Novartis phase II GEOMETRY mono-1 trial of investigational medicine capmatinib (INC280) shows positive results in patients with MET mutated advanced NSCLC - Seite 2

"Patients diagnosed with advanced MET mutated NSCLC represent an unmet medical need and often face a poor prognosis," said Samit Hirawat, MD, Head, Novartis Oncology Global Drug Development. "We are encouraged by the GEOMETRY mono-1 results and the potential for capmatinib to help patients with this disease."

About GEOMETRY mono-1
The GEOMETRY mono-1 trial is a multicenter, open-label, phase II study to evaluate the efficacy and safety of single-agent INC280 in adult patients with EGFR wildtype, ALK-negative rearrangement, advanced NSCLC harboring MET amplification and/or mutations. Patients with MET exon-14 skipping were assigned to Cohorts 4 (previously treated patients) or 5B (treatment naive) regardless of MET amplification/gene copy number (centrally confirmed), and received 400 mg capmatinib tablets twice daily. The primary endpoint was ORR based on BIRC assessment per RECIST v1.1. The key secondary endpoint was duration of response (DOR) by BIRC. The GEOMETRY mono-1 study found an ORR in the treatment-naive patients (n=25) of 72.0% (95% CI: 50.6-87.9) and an ORR in the previously treated patients (n=69) of 39.1% (95% CI: 27.6-51.6). DOR was not reached by the time of analysis, indicating sustainability of response[1],[6]. 

The most common treatment-related AEs included peripheral edema, nausea, vomiting, and increased blood creatinine levels. Of patients treated with INC280, 83.8% experienced an AE, with 33.1% having grade 3/4 AEs[1],[6].

Capmatinib (INC280) is an investigational, oral and selective MET inhibitor licensed to Novartis by Incyte Corporation in 2009. Under the Agreement, Incyte granted Novartis exclusive Development and Commercialization worldwide rights to this MET inhibitor compound and certain back-up compounds in all indications.

Novartis Commitment to Lung Cancer
Worldwide, lung cancer causes more deaths than colon, breast and prostate cancer combined, and over 2 million new cases of lung cancer are diagnosed each year[2]. Among patients with NSCLC, almost 70% have an actionable mutation that may be targeted with available therapies[7]. To determine the most appropriate treatment, medical organizations recommend genomic testing for patients with lung cancer[8].

Novartis Oncology's research in NSCLC has helped transform treatment approaches for patients living with mutation-driven diseases, among others. Novartis continues its commitment to the global lung cancer community through ongoing studies, as well as the exploration of investigational compounds that target genetic biomarkers in NSCLC.