NEW YORK CITY (dpa-AFX) - 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.
For More Such Health News, visit rttnews.com.
Copyright(c) 2024 RTTNews.com. All Rights Reserved
Copyright RTT News/dpa-AFX
© 2024 AFX News
