (pN0); 5.Sentinel node (SN) biopsy within 14 weeks from initial diagnosis of melanoma; 6.Available tumor sample for central determination of the BRAFV600E/K mutation. ...
Trial ID:
