2019 ASCO Annual Meeting!
Session: Lung Cancer—Non-Small Cell Metastatic
Type: Oral Abstract Session
Time: Monday June 3, 8:00 AM to 11:00 AM
Location: Hall B1
Capmatinib (INC280) in METΔex14-mutated advanced non-small cell lung cancer (NSCLC): Efficacy data from the phase II GEOMETRY mono-1 study.
Metastatic Non-Small Cell Lung Cancer
Lung Cancer—Non-Small Cell Metastatic
2019 ASCO Annual Meeting
J Clin Oncol 37, 2019 (suppl; abstr 9004)
Author(s): Juergen Wolf, Takashi Seto, Ji-Youn Han, Noemi Reguart, Edward B. Garon, Harry J.M. Groen, Daniel Shao-Weng Tan, Toyoaki Hida, Maja J. De Jonge, Sergey V. Orlov, Egbert F. Smit, Pierre Jean Souquet, Johan F. Vansteenkiste, Monica Giovannini, Sylvie Le Mouhaer, Anna Robeva, Maeve Waldron-Lynch, Rebecca Suk Heist; Lung Cancer Group Cologne, University of Cologne, Faculty of Medicine and University Hospital of Cologne, Dept. for Internal Medicine, Cologne, Germany; National Kyushu Cancer Center, Fukuoka, Japan; National Cancer Center, Gyeonggi-Do, South Korea; University Hospital Clinic of Barcelona, Barcelona, Spain; University of California, Los Angeles, Los Angeles, CA; Dept. of Pulmonary Diseases - University of Groningen and University Medical Center Groningen, Groningen, Netherlands; National Cancer Center, Singapore, Singapore; Aichi Cancer Center, Nagoya, Japan; Erasmus MC Cancer Institute, Rotterdam, Netherlands; St. Petersburg Pavlov State Medical University, St. Petersburg, Russia; Netherlands Cancer Institute, Amsterdam, Netherlands; University Hospital of Lyon-Sud, Lyon, France; Gasthuisberg University Hospital, Leuven, Belgium; Novartis Pharmaceuticals Corporation, East Hanover, NJ; Novartis Pharma S.A.S, Paris, France; Novartis Pharma AG, Basel, Switzerland; Massachusetts General Hospital Cancer Center, Boston, MA
Background: Capmatinib is a highly potent and selective MET inhibitor. Previous data of GEOMETRY mono-1 study showed a clinically meaningful overall response rate (ORR) and manageable toxicity profile in patients (pts) with METΔex14–mutated NSCLC who received 1–2 prior lines of treatment (tx) (Cohort 4) and in particular a high ORR in tx-naïve pts (Cohort 5b). Here we report the results in METΔex14–mutated NSCLC for duration of response (DOR) and progression-free survival (PFS) as well as the updated results for ORR. Methods: GEOMETRY mono-1 is a phase 2, multi-cohort, multicenter study evaluating capmatinib in pts with METΔex14-mutated or MET-amplified advanced NSCLC across 6 cohorts. Pts (≥18 yrs) with ECOG PS 0–1, ALK and EGFR wt, and stage IIIB/IV NSCLC were eligible. Pts with METΔex14 mutation (centrally confirmed) were assigned (regardless of MET amplification status/gene copy number) to Cohorts 4 and 5b and received capmatinib tablets 400 mg BID. Primary endpoint was ORR by Blinded Independent Review Committee (BIRC) per RECIST v1.1. Key secondary endpoint was DOR by BIRC. Results: As of Nov 08, 2018, 97 pts with METΔex14-mutated NSCLC (Cohort 4: 69 pts; Cohort 5b: 28 pts) were evaluable for efficacy. ORR (95% CI) by BIRC was 39.1% (27.6-51.6) in Cohort 4 and 71.4% (51.3-86.8) in Cohort 5b. While still immature at the time of this analysis, data on durability are promising: median DOR (95% CI) by BIRC was 9.72 (4.27-11.14) and 8.41 (5.55-NE) mo for Cohorts 4 and 5b, respectively; median PFS (95% CI) by BIRC was 5.42 (4.17-6.97) and 9.13 (5.52-13.86) mo for Cohorts 4 and 5b, respectively. Safety profile remains favourable and unchanged. Most common AEs (≥25% all grades) across all cohorts (n = 315), were peripheral edema (49.2%), nausea (43.2%), and vomiting (28.3%); majority of the AEs were grade 1/2. Final efficacy analysis (12-mo f-u on DOR) including biomarker data will be presented during meeting. Conclusions: These data confirm capmatinib to be a promising new treatment option for pts with METΔex14-mutated advanced NSCLC regardless of the line of therapy with deep and durable responses and manageable toxicity profile. Clinical trial information: NCT02414139