FDA approves Encorafenib with Binimetinib for metastatic non-small cell lung cancer.


On October 11, 2023, the U.S. Food and Drug Administration granted approval to Encorafenib (BRAF inhibitor) with Binimetinib (MEK inhibitor) for patients with metastatic non-small cell lung cancer (NSCLC) that was detected to have BRAF V600E mutation using a FDA approved test. This approval came right after the approval of the foundation one cdx (tissue) and Foundation one Liquid cdx (plasma) as companion diagnostics for Encorafenib with Binimetinib. If no mutation is detected in a plasma specimen, the tumor tissue should be tested.


Study ID number: NCT03915951


Approval was based on PHAROS trial, a phase 2 multicenter, single-arm study trial that included 98 patients with histologically confirmed diagnosis of NSCLC that is currently stage IV harboring a BRAF V600E mutation. These patients included treatment-naïve (59) or have received first-line platinum-based chemotherapy or an anti-PD-1/PD-L1 inhibitor or both (39). Patients received Encorafenib – 450 mg once daily with Binimetinib – 45 mg twice daily in a 28-day cycle.


The primary efficacy outcome was objective response rate (ORR). In treatment-naïve previously treated patients, ORR was 75% (95% CI: 62, 85) and 46% (95% CI: 30, 63). The median duration of response (DOR), a secondary endpoint was 16.7 months (95% CI: 7.4, NE). The most common adverse reactions (≥25%) were fatigue, nausea, diarrhea, musculoskeletal pain, vomiting, abdominal pain, visual impairment, Constipation, dyspnea, rash, and cough.


Overall, this ongoing trial of Encorafenib plus Binimetinib in patients with BRAF V600E- mutant metastatic NSCLC, showed substantial antitumor activity in this patient population.


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