Drug updated on 9/4/2024
| Dosage Form | Capsule (oral; 75 mg) |
| Drug Class | Kinase inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- 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.
- Indicated in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy.
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Summary
- Braftovi (encorafenib) is 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. It is also indicated, in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy.
- This summary is based on the review of 12 systematic review(s)/meta-analysis(es). [1-12]
- In colorectal cancer (CRC) patients, the overall response rate (ORR) for those treated with BRAF inhibitor-based regimens was 23%, compared to 2.5% in the control group. Triplet encorafenib therapy showed a significantly improved overall survival (OS) with a hazard ratio (HR) of 0.52 (95% CI: 0.39-0.70). Single-arm trials reported an ORR of 17% for two-drug regimens and 34% for three-drug regimens.
- In metastatic melanoma, the combination of encorafenib + binimetinib was superior to dabrafenib + trametinib (OR = 1.86; 95% CrI: 1.10-3.17) and comparable to atezolizumab + vemurafenib + cobimetinib. Nivolumab + ipilimumab improved overall survival (OS) compared to DAB+TRAM, ENCO+BINI, and VEM+COBI with HRs of 0.53, 0.60, and 0.50 respectively. Additionally, nivolumab + ipilimumab showed significant OS and progression-free survival (PFS) improvements 12 months after treatment initiation compared to BRAF/MEK inhibitors.
- In terms of safety for metastatic melanoma, encorafenib + binimetinib was associated with 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). Vemurafenib was linked to severe cutaneous adverse reactions (SCARs), including DRESS and SJS/TEN. BRAF + MEK inhibitors increased the risk of cardiovascular adverse events (CVAEs), including pulmonary embolism, decreased left ventricular ejection fraction, and arterial hypertension.
- BRAF inhibitor-based regimens for colorectal cancer were generally safe; however, specific adverse events were not detailed.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Braftovi (encorafenib) Prescribing Information. | 2023 | Array BioPharma Inc., Boulder, CO |