Drug updated on 9/4/2024
Dosage Form | Tablet (oral; 15 mg) |
Drug Class | Kinase inhibitors |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- 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.
- Indicated in combination with encorafenib, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test.
Latest News
Summary
- Mektovi (binimetinib) is 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; and is indicated in combination with encorafenib for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test.
- This summary is based on the review of nine systematic reviews/meta-analyses. [1-8]
- Effectiveness in Melanoma: Encorafenib + Binimetinib demonstrated a superior overall response rate (ORR) compared to Dabrafenib + Trametinib (OR = 1.86; 95% CrI 1.10-3.17) and was comparable to Atezolizumab + Vemurafenib + Cobimetinib for other efficacy endpoints. Nivolumab + Ipilimumab showed improved overall survival (OS) compared to Encorafenib + Binimetinib (HR = 0.60; 95% CI 0.42-0.85) and was more effective than BRAF/MEK inhibitors in long-term outcomes.
- Progression-Free Survival (PFS) in Melanoma: Both Encorafenib + Binimetinib and Dabrafenib + Trametinib had similar PFS outcomes, with no statistically significant differences in OS, PFS, or ORR when compared indirectly to other BRAF/MEK inhibitors. Nivolumab + Ipilimumab, however, showed better PFS compared to BRAF/MEK inhibitors after 12 months of treatment.
- Effectiveness in BRAF V600E-Mutant Metastatic Colorectal Cancer (mCRC): Encorafenib combined with Cetuximab, with or without Binimetinib, significantly extended OS compared to irinotecan/FOLFIRI plus cetuximab, highlighting its effectiveness in this specific population.
- Safety Profile: Encorafenib + Binimetinib demonstrated fewer serious adverse events (SAEs) compared to Vemurafenib + Cobimetinib (OR = 0.51; 95% CrI 0.29-0.91) and Atezolizumab + Vemurafenib + Cobimetinib (OR = 0.41; 95% CrI 0.21-0.82). Additionally, there were fewer discontinuations due to adverse events with Encorafenib + Binimetinib compared to Vemurafenib + Cobimetinib (OR = 0.45; 95% CrI 0.21-0.96).
- Comparative Toxicity: Combination BRAF + MEK inhibitors, including Encorafenib + Binimetinib, were associated with a higher risk of cardiovascular adverse events (CVAEs) compared to BRAF inhibitor monotherapy, while immunotherapies generally had better acceptability for adverse events compared to targeted therapies.
- Subgroup Findings: Patients with BRAF V600E/K mutant melanoma and metastatic colorectal cancer (mCRC) were the primary focus, with age-related risks identified, such as a significantly higher risk of decreased left ventricular ejection fraction in patients younger than 55 years (RR, 26.50; 95% CI, 3.58-196.10; P = .001), and an increased risk of pulmonary embolism associated with longer follow-up times (mean follow-up >15 months, RR, 7.70; 95% CI, 1.40-42.12; P = .02).
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Mektovi (binimetinib) Prescribing Information. | 2023 | Array BioPharma Inc., Boulder, CO |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of melanoma, version 3.0. | 2023 | Journal of Immunotherapy of Cancer |
Systemic therapy for melanoma: ASCO guideline. | 2020 | American Society of Clinical Oncology |
SEOM clinical guideline for the management of cutaneous melanoma (2020). | 2020 | Clinical and Translational Oncology |
European consensus-based interdisciplinary guideline for melanoma. Part 2: Treatment – update 2019. | 2020 | European Journal of Cancer |