FDA Approves Pfizer’s BRAFTOVI + MEKTOVI in NSCLC

Pfizer received approval from the U.S. FDA for BRAFTOVI (encorafenib) + MEKTOVI (binimetinib) for the treatment of metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. BRAF V600E mutations can be assessed from either plasma or tumor tissue using the FoundationOne Liquid CDx or the FoundationOne CDx FDA-approved companion diagnostic tests, respectively.
 
The FDA’s approval is based on data from the ongoing Phase 2 PHAROS clinical trial (NCT03915951), an open-label, multicenter, single‑arm study examining BRAFTOVI + MEKTOVI combination therapy in both treatment-naïve and previously treated patients with BRAF V600E-mutant metastatic NSCLC.
 
The PHAROS study met its major efficacy outcome measures of objective response rate (ORR), and duration of response (DOR) in both treatment groups. For treatment-naïve patients, ORR was 75%, and 59% of the patients responded for at least 12 months. Median DOR was not estimable for this group. For previously treated patients, ORR was 46%, and 33% of the patients responded for at least 12 months. 
 
The most common adverse reactions observed in the PHAROS trial were fatigue, nausea, diarrhea, musculoskeletal pain, vomiting, abdominal pain, visual impairment, constipation, dyspnea, rash, and cough.