Pfizer Inc. (PFE) announced longer-term follow-up results from the Phase 2 single-arm PHAROS clinical trial evaluating the efficacy and safety of BRAFTOVI (encorafenib) in combination with MEKTOVI (binimetinib) for patients with BRAF V600E-mutant metastatic non-small cell lung cancer (NSCLC).
According to the company, after an additional 18 months of follow-up, the objective response rate (ORR) and the median duration of response (DoR) as assessed by independent radiology review were 75% and 40 months in treatment-naive patients and 46% and 16.7 months in previously treated patients, respectively.
In addition, after approximately three years of follow-up in treatment-naive patients, the median progression-free survival (PFS) with BRAFTOVI + MEKTOVI was 30.2 months, while median overall survival was not yet reached.
The Phase 2 PHAROS trial is an open-label, multicenter, single arm study examining BRAFTOVI + MEKTOVI combination therapy in treatment-naive and previously treated patients with BRAF V600E-mutant metastatic NSCLC. Notably, upon longer-term follow-up in previously treated patients, BRAFTOVI + MEKTOVI showed a median PFS of 9.3 months and a median overall survival of 22.7 months, with a safety profile that was consistent with previous findings; no new safety concerns were identified.
In this analysis, treatment-related adverse events (AEs) led to dose reduction in 26% of patients, and to permanent discontinuation in 16% of patients. Nausea, diarrhea, and fatigue remained the most common treatment-related AEs.
BRAFTOVI + MEKTOVI was approved by the U.S. Food and Drug Administration (FDA) in October 2023, and by the European Commission in August 2024, for the treatment of BRAF V600E-mutant metastatic NSCLC based on the initial ORR (the primary endpoint) and DoR (key secondary endpoint) results from the PHAROS clinical trial.
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