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- Title
Intracranial Activity of Tepotinib in Patients with MET Exon 14 (METex14) Skipping Non-- Small-Cell Lung Cancer (NSCLC) Enrolled in VISION.
- Authors
Hill, Rebecca; Leighl, Natasha; Bestvina, Christine; Patel, Jyoti; Xiuning Le; Veillon, Remi; Anderson, Ian; Demedts, Ingel; Garassino, Marina Chiara; Mazières, Julien; Morise, Masahiro; Smit, Egbert; Eggleton, S. Peter; O'Brate, Aurora; Bruns, Rolf; Adrian, Svenja; Paik, Paul K.
- Abstract
Background: Brain metastases (BMs) occur in 20% to 40% of patients with METex14 skipping NSCLC.1--4 As part of the multidisciplinary teams that manage cancer patients, oncology nurse navigators play a key role in optimal patient management strategy. In the phase 2 VISION study, tepotinib, a once-daily and highly selective MET tyrosine kinase inhibitor, demonstrated an objective response rate (ORR) of 50.8% and a median duration of response (mDOR) of 18.0 months in patients with METex14 skipping NSCLC (NCT02864992; Cohorts A+C, N = 313).5 Objective: To provide analysis of the intracranial activity of tepotinib in patients with METex14 skipping NSCLC with BM from the VISION study to aid oncology nurse navigators who manage this population of patients. Methods: Patients with METex14 skipping NSCLC received oral tepotinib 500 mg once daily (450 mg active moiety). Patients with BM (asymptomatic and symptomatic/stable) were eligible. The primary end point was systemic ORR by an independent review committee (RECIST v1.1, accounting for both intra- and extracranial lesions); a subgroup analysis in patients with BM was predefined (data cutoff: February 20, 2022). An exploratory analysis of brain lesions was conducted by an independent review using RANO-BM criteria. Responses were determined in patients with ≥1 evaluable postbaseline tumor assessment. For those with only nontarget lesions (NTLs) per RANO-BM (enhancing and nonenhancing NTLs), disease control was defined as at least noncomplete response/nonprogressive disease. Results: Fifty-seven patients had baseline BM (Cohorts A+C, n = 313). Systemic ORR was 56.1% (95% CI, 42.4- 69.3), and mDOR was 9.0 months (95% CI, 5.6-not estimable [ne]). Forty-three patients were evaluable by RANO-BM, 30 (69.8%) of whom received prior brain radiotherapy or surgery. Twenty-three patients were treatment-naive, and 20 patients had received prior therapy lines. Overall intracranial disease control rate was 88.4% (95% CI, 74.9-96.1) with an intracranial progression-free survival of 20.9 months (95% CI, 5.7-ne). Fifteen patients had target BM lesions. Intracranial best objective responses were complete responses in 3 patients and partial responses in 7 patients; 3 patients had stable disease and 2 had progressive disease. Overall, intracranial ORR in patients with target lesions was 66.7% (95% CI, 38.4-88.2) with an intracranial DOR of ne (95% CI, 0.9-ne). Conclusions: In summary, the MET tyrosine kinase inhibitor tepotinib showed robust systemic activity in patients with METex14 skipping NSCLC with BM. In addition, tepotinib demonstrated promising intracranial activity in an exploratory analysis conducted using RANO-BM criteria. These results will not only inform practitioners in clinical decision-making but also oncology nurse navigators responsible for optimizing the treatment experience of patients with METex14 skipping NSCLC with BM. Industry sponsor: The healthcare business of Merck KGaA, Darmstadt, Germany.
- Subjects
LUNG cancer prevention; SKULL; LUNG cancer; BRAIN; ONCOLOGY nursing; GENETIC mutation; METASTASIS; PATIENT-centered care; PROTEIN-tyrosine kinase inhibitors; TREATMENT effectiveness; GENES
- Publication
Journal of Oncology Navigation & Survivorship, 2022, Vol 13, Issue 11, p376
- ISSN
2166-0999
- Publication type
Article