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Gregory J. Riely, MD, PhD
Gregory J. Riely, MD, PhD
Posted: Wednesday, September 18, 2024
The PHAROS study, conducted by Gregory J. Riely, MD, PhD, of Memorial Sloan Kettering Cancer Center, New York, and colleagues, evaluated the efficacy and safety of the kinase inhibitor encorafenib combined with the MEK1/2 inhibitor binimetinib in patients with BRAF V600E–mutant, metastatic non–small cell lung cancer (NSCLC). The updated results after 18 months of additional follow-up were presented during the European Society for Medical Oncology (ESMO) Congress 2024 (Abstract LBA56).
“The primary endpoint was met, with an objective response rate by independent review radiology of 75% in treatment-naive and 46% in previously treated patients,” stated the researchers about this combination’s U.S. Food and Drug Administration approval. “After an additional 18 months of follow-up, encorafenib plus binimetinib showed prolonged efficacy, especially in treatment-naive patients, with a manageable safety profile in patients with BRAF V600E–mutant metastatic NSCLC.”
This single-arm, open-label, ongoing phase II study enrolled a total of 98 patients with BRAF V600E–mutated NSCLC who received a maximum of one prior systemic therapy. Participants received 450 mg of once-daily encorafenib and 45 mg of twice-daily binimetinib.
The median follow-up was 33.3 months. Of 59 patients who were treatment-naive, 11 remained on treatment; 4 of 39 patients who received prior therapy remained on treatment. The median duration of treatment for those with no or one prior therapy was 16.3 and 5.5 months, respectively. Additionally, the median duration of response was 40.0 months among those who were treatment-naive.
Among participants who had no prior systemic treatment, the median progression-free survival rate was 30.2 months, and the median overall survival rate was not estimable. The most common treatment-related adverse events were fatigue, diarrhea, and nausea in both patient populations. Of note, the safety profile of this drug combination appeared to be similar to that observed in the primary analysis.
Disclosure: For full disclosures of the study authors, visit cslide.ctimeetingtech.com.
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