FDA granted Priority Review to a therapy that will be the first to specifically target MET exon 14 (METex14) mutated advanced lung cancer, a lung cancer with a particularly poor prognosis.
INC280 (capmatinib, Novartis) is a MET inhibitor being evaluated as a treatment for first-line and previously treated patients with locally advanced or metastatic METex14 skipping mutated non-small cell lung cancer (NSCLC).
NSCLC accounts for approximately 85% of lung cancer diagnoses, and METex14 mutations occur in 3% to 4% of newly diagnosed advanced NSCLC cases, Novartis said in a statement.
“We are extremely encouraged by the FDA’s Priority Review designation for capmatinib, a MET inhibitor that may be a major treatment advance for patients with this particularly aggressive form of lung cancer,” says John Tsai, MD, head of Global Drug Development and chief medical officer at Novartis.
“Results of the GEOMETRY mono-1 trial clearly identify METex14 as an oncogenic driver and we are inspired to bring capmatinib, potentially the first METex14 targeted therapy, to patients and to reimagine medicine and outcomes for people with lung cancer,” Tsai adds.
The GEOMETRY mono-1 phase 2 study demonstrated an overall response rate of 67.9% and 40.6% among treatment-naïve and previously treated patients, respectively.
The study also demonstrated that capmatinib provided durable responses among all patients: the median duration of response was 11.14 months in treatment-naïve patients and 9.72 months in previously treated patients.
As part of the continued collaboration between Novartis and Foundation Medicine, Inc., companion diagnostics for capmatinib are in development for both tumor tissue and liquid biopsies to be included on FoundationOne®CDx and the forthcoming version of Foundation Medicine’s liquid biopsy platform, which is currently under review with the FDA.
Foundation Medicine is a leading provider of comprehensive genomic profiling solutions for patients with advanced cancer, including NSCLC, Novartis said.