Drug updated on 12/11/2024
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
- This summary is based on the review of nine systematic review(s)/meta-analysis(es). [1-9]
- Lung Cancer Outcomes: In lung cancer, treatments showed a wide range of effectiveness. The Objective Response Rate (ORR) reached up to 75%, while Progression-Free Survival (PFS) extended to 9.3 months. Disease Control Rate (DCR): The pooled DCR for 177Lu-DOTATATE and 90Y-DOTATOC in metastatic pheochromocytomas (PCCs) and paragangliomas (PGLs) after 24 weeks ranged from 41% to 64%, and Overall Survival (OS) varied between 3.0 and 18.8 months.
- Metastatic Melanoma Outcomes: In metastatic melanoma, the combination of Encorafenib and Binimetinib had a higher ORR compared to Dabrafenib and Trametinib (odds ratio (OR) = 1.86). Nivolumab combined with Ipilimumab improved OS and PFS over other treatments, with time-varying analyses showing significant benefits in both outcomes after 12 months compared to BRAF/MEK inhibitors.
- BRAF V600-Mutant Advanced Melanoma: Combination therapies like Dabrafenib + Trametinib demonstrated efficacy comparable to Encorafenib + Binimetinib and Vemurafenib + Cobimetinib. Immunotherapy with Nivolumab and Ipilimumab showed durable improvements in OS and PFS, especially after 12 months, when compared to BRAF/MEK inhibitor regimens.
- Comparison of Drugs: In metastatic melanoma, Encorafenib + Binimetinib showed superior ORR compared to other combinations. In lung cancer, Binimetinib showed no significant efficacy advantage over chemotherapy.
- In lung cancer, over 50% of patients experienced treatment-related adverse events, leading to dose limitations or drug discontinuation. Serious adverse events, such as colitis, febrile neutropenia, and pulmonary infections, were common, with some cases resulting in death due to disease progression.
- In metastatic melanoma, the combination of Encorafenib and Binimetinib had fewer serious adverse events compared to Vemurafenib + Cobimetinib. However, Nivolumab + Ipilimumab had higher rates of Grade 3/4 treatment-related adverse events compared to BRAF/MEK inhibitors.
- Severe Cutaneous Adverse Reactions (SCARs), though rare, were mainly associated with Vemurafenib in BRAF V600-mutant advanced melanoma, requiring close monitoring for conditions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) and Toxic Epidermal Necrolysis (TEN).
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Mektovi (binimetinib) Prescribing Information. | 2023 | Pfizer Inc., New York, NY |
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 | Journal 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 |