The FDA has accepted and granted a Priority Review to a New Drug Application for capmatinib (INC280, Novartis), which is being evaluated as a first-line treatment and in previously treated patients with locally advanced or metastatic MET exon 14 (METex14) skipping mutated non-small cell lung cancer.

Capmatinib is an investigational, oral, and selective MET inhibitor, and if approved, it will be the first therapy to specifically target METex14 mutated advanced lung cancer, according to the company.

The NDA submission for capmatinib is supported by results from the GEOMETRY mono-1 phase 2 study, which demonstrated an overall response of 67.9% and 40.6% among treatment-naïve and previously treated patients, respectively, based on the Blinded Independent Review Committee (BIRC) assessment per RECIST.
 


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The study also demonstrated that capmatinib provided a durable response among all patients. The median duration of response was 11.14 months in treatment-naïve patients and 9.72 months in previously treated patients.

All of the reported results were based on independent assessment by the BIRC, and all tumor CT scans were evaluated in parallel by 2 radiologists to confirm the response.

The most common treatment-related adverse events across all cohorts were peripheral edema, nausea, creatinine increase, vomiting, fatigue, decreased appetite, and diarrhea.

“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,” said John Tsai, MD, head of Global Drug Development and chief medical officer, 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.”

REFERENCE

Novartis announces MET inhibitor capmatinib (INC280), the first potential treatment for METex14 mutated advanced non-small cell lung cancer, granted priority FDA review [news release]. https://www.novartis.com/news/media-releases/novartis-announces-met-inhibitor-capmatinib-inc280-first-potential-treatment-metex14-mutated-advanced-non-small-cell-lung-cancer-granted-priority-fda-review. Published February 11, 2020. Accessed February 11, 2020.