October 12, 2023 – New York – (Business Wire)
Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has approved Braftovi® (encorafenib) in combination with Mektovi® (binimetinib) for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. The BRAF V600E mutation can be assessed using the FDA-approved companion diagnostic tests: FoundationOne Liquid CDx (plasma specimens) or FoundationOne CDx (tumor tissue specimens).
Chris Boshoff, MD, PhD, Chief Oncology Research and Development Officer and Executive Vice President at Pfizer, stated: "Today’s approval builds upon our long-standing commitment to delivering innovative, personalized medicines to patients with lung cancer. By pursuing precision medicines that target specific cancer types in patients, we are leveraging our deep expertise in oncology biology to help address the underlying causes of the disease. Since its initial FDA approval in 2018, the Braftovi + Mektovi combination therapy has helped thousands of patients with unresectable or metastatic melanoma harboring BRAF V600E or V600K mutations.² We look forward to helping even more patients through our targeted combination therapy of binimetinib and encorafenib."
The FDA’s approval is based on data from the ongoing Phase 2 PHAROS clinical trial (NCT03915951). This trial is an open-label, multicenter, single-arm study designed to evaluate the efficacy of the binimetinib + encorafenib combination therapy in patients with metastatic NSCLC harboring a BRAF V600E mutation who are either treatment-naïve (untreated) or previously treated. Gregory Riely, MD, PhD—Vice Chair of Clinical Research in the Department of Medicine at Memorial Sloan Kettering Cancer Center (MSK) and an investigator in the PHAROS trial—stated: "The BRAF V600E mutation defines a distinct subtype of metastatic non-small cell lung cancer, presenting a targetable biomarker that precision medicines—such as the combination therapy of Binimetinib and Encorafenib—can help address. The PHAROS trial demonstrates that these patients may benefit from targeted therapy with Binimetinib and Encorafenib, regardless of their prior treatment history. Given its specific efficacy and safety profile, patients and healthcare providers now have an additional option to help formulate individualized treatment plans based on individual risk factors and preferences."
Safety
The most common (≥25%) all-cause adverse reactions observed in the PHAROS trial included: fatigue, nausea, diarrhea, musculoskeletal pain, vomiting, abdominal pain, vision disorders, constipation, dyspnea, rash, and cough. In total, 17% of patients permanently discontinued Mektovi due to adverse reactions, and 16% of patients permanently discontinued Braftovi due to adverse events. Serious adverse reactions occurred in 38% of patients. Serious adverse reactions occurring at an incidence rate of ≥2% included: hemorrhage (6%), diarrhea (4.1%), anemia, dyspnea, and pneumonia (3.1% each); and arrhythmia, device-related infection, edema, myocardial infarction, and pleural effusion (2% each). Fatal adverse reactions occurred in 2% of patients, including intracranial hemorrhage and myocardial infarction (1% each).
The Binimetinib and Encorafenib combination therapy is also FDA-approved for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. Furthermore, encorafenib has received FDA approval, in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) who harbor a BRAF V600E mutation—as detected by an FDA-approved test—and who have received prior therapy.
