FDA approves Braftovi-Mektovi combination for lung cancer
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The FDA approved encorafenib plus binimetinib for treatment of certain patients with non-small cell lung cancer.
The indication applies to use of the agent by adults with BRAF V600E-mutant metastatic NSCLC detected by an FDA-approved test.
Encorafenib (Braftovi, Pfizer) is a BRAF inhibitor and binimetinib (Mektovi, Pfizer) is a MEK inhibitor.
The FDA previously approved the combination for treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations.
BRAF V600E mutations are present in approximately 2% of NSCLC cases.
The agency based the new indication on data from the ongoing phase 2 PHAROS trial.
The single-arm, open-label, multicenter study is assessing encorafenib and binimetinib for treatment-naive and previously treated patients with NSCLC who harbor BRAF V600E mutations.
The study met its major efficacy outcome measures — objective response rate per independent review committee assessment and duration of response — for both the treatment-naive and previously treated groups.
Among the 59 treatment-naive patients, researchers reported an ORR of 75% (95% CI, 62-85). More than half (59%) of patients responded for at least 12 months, with median duration of response not estimable at data cutoff.
Among the 39 previously treated patients, researchers reported an ORR of 46% (95% CI, 30-63). One-third (33%) of patients responded for at least 12 months, with median response duration of 16.7 months (95% CI, 7.4 to not estimable).
Adverse events reported among at least 25% of study participants included fatigue, nausea, diarrhea, musculoskeletal pain, vomiting, abdominal pain, visual impairment, constipation, dyspnea, rash and cough.
Adverse reactions prompted 17% of patients to discontinue binimetinib and 16% to discontinue encorafenib.
More than one-third (38%) of trial participants experienced serious adverse reactions. These included hemorrhage (6%), diarrhea (4.1%), anemia (3.1%), dyspnea (3.1%) and pneumonia (3.1%).
Two patients had fatal adverse reactions — one died of intracranial hemorrhage and one died of myocardial infarction.
“BRAF V600E mutations identify a unique subtype of metastatic non-small cell lung cancer that presents an actionable biomarker that precision medicines like [encorafenib and binimetinib] combination therapy can help address,” trial investigator Gregory Riely, MD, PhD, vice chair for clinical research in the department of medicine at Memorial Sloan Kettering Cancer Center, said in Pfizer press release. “The PHAROS trial demonstrated that these patients could benefit from [encorafenib and binimetinib] targeted therapy regardless of their prior treatment history. Given the specific efficacy and safety profile, patients and providers now have another option to help personalize treatment plans based on individual risk factors and preferences.”
The FDA also approved two companion diagnostics for treatment with encorafenib and binimetinib. FoundationOne Liquid CDx (Foundation Medicine) is approved for detecting mutations in plasma samples. FoundationOne CDx (Foundation Medicine) is approved for tissue testing.
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