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Proffered paper session - NSCLC, metastatic

2110 - Results of the GEOMETRY mono-1 phase II study for evaluation of the MET inhibitor capmatinib (INC280) in patients (pts) with METΔex14 mutated advanced non-small cell lung cancer (NSCLC)

Date

19 Oct 2018

Session

Proffered paper session - NSCLC, metastatic

Presenters

Juergen Wolf

Authors

J. Wolf1, T. Seto2, J. Han3, N. Reguart4, E.B. Garon5, H.J.M. Groen6, D.S.W.S. Tan7, T. Hida8, M.J.A. de Jonge9, S.V. Orlov10, E.F. Smit11, P. Souquet12, J.F. Vansteenkiste13, M. Giovannini14, S. Le Mouhaer15, A. Robeva16, M. Waldron-Lynch17, R.S. Heist18

Author affiliations

  • 1 Department Of Internal Medicine, University Hospital Cologne, D-50937 - Cologne/DE
  • 2 Department Of Thoracic Oncology, National Kyushu Cancer Center, Fukuoka/JP
  • 3 Center For Lung Cancer, National Cancer Center, 10408 - Gyeonggi-do/KR
  • 4 Medical Oncology Department, University Hospital Clinic of Barcelona, Barcelona/ES
  • 5 Medicine; Division Of Heme/onc, UCLA Hematology/Oncology Santa Monica, 90404 - Santa Monica/US
  • 6 University Medical Center Groningen, University of Groningen and Department of Pulmonary Disease, 9700 RB - Groningen/NL
  • 7 Division Of Medical Oncology, National Cancer Center, 16910 - Singapore/SG
  • 8 Department Of Thoracic Oncology, Aichi Cancer Center, Nagoya/JP
  • 9 Department Of Pulmonology, Erasmus MC Daniel den Hoed Cancer Center, 3075 EA - Rotterdam/NL
  • 10 Department Of Thoracic Oncology, St Petersburg Pavlov State Medical University, St.Petersburg/RU
  • 11 Department Of Pulmonary Diseases, The Netherlands Cancer Institute, 1060NN - Amsterdam/NL
  • 12 Department Of Chest Medicine, University Hospital of Lyon-Sud, 69495 - Pierre Bénite/FR
  • 13 Respiratory Oncology Unit (pulmonology), University Hospitals Leuven, 3000 - Leuven/BE
  • 14 Oncology, Novartis Pharmaceuticals Corporation, 07906 - East Hanover/US
  • 15 Biostatistics, Novartis Pharma S.A.S, Rueil-Malmaison/FR
  • 16 Oncology, Novartis Pharmaceuticals Corporation, East Hanover/GB
  • 17 Oncology, Novartis Pharma AG, Basel/CH
  • 18 Department Of Medicine, Massachusetts General Hospital, 2114 - Boston/US
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Abstract 2110

Background

MET mutations leading to exon 14 deletion (METΔex14) occur in 3-4% of NSCLCs. Capmatinib is a highly potent and selective MET inhibitor. GEOMETRY mono-1 is a phase II, multi-cohort, multicenter study (NCT02414139) evaluating capmatinib in pts with METΔex14 mutated or MET amplified advanced NSCLC. Here we present data from pts with METΔex14 mutation who received either 1–2 prior lines of therapy (Cohort 4) or were treatment-naive (Cohort 5b).

Methods

Eligible pts were ≥18 years of age, ECOG PS 0–1 and had ALK and EGFR wt, stage IIIB/IV NSCLC (any histology). Pts with METΔex14 mutation (centrally confirmed) were assigned to Cohorts 4 and 5b regardless of MET amplification status/gene copy number and received capmatinib tablets 400 mg twice daily. The primary endpoint was overall response rate (ORR) by BIRC per RECIST v1.1. The key secondary endpoint was duration of response (DOR) by BIRC.

Results

As of 9-Aug-2018, 94 pts with METΔex14 mutated advanced NSCLC had ≥18 weeks of follow-up (or discontinued earlier) and were included in this analysis (Cohort 4: 69 of 69 pts in 2nd or 3rd line; Cohort 5b: 25 of 28 treatment-naive pts). Treatment was ongoing for 20.3% and 44.0% of pts in Cohorts 4 and 5b, respectively. ORR by BIRC assessment was 39.1% (95% CI, 27.6-51.6) in cohort 4 and 72.0% (95% CI, 50.6-87.9) in cohort 5b. All responses were confirmed. DOR data is not mature with a median duration of follow-up of 5.6 months. Preliminary activity in patients with brain metastases was also observed. The most common AEs (≥ 20% all grades) across all cohorts (1-6, n=302), regardless of causality, were peripheral edema (49.0%), nausea (43.4%), vomiting (28.5%), blood creatinine increased (24.5%), dyspnea (24.2%), decreased appetite (21.2%) and fatigue (20.9%). Majority of these AEs was grade 1/2.

Conclusions

Capmatinib has demonstrated a clinically meaningful response rate and a manageable toxicity profile in pts with METΔex14 mutated NSCLC, particularly in treatment naive pts where the ORR by BIRC is 72%. Differential benefit from 1L to pretreated pts seem to highlight the need for earlier diagnostic testing and prompt treatment of this challenging patient population.

Clinical trial identification

EudraCT: 2014-003850-15; NCT02414139. Release date 13-Feb-2018.

Editorial Acknowledgement

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