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Association details:
| Biomarker: | BRAF V600E |
|---|---|
| Cancer: | Melanoma |
| Drug: | Mektovi (binimetinib) (MEK inhibitor) + Braftovi (encorafenib) (BRAF inhibitor, cRAF inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Excerpt:
BRAFTOVI is a kinase inhibitor indicated, in combination with binimetinib, 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:
Contribution of MEK Inhibition to BRAF/MEK Inhibitor Combination Treatment of BRAF-Mutant Melanoma: Part 2 of the Randomized, Open-Label, Phase III COLUMBUS Trial
Published date:
07/28/2023
Excerpt:
Eligible patients were 18 years and older with a histologically confirmed diagnosis of locally advanced, unresectable/metastatic cutaneous melanoma or unknown primary melanoma (American Joint Committee on Cancer [AJCC] stage IIIB, IIIC, or IV) and the presence of BRAFV600E and/or BRAFV600K mutation in tumor tissue....The median PFS (95% CI) was 12.9 months (10.9 to 14.9) for COMBO300 versus 9.2 months (7.4 to 11.1) for ENCO300 (parts 1 and 2) and 7.4 months (5.6 to 9.2) for ENCO300 (part 2)....COMBO300 improved PFS, ORR, and tolerability compared with ENCO300, confirming the contribution of binimetinib to efficacy and safety.
DOI:
10.1200/JCO.22.02322
Trial ID:
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:
Encorafenib used with binimetinib versus placebo in BRAF mutant stage II melanoma after surgery to evaluate the efficacy and safety in preventingmelanoma recurrence Encorafenib utilizzato con binimetinib rispetto al placebo nel melanoma in stadio II con mutazione BRAF dopo l'intervento chirurgico per valutare l'efficacia e la sicurezza nella prevenzione recidiva del melanoma
Excerpt:
...Melanoma determined locally to be V600E/K mutation-positive. ...
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:
More C2 evidence
Source:
Title:
A study of binimetinib and encorafenib in patients aged 12 to 17 with a specific type of melanoma (BRAF V600-mutant melanoma) that cannot be completely removed by surgery or that has spread to other areas in the body.
Excerpt:
...- Male or female 12 to < 18 years of age at the time of consent/assent.- Histologically confirmed diagnosis of locally advanced, unresectable or metastatic cutaneous melanoma or unknown primary melanoma American Joint Committee on Cancer Stage IIIB, IIIC, or IV.- Presence of BRAF V600E or V600K mutation in tumor tissue as determined by a local or central laboratory.- Evidence of at least one evaluable lesion (measurable or non-measurable) as detected by radiological or photographic methods based on RECIST v1.1.- Adequate cardiac function:a. ...
Trial ID:
Source:
Title:
Phase 2 Study of Encorafenib and Binimetinib Plus Pembrolizumab inParticipants With BRAF V600E/K Mutation-Positive Melanoma Who Progressed Duringor After Prior Treatment with Anti−PD-1 Therapy
Excerpt:
...Participants must meet the following key inclusion criteria to be eligible for enrollment into the study:- Male or female participants ≥18 years of age at the time of informed consent.- Histologically confirmed unresectable (Stage IIIB, IIIC, or IIID) or metastatic(Stage IV) cutaneous melanoma, according to the AJCC 8th edition.- Documented evidence of a BRAF V600E or V600K mutation.- Submission of adequate tumor tissue for central laboratory testing of BRAF V600E/K mutation and biomarkers is required for all participants during the screening period and prior to randomization.- Must have received only 1 prior line of systemic therapy for melanoma (either adjuvant therapy or first-line anti-PD-1 monotherapy (ie, nivolumab orpembrolizumab).- Must have anti-PD-1 resistant disease (primary or secondary) with confirmed diseaseprogression per RECIST v1.1 either during or after receipt of an approved anti-PD-1monotherapy (ie, nivolumab or pembrolizumab) for melanoma, defined according tothe SITC Immunotherapy Resistance Taskforce (Kluger et al, 2020).- Have at least 1 measurable lesion per RECIST v1.1.- ECOG PS of 0-1, and adequate organ and cardiac function, including LVEF ≥50%by cardiac imaging.`...
Trial ID:
Source:
Title:
A Study Comparing 3 Study Medicines (Encorafenib, Binimetinib, Pembrolizumab) to 2 Study Medicines (Ipilimumab and Nivolumab) in Patients With Advanced Melanoma
Excerpt:
...- Documented evidence of a BRAF V600E or V600K mutation....
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:
Source:
Title:
A Study to Compare How Effective is Encorafenib Plus Binimetinib in Real-world and Clinical Trial Settings
Excerpt:
...- Confirmed BRAF V600E/V600K activating mutation reported in the data based on laboratory or genetic analysis results....
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 Phase Ib/II Study of LGX818 in Combination With MEK162 in Adult Patients With BRAF Dependent Advanced Solid Tumors
Excerpt:
...- Written documentation of BRAF V600E mutation, or any other BRAF V600 mutation...
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:
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:
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:
A study comparing combination of Encorafenib + Binimetinib as a standard-dose and a High-dose Regimen in patients with BRAFV600-Mutant Melanoma Brain Metastasis
Excerpt:
...Presence of BRAFV600 mutation in tumor tissue previously determined by a local PCR or NGS-based assay at any time prior to Screening or by a central laboratory during Screening.5. ...
Trial ID:
Less C2 evidence
Source:
Title:
A phase 1b/2 study of the BRAF inhibitor encorafenib plus the MEK inhibitor binimetinib in patients with BRAF V600E/K-mutant solid tumors
Published date:
07/15/2020
Excerpt:
…phase 1b/2 study reports the safety and activity of the first combination use with BRAF inhibitor (BRAFi) encorafenib plus MEK inhibitor (MEKi) binimetinib in patients with BRAF V600E-mutant solid tumors…In the phase 2 cohorts, confirmed responses were seen in 2 of 11 (18%) evaluable mCRC patients, 11 of 26 (42%) evaluable BRAFi-pretreated melanoma patients, and 28 of 42 (67%) BRAFi-naïve melanoma patients…The combination of encorafenib (450 mg) plus binimetinib (45 mg) showed acceptable tolerability and encouraging activity in patients with BRAF V600-mutant tumors…
DOI:
10.1158/1078-0432.CCR-19-3550
Trial ID:
Source:
Title:
P-111 Tumor lysis syndrome induced by BRAF/MEK double blockade in a patient with metastatic melanoma
Published date:
04/15/2021
Excerpt:
CONTRADICTING EVIDENCE: A 51-year-old woman....The pleural biopsy confirmed the diagnosis as pleural metastasis of BRAFV600E mutated melanoma….Although melanoma treatment was changed to PD-1 and CTLA-4 combination blockade with nivolumab (80mg/body) and ipilimumab (3mg/kg) for second line therapy, and was changed again to BRAF/MEK double blockade with dabrafenib (300mg/day) and trametinib (2mg/day) for third line therapy, she eventually died of respiratory failure due to exacerbation of melanoma lung metastases.
