NEW YORK, October 20, 2025 — Pfizer Inc. (NYSE: PFE) today announced updated follow-up results from the single-arm Phase 2 PHAROS trial evaluating BRAFTOVI® (encorafenib) + MEKTOVI® (binimetinib) for the treatment of adults with metastatic non-small cell lung cancer (mNSCLC) with a BRAF V600E mutation. In treatment-naïve patients, the median overall survival (OS) was 47.6 months (95% confidence interval [CI], 31.3, not estimable) after a median follow-up of 52.3 months. In previously treated patients, the median OS was 22.7 months (95% CI, 14.1, 32.6), after a median follow-up of 48.2 months. The four-year OS rates were 49% (95% CI, 35, 62) and 31% (95% CI, 16, 47) for treatment-naïve and previously treated patients, respectively. These data, from pre-specified secondary trial endpoints, will be presented today in an oral presentation (1849MO) at the 2025 European Society for Medical Oncology (ESMO) Congress in Berlin, Germany, and have been simultaneously published in the Journal of Clinical Oncology.
“The PHAROS trial results set a new standard for NSCLC patients with the BRAF V600E mutation, with survival outcomes nearing four years—the longest survival we’ve seen in people with treatment-naïve metastatic NSCLC who harbor a BRAF V600E mutation,” said Melissa Johnson, M.D., Director of Lung Cancer Research at Sarah Cannon Research Institute and PHAROS investigator. “These findings, which highlight the potential impact of encorafenib and binimetinib for newly diagnosed metastatic NSCLC patients with BRAF V600E, offer renewed optimism for their prognosis and treatment goals.”
Lung cancer is the number one cause of cancer-related deaths around the world.1 NSCLC accounts for approximately 80-85% of lung cancers,2 with BRAF V600E mutations occurring in about 2% of patients with NSCLC.3 Prior to the development of targeted treatments, patients with BRAF V600E-mutant metastatic NSCLC had poor outcomes with standard chemotherapy.4
At the time of this analysis, the safety profile of BRAFTOVI + MEKTOVI was consistent with previous findings. The most common (≥30%) treatment-related adverse events were nausea (52%), diarrhea (44%), fatigue (33%), and vomiting (30%).
“These long-term survival results reinforce Pfizer’s unwavering commitment to improving outcomes in lung cancer,” said Jeff Legos, Chief Oncology Officer, Pfizer. “The findings provide hope for treatment-naïve BRAF V600E mNSCLC patients and their families and underscore the importance of advancing therapies that can provide a sustained impact for patients.”
The Phase 2 PHAROS trial (NCT03915951) is an open-label, multicenter, single-arm study examining BRAFTOVI + MEKTOVI combination therapy in treatment-naïve and previously treated patients with BRAF V600E-mutant metastatic NSCLC. 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 objective response rate (ORR; the primary endpoint) and duration of response (secondary endpoint) results from the PHAROS trial. The ORR was 75% (95% CI: 62, 85) for treatment-naïve patients (n=59) and 46% (95% CI: 30, 63) for previously treated patients (n=39).
Pfizer is continuing its commitment to help non-scientists understand the latest findings with the development of abstract plain language summaries (APLS) for company-sponsored research being presented, which are written in non-technical language.