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

Novartis International AG / Novartis phase II GEOMETRY mono-1 trial of investigational medicine capmatinib (INC280) shows positive results in patients with MET mutated advanced NSCLC . Processed and transmitted by West Corporation. The issuer is solely responsible for the content of this announcement.

• Phase II study efficacy data showed overall response rate of 72.0% and 39.1%, respectively, in treatment-naive and previously treated patients with advanced MET exon-14 skipping mutated non-small cell lung cancer (NSCLC)
   

Clinical findings from ongoing study indicate safety profile was consistent with previously reported data results 
 

Capmatinib, an investigational MET inhibitor, may have the potential to improve response rates for people diagnosed with MET exon-14 skipping mutated NSCLC, a known oncogenic driver

Basel, October 19, 2018 - Novartis today announced Phase II preliminary results of the GEOMETRY mono-1 clinical trial of investigational MET inhibitor capmatinib (INC280) in 94 adult patients with advanced non-small cell lung cancer (NSCLC) harboring MET exon-14 skipping mutations. The GEOMETRY mono-1 study showed an overall response rate (ORR) of 72.0% (95% CI: 50.6-87.9) in treatment-naive patients and 39.1% (95% CI: 27.6-51.6) in previously treated patients. ORR was assessed by blinded independent review committee (BIRC). Adverse events (AEs) were consistent with previously reported data and no new safety signals were observed. Results of the Phase II study were presented today at the European Society for Medical Oncology (ESMO) 2018 Congress [October 19, 2018 at 4:45 PM CET] (Abstract #LBA52)[1].

"These preliminary findings reveal the potential of capmatinib in MET exon-14 skipping mutated NSCLC patients. Compared to the previously treated patient groups, the primary advantage in terms of overall response rate reported in treatment-naive patients highlights the clinical relevance for an earlier diagnostic testing and prompt treatment of this challenging patient population," said Juergen Wolf, MD, University Hospital Cologne.

NSCLC is the most common type of lung cancer, impacting more than 2 million people per year[2]. Approximately 3-4% of all patients with NSCLC have an identified MET mutation[3]. Though rare, this mutation is an indicator of especially poor prognosis and there is currently no approved therapy designed to target this mutation[4].