In the ongoing, multicohort, phase 2 GEOMETRY mono-1 study, Capmatinib ( Tabrecta ) has shown efficacy in METex14–mutated non–small cell lung cancer ( NSCLC ) patients who were pretreated ( cohort 4 ) or treatment-naïve ( cohort 5b ).
Researchers have reported the efficacy and safety of Capmatinib in patients with high-level MET-amplified ( gene copy number [ GCN ] greater than or equal to 10 ) advanced NSCLC who were either pretreated with 1 or 2 prior lines of systemic therapy or treatment-naïve.
Adult patients ( greater than or equal to 18 years ), ECOG PS 0–1 who had ALK and EGFR wild-type, stage IIIB/IV ( any histology ) MET-amplified NSCLC with GCN greater than or equal to 10 received Capmatinib 400 mg twice daily ( fasting ).
Primary and key secondary endpoints were overall response rate ( ORR ) and duration of response ( DOR ), respectively, by blinded independent review committee ( BIRC ) assessment per RECIST v1.1.
Other secondary endpoints included investigator-assessed ORR, DOR, disease control rate ( DCR ), progression-free survival ( PFS, BIRC and investigator assessment ), overall survival, and safety.
As of Jan 06, 2020, 84 patients were evaluable for efficacy ( cohort 1a [ 2nd/3rd line ], 69 pts; Cohort 5a [ 1st line ], 15 pts ).
Treatment was ongoing for 3 patients in cohort 1a, none in cohort 5a.
Per BIRC assessment in cohorts 1a and 5a, respectively, ORR was 29% and 40%, median DOR was 8.31 months ( 20 responders, 95% CI: 4.17–15.44 ) and 7.54 months ( 6 responders, 95% CI: 2.56–14.26 ), and median PFS was 4.07 ( 95% CI: 2.86–4.83 ) and 4.17 ( 95% CI: 1.45–6.87 ) months.
Investigator assessment was in line with BIRC assessment.
The most common adverse events across all cohorts ( greater than or equal to 25%, all grades, N = 364 ) were peripheral edema ( 51.1% ), nausea ( 44.8% ) and vomiting ( 28.0% ).
In conclusion, Capmatinib has demonstrated activity in the subset of patients with high-level MET-amplified ( GCN greater than or equal to10 ) NSCLC, with a higher response rate in treatment-naïve patients.
Safety profile remains favorable and similar to previous reports of Capmatinib. ( Xagena )
Source: American Society of Clinical Oncology ( ASCO ) Virtual Meeting, 2020