Pfizer reports long-term success of BRAFTOVI and MEKTOVI in lung cancer study

Pfizer Inc. announced the results of a long-term follow-up from the Phase 2 PHAROS clinical trial, which evaluated the combination of BRAFTOVI (encorafenib) and MEKTOVI (binimetinib) for patients with BRAF V600E-mutant metastatic non-small cell lung cancer (NSCLC). The study demonstrated a clinically meaningful response, supporting the combination as a standard treatment option for this patient population. Lung cancer remains the leading cause of cancer-related deaths globally, with NSCLC accounting for 80-85% of cases. The BRAFTOVI + MEKTOVI combination received FDA approval in October 2023 and European Commission approval in August 2024, based on initial results from the PHAROS trial. The trial's primary endpoint was the overall response rate (ORR), while the duration of response (DoR) served as a key secondary endpoint. The findings highlight the importance of targeted therapies in treating specific mutations in lung cancer. In addition to the PHAROS trial, Pfizer is also investigating BRAFTOVI in earlier settings of metastatic colorectal cancer and exploring a next-generation brain-penetrant BRAF inhibitor. The ongoing Phase 3 BREAKWATER study is examining BRAFTOVI in combination with cetuximab and FOLFIRI chemotherapy for previously untreated BRAF V600E-mutant metastatic colorectal cancer, with results to be presented at the upcoming ESMO conference. While the combination therapy shows promise, safety information indicates potential risks, including cardiomyopathy and hemorrhage. Serious adverse reactions were reported in 38% of patients receiving the combination, emphasizing the need for careful monitoring and management of side effects in clinical practice.