TRLS-03. Intracranial activity of tepotinib in patients with MET exon 14 (METex14) skipping NSCLC enrolled in VISION
| Autor: | Ingel K. Demedts, Julien Mazieres, Aurora O'Brate, Ian Churchill Anderson, Jyoti D. Patel, Masahiro Morise, S. Peter Eggleton, M.C. Garassino, Egbert F. Smit, G. Otto, Remi Veillon, Paul K. Paik, Rolf Bruns, Christine M. Bestvina, Karl Maria Schumacher, Xiuning Le |
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| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
medicine.diagnostic_test Neurologic Oncology business.industry medicine.medical_treatment Magnetic resonance imaging Supplement Abstracts Progressive Neoplastic Disease Radiation therapy Exon Basic Science Response Evaluation Criteria in Solid Tumors AcademicSubjects/MED00300 Medicine Brain lesions AcademicSubjects/MED00310 In patient Radiology business |
| Zdroj: | Neuro-oncology Advances |
| ISSN: | 2632-2498 |
| DOI: | 10.1093/noajnl/vdab071.021 |
| Popis: | Background Brain metastases (BMs) are reported in 20–40% patients with METex14 skipping NSCLC. Tepotinib, a highly selective MET inhibitor, has demonstrated an objective response rate (ORR) of 45% and median duration of response (mDOR) of 11.1 months, in METex14 skipping NSCLC patients in Cohort A of the Phase II VISION study. Here, we report the intracranial activity of tepotinib in Cohort A. Methods Patients received oral tepotinib 500 mg QD. Study eligibility allowed for patients with BM (asymptomatic and symptomatic/stable). Primary endpoint: systemic objective response (RECIST v1.1); subgroup analysis in patients with BM (RECIST v1.1) was predefined. An ad hoc retrospective analysis of brain lesions (by CT/MRI) was conducted by an IRC using Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria. Responses were determined in patients with ≥1 evaluable post-baseline tumor assessment. For non-measurable lesions (enhancing and non-enhancing non-target lesions [NTL]), disease control in the brain was defined as non-complete response/non-progressive disease. Data cut-off: July 1, 2020. Results Twenty-three patients had baseline BM. Systemic efficacy in patients with BM (ORR 47.8% [95% CI: 26.8, 69.4]; mDOR 9.5 months [95% CI: 5.5, not estimable]) was consistent with the overall population. Fifteen patients were evaluable by RANO-BM; 12 received prior radiotherapy for BM (median 6.4 weeks before treatment). Systemic best objective responses (BORs) were partial response (PR, n=9), stable disease (SD, n=3), and progressive disease (PD; n=3). Of seven patients with measurable CNS disease (all of whom received prior radiotherapy), intracranial BORs were PR (n=5), SD (n=1), and PD (n=1). For patients with NTL only (n=8), one had PD, and seven achieved intracranial disease control with three patients achieving CR of the enhancing NTL. Conclusions Tepotinib demonstrated intracranial activity in patients with METex14 skipping NSCLC with BM. Prospective evaluation of intracranial activity in VISION Cohort C is ongoing. |
| Databáze: | OpenAIRE |
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