Phase 2 GEOMETRY mono-1 Trial of Investigational Medicine Capmatinib Shows Positive Results in Patients with MET-mutated Advanced NSCLC
- Phase 2 study efficacy data showed overall response rate of 72.0 percent and 39.1 percent, 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
Novartishas exclusive development and commercialization worldwide rights to capmatinib
Results of the
“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
NSCLC is the most common type of lung cancer, impacting more than 2 million people per year.2 Approximately 3-4 percent 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
“We are very pleased to announce these promising, preliminary results
for capmatinib, another investigational medicine invented at
About GEOMETRY mono-1
The GEOMETRY mono-1 trial is a multicenter, open-label, Phase 2 study to evaluate the efficacy and safety of single-agent capmatinib (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 percent (95% CI: 50.6-87.9) and an ORR in the previously treated patients (n=69) of 39.1 percent (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 capmatinib, 83.8 percent experienced an AE, with 33.1 percent having grade 3/4 AEs.1,6
Capmatinib (INC280) is an investigational, oral and selective MET
inhibitor invented at
Except for the historical information set forth herein, the matters set
forth in this press release, including statements regarding the ongoing
clinical development program for capmatinib and its potential in
treating NSCLC, Novartis’ plans to file an NDA for capmatinib and the
expected timing of such filing, and whether and when
These forward-looking statements are based on the Company’s current
expectations and subject to risks and uncertainties that may cause
actual results to differ materially, including unanticipated
developments in and risks related to: unanticipated delays; further
research and development and the results of clinical trials possibly
being unsuccessful or insufficient to meet applicable regulatory
standards or warrant continued development; the ability to enroll
sufficient numbers of subjects in clinical trials; determinations made
Juergen Wolf. Results of the GEOMETRY mono-1 phase II study for evaluation of the MET inhibitor capmatinib (INC280) in patients with METΔex14 mutated advanced non-small cell lung cancer. Abstract #LBA52. 2018 European Society of Medical Oncology( ESMO), October 19-23, 2018, Munich, Germany.
Globocan. Lung Fact Sheet. Available at http://gco.iarc.fr/today/data/factsheets/cancers/15-Lung-fact-sheet.pdf.
October 9, 2018.
- Salgia R. MET in Lung Cancer: Biomarker Selection Based on Scientific Rationale. Mol Cancer Ther. 2017;16(4):555-565.
Tong JH, Yeung SF, Chan AWH, et al. MET Amplification and Exon 14
Splice Site Mutation Define Unique Molecular Subgroups of Non–Small
Cell Lung Carcinoma with Poor Prognosis.
Clin Cancer Res. 2016;22(12):3048-3056.
Lungevity. Targeted Therapy: What is driver mutation? Available at https://lungevity.org/for-patients-caregivers/lung-cancer-101/treatment-options/targeted-therapy.
October 9, 2018.
- A Study of Capmatinib (INC280) in NSCLC Patients With MET Exon 14 Alterations Who Have Received Prior MET Inhibitor. (2016). Retrieved from http://clinicaltrials.gov/ct2 (Identification No. NCT02750215).