Novartis AG said INC280, or capmatinib, showed promise in a phase 2 clinical trial as a potential treatment for patients with non-small cell lung cancer with a rare mutation.
Results from the Geometry mono-1 study showed that the drug shrank tumors in 68% of patients who had never received treatment and in 41% of previously treated patients, as measured by a metric called overall response rate — the study's main goal.
Over 2 million new cases of lung cancer are diagnosed worldwide each year, and about 3% to 4% of patients with non-small cell lung cancer, or NSCLC, have the MET exon-14 skipping mutation. There is no approved treatment for this form of NSCLC.
Median duration of response, a key secondary goal of the study, came in at 11.14 months and 9.72 months for patients who never received treatment and those who were previously treated, respectively. Median duration of response is the time between the initial response to therapy and disease progression.
Adverse events resulting from the treatments were mild to moderate.
The U.S. Food and Drug Administration recently granted INC280 breakthrough therapy designation for patients with metastatic NSCLC harboring MET exon-14 skipping mutation, whose condition worsened on or after chemotherapy. The agency, along with Japan's Pharmaceuticals and Medical Devices Agency, previously designated capmatinib as an orphan drug.
Wilmington, Del.-based Incyte Corp. granted exclusive global development and commercialization rights for capmatinib to Novartis in 2009.
The 2019 American Society of Clinical Oncology meeting is expected to bring together more than 32,000 professionals from around the world, with more than 2,400 study abstracts to be presented on site and an additional 3,200 abstracts to be published online.