According to updated data from the phase 2 PHAROS trial, for patients with BRAF V600E-mutant metastatic non-small cell lung cancer (NSCLC), encorafenib plus binimetinib showed prolonged efficacy, particularly among treatment-naïve patients.

These results were first presented by Gregory J. Riely, MD, Memorial Sloan Kettering Cancer Center, New York, New York, at the 2024 European Society for Medical Oncology (ESMO) Congress.

In the ongoing, open-label, single-arm PHAROS trial, 98 patients, who were either treatment-naïve or had received 1 prior systemic therapy, with BRAF V600E-mutant metastatic NSCLC were enrolled. Patients received 450 mg encorafenib daily and 45 mg binimetinib twice daily. The primary end point was overall response rate as assessed by investigators, and was met, with an ORR by independent radiology review of 75% in treatment-naïve patients and 46% in previously treated patients. In 2023, the FDA approved encorafenib-binimetinib for patients in this population based on this data.

With 18 months of additional follow-up, the ORR was 75% among treatment-naïve patients and 46% among previously treated patients. At the time of data cutoff, 11 of 59 treatment-naïve patients (19%) and 4 of 39 previously treated patients (10%) remained on treatment. The median duration of response was 40.0 months and 16.7 months respectively. The median progression-free survival among treatment-naïve patients was 30.2 months and 9.3 months among previously treated patients. The median overall survival was not evaluable and 22.7 months, respectively.

Dr Riely et al concluded that after an additional 18 months of follow-up, the combination of encorafenib and binimetinib “showed prolonged efficacy, especially in treatment-naïve [patients], with a manageable safety profile” among patients with BRAF-V600E-mutant metastatic NSCLC.

Source:

Riely GJ, Ahn M-J, Clarke J, et al. Updated efficacy and safety from the phase II PHAROS study of encorafenib plus binimetinib in patients with BRAF V600E-mutant metastatic NSCLC (mNSCLC). Presented at the 2024 ESMO Congress. September 13-17, 2024; Barcelona, Spain. Abstract: LBA56.