FDA has granted Priority Review to capmatinib’s NDA to treat locally advanced or metastatic MET exon 14 skipping (METex14) mutated NSCLC.- Novartis

Novartis announced that the FDA accepted and granted Priority Review to capmatinib’s (INC280) New Drug Application (NDA). Capmatinib is a MET inhibitor being evaluated as a treatment for first-line and previously treated patients with locally advanced or metastatic MET exon 14 skipping (METex14) mutated non-small cell lung cancer (NSCLC). If approved, capmatinib will be the first therapy to specifically target METex14 mutated advanced lung cancer, a type of lung cancer with a particularly poor prognosis. Priority Review is granted to therapies that the FDA determines have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions. This designation shortens the FDA review period following the acceptance of the NDA to six months compared to ten months under Standard Review. Novartis was previously granted Breakthrough Therapy designation for capmatinib. There are currently no approved therapies that specifically target METex14 mutated advanced NSCLC. NSCLC accounts for approximately 85% of lung cancer diagnoses. METex14 mutations occur in 3-4% of newly diagnosed advanced NSCLC cases and is a recognized oncogenic driver. 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 Foundation OneCDx 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. The NDA submission for capmatinib is supported by results from the GEOMETRY mono-1 Phase II study, which demonstrated an overall response rate of 67.9% (95% CI, 47.6 - 84.1)1 and 40.6% (95% CI, 28.9 - 53.1)1 among treatment-naïve and previously treated patients, respectively, based on the Blinded Independent Review Committee (BIRC) assessment per RECIST v1. The study also demonstrated that capmatinib provided durable responses among all patients: median duration of response was 11.14 months (95% CI, 5.55 - NE) in treatment-naïve patients and 9.72 months (95% CI, 5.55 - 12.98) in previously treated patients. All results were based on independent assessment by the BIRC, and all tumor CT scans were evaluated in parallel by two radiologists to confirm the response. The most common treatment-related adverse events (AE) (? 10% all grades) across all cohorts (N=334), were peripheral edema (42%), nausea (33%), creatinine increase (20%), vomiting (19%), fatigue (14%), decreased appetite (13%) and diarrhea (11%). The majority of the AEs were grades 1/21.