Author of

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  OA01 - Precision Medicine and Personalized Therapy for Lung Cancer (ID 1)

  • Event: NACLC 2019
  • Type: Oral Abstract Session
  • Track:
  • Presentations: 1
  • Moderators:
  • Coordinates: 10/11/2019, 14:00 - 15:40, Imperial Ballroom (B2 Level)

  • 33266

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    OA01.07 - Capmatinib (INC280) in METΔex14-mutated Advanced NSCLC: Efficacy Data from the Phase 2 GEOMETRY Mono-1 Study (ID 54)

    14:00 - 15:40  |  Author(s): Harry J. M. Groen
    • Abstract
    • Slides

    Background:
    Capmatinib is a highly potent, selective MET-inhibitor known to cross the BBB, and intracranial activity with capmatinib has been previously reported. Updated results for overall response rate (ORR), duration of response (DOR), progression-free survival (PFS), and brain metastases (BM) activity from the GEOMETRY mono-1 study are presented here.
    
    
    Method:
    GEOMETRY mono-1 is a phase 2, multi-cohort, multicenter study evaluating capmatinib in MET?ex14-mutated or MET-amplified NSCLC patients. Patients (?18 years) with ECOG PS 0–1, ALK-/EGFR-wt, and stage IIIB/IV NSCLC were eligible. Patients with asymptomatic BM were allowed. MET?ex14-mutated patients were assigned to Cohorts 4 (1-2 prior lines of treatment) and 5b (treatment-naive) and received capmatinib 400mg BID. Endpoints by BIRC: ORR (primary, RECIST v1.1), DOR, and PFS. Ad hoc BIRC neuro-radiologic assessments of all Cohort 4 and 5b patients with baseline BM were performed.
    
    
    Results:
    As of April 15, 2019, 97 patients (Cohort 4: 69 patients; Cohort 5b: 28 patients) were evaluable for efficacy. BIRC assessments: ORR (95% CI): 40.6% (28.9-53.1) in Cohort 4; 67.9% (47.6-84.1) in Cohort 5b. Median DOR (95% CI): 9.7 (5.55-12.98) and 11.1 (5.55-NE) months and median PFS (95% CI): 5.4 (4.17-6.97) and 9.7 (5.52-13.86) months for Cohorts 4 and 5b, respectively. Of 13 evaluable patients with BM at baseline, 7 (54%) had intracranial response by BIRC, including 4 patients with complete resolution of brain lesions, and 12/13 had intracranial disease control. Responses in the brain were as fast as systemic responses. Most common treatment-related AEs (?15%, all grades) across all cohorts (N=334): peripheral edema (41.6%), nausea (33.2%), increased blood creatinine (19.5%), and vomiting (18.9%); most AEs were grade 1/2.
    
    
    Conclusion:
    These data confirm capmatinib to be a promising new treatment option for patients with MET?ex14-mutated advanced NSCLC regardless of line of therapy, with deep and durable responses including in patients with brain metastases, and a manageable toxicity profile.

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