FDA Approves Encorafenib Plus Binimetinib for Metastatic BRAF V600E Non-Small Cell Lung Cancer
On October 11, 2023, The US Food and Drug Administration (FDA) approved encorafenib plus binimetinib for adult patients with metastatic non-small cell lung cancer (NSCLC) harboring a BRAF V600E mutation, as detected by an FDA-approved test.
This approval was based on results from the open-label, multicenter, single-arm phase 2 PHAROS trial. In this trial, 98 patients who had not been previously treated with BRAF or MEK inhibitors received 450 mg encorafenib once daily plus 45 mg binimetinib twice daily. The major efficacy outcome measures were objective response rate (ORR) and duration of response (DOR) as assessed by an independent review committee.
At analysis, the ORR among treatment-naïve patients (n = 59) was 75% and median DOR was not estimable. Among previously treated patients (n = 39) the ORR was 46% and median DOR was 16.7 months. The most common adverse events occurring in ≥ 25% of patients included fatigue, nausea, diarrhea, musculoskeletal pain, vomiting, abdominal pain, visual impairment, constipation, dyspnea, rash, and cough.
The FDA has additionally approved FoundationOne CDx (tissue) and FoundationOne Liquid CDx (plasma) as companion diagnostics for encorafenib with binimetinib, noting that tumor tissue should be tested when no mutation is detected in a plasma specimen.
The recommended dose is 450 mg encorafenib once daily orally plus 45 mg binimetinib twice daily orally until disease progression or unacceptable toxicity.
Source:
FDA approves encorafenib with binimetinib for metastatic non-small cell lung cancer with a BRAF V600E mutation. US Food and Drug Administration. Published October 11, 2023. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-encorafenib-binimetinib-metastatic-non-small-cell-lung-cancer-braf-v600e-mutation
