Pfizer Inc. (PFE) has released extended follow-up findings from the Phase 2, single-arm PHAROS clinical trial that evaluates the efficacy and safety of the drug combination BRAFTOVI (encorafenib) and MEKTOVI (binimetinib) in patients with BRAF V600E-mutant metastatic non-small cell lung cancer (NSCLC).The company reported that, with an additional 18 months of follow-up, the independent radiology review showed an objective response rate (ORR) of 75% and a median duration of response (DoR) of 40 months in treatment-naive patients. For previously treated patients, the ORR was 46% and the median DoR was 16.7 months.Moreover, after approximately three years of follow-up in treatment-naive patients, the median progression-free survival (PFS) with the combination therapy was 30.2 months, while the median overall survival had not yet been reached.The Phase 2 PHAROS trial is an open-label, multicenter, single-arm study investigating the BRAFTOVI + MEKTOVI combination in both treatment-naive and previously treated patients with BRAF V600E-mutant metastatic NSCLC. In previously treated patients with extended follow-up, the combination therapy demonstrated a median PFS of 9.3 months and a median overall survival of 22.7 months. The safety profile remained consistent with previous results, and no new safety concerns were identified.In this analysis, treatment-related adverse events (AEs) prompted dose reductions in 26% of patients and led to permanent discontinuations in 16% of patients. The most common treatment-related AEs were nausea, diarrhea, and fatigue.BRAFTOVI + MEKTOVI received approval from the U.S. Food and Drug Administration (FDA) in October 2023, and from the European Commission in August 2024, for the treatment of BRAF V600E-mutant metastatic NSCLC, based on initial ORR (the primary endpoint) and DoR (a key secondary endpoint) results from the PHAROS clinical trial.The material has been provided by InstaForex Company – www.instaforex.com
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