Drug updated on 9/4/2024
Dosage Form | Tablet (oral; 20 mg) |
Drug Class | Kinase inhibitors |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib.
- Indicated for the treatment of adult patients with histiocytic neoplasms, as a single agent.
Latest News
Summary
- Cotellic (cobimetinib) is indicated for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib, and for the treatment of adult patients with histiocytic neoplasms as a single agent.
- This summary is based on the review of nine systematic review(s)/meta-analysis(es). [1-9]
- Encorafenib + binimetinib demonstrated a superior overall response rate (OR = 1.86; 95% CrI 1.10, 3.17) compared to dabrafenib + trametinib in patients with BRAF V600-mutated metastatic melanoma.
- Dabrafenib + trametinib showed comparable progression-free survival (PFS) to encorafenib + binimetinib and vemurafenib + cobimetinib, with hazard ratios for PFS favoring dabrafenib + trametinib (HR = 0.21) and vemurafenib + cobimetinib (HR = 0.22).
- Nivolumab + ipilimumab improved overall survival (OS) compared to dabrafenib + trametinib (HR = 0.64; 95% CI 0.46-0.89) and vemurafenib + cobimetinib (HR = 0.56; 95% CI 0.36-0.89) in the same population.
- Dabrafenib + trametinib demonstrated superior acceptability in terms of any-grade adverse events, with a relative risk (RR) of 0.94 (CrI: 0.89, 0.98) compared to vemurafenib + cobimetinib.
- Severe (Grade 3/4) adverse events were reported in 54.1% of patients receiving nivolumab + ipilimumab, 31.6% with dabrafenib + trametinib, and 59.5% with vemurafenib + cobimetinib.
- Studies focused on patients with BRAF V600-mutant melanoma identified baseline LDH, disease stage, Eastern Cooperative Oncology Group performance status at progression, and post-progression treatment as significant prognostic factors for post-progression overall survival (ppOS), with patients having normal baseline LDH and stage M1c disease showing the longest ppOS when treated with immunotherapy or targeted therapy.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Cotellic (cobimetinib) Prescribing Information. | 2023 | Genentech USA, Inc., South San Francisco, CA |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
European consensus-based interdisciplinary guideline for melanoma. Part 2: Treatment - Update 2022. | 2022 | European Journal of Cancer |
Clinical practice guideline on melanoma from the Spanish Academy of Dermatology and Venereology (AEDV). | 2021 | Actas Dermo-Sifiliográficas |
European consensus-based interdisciplinary guideline for melanoma. Part 2: Treatment – Update 2019. | 2020 | European Journal of Cancer |
Systemic therapy for melanoma: ASCO guideline. | 2020 | Journal of Clinical Oncology |