Back to Search
Start Over
Capmatinib in Japanese patients with MET exon 14 skipping–mutated or MET ‐amplified advanced NSCLC: GEOMETRY mono‐1 study
- Source :
- Cancer Science
- Publication Year :
- 2021
- Publisher :
- Wiley, 2021.
-
Abstract
- MET mutations leading to exon 14 skipping (METΔex14) are strong molecular drivers for non–small‐cell lung cancer (NSCLC). Capmatinib is a highly potent, selective oral MET inhibitor that showed clinically meaningful efficacy and a manageable safety profile in a global phase II study (GEOMETRY mono‐1, NCT02414139) in patients with advanced METΔex14‐mutated/MET‐amplified NSCLC. We report results of preplanned analyses of 45 Japanese patients according to MET status (METΔex14‐mutated or MET‐amplified) and line of therapy (first‐ [1L] or second‐/third‐line [2/3L]). The starting dose was 400 mg twice daily. The primary endpoint was the objective response rate (ORR) assessed by a blinded independent review committee. A key secondary endpoint was duration of response (DOR). Among METΔex14‐mutated patients, in the 1L group, one patient achieved partial response (DOR of 4.24 months) and the other had stable disease. In the 2/3L group, the ORR was 36.4% (95% confidence interval [CI] 10.9%‐69.2%), median DOR was not evaluable, and progression‐free survival was 4.70 months. One patient (2/3L group) showed partial resolution of brain lesions per independent neuroradiologist review. In MET‐amplified patients with a MET gene copy number of ≥10, the ORR was 100% (2/2 patients) in the 1L group and 45.5% (5/11 patients) in the 2/3L group, with DOR of 8.2 and 8.3 months, respectively. Common treatment‐related adverse events among the 45 Japanese patients were blood creatinine increased (53.3%), nausea (35.6%), and oedema peripheral (31.1%); most were grade 1/2 severity. In conclusion, capmatinib was effective and well tolerated by Japanese patients with METΔex14/MET‐amplified NSCLC, consistent with the overall population.<br />We describe results for Japanese patients enrolled in a global phase II study (GEOMETRY mono‐1, NCT02414139), which investigated the efficacy and safety of capmatinib in patients with advanced non–small‐cell lung cancer (NSCLC) harboring MET exon 14 skipping mutations (METΔex14). Capmatinib was effective and well tolerated by Japanese patients. The results are consistent with those observed in the overall population enrolled in GEOMETRY mono‐1.
- Subjects :
- safety
Male
0301 basic medicine
Cancer Research
medicine.medical_specialty
Lung Neoplasms
non–small‐cell lung cancer
Nausea
Population
Phases of clinical research
Gastroenterology
03 medical and health sciences
0302 clinical medicine
Stable Disease
Japan
Clinical Research
Carcinoma, Non-Small-Cell Lung
Internal medicine
MET receptor tyrosine kinase
Clinical endpoint
medicine
Humans
education
Lung cancer
Adverse effect
Protein Kinase Inhibitors
Aged
capmatinib
Aged, 80 and over
education.field_of_study
response
Triazines
business.industry
Imidazoles
Exons
General Medicine
Proto-Oncogene Proteins c-met
medicine.disease
Confidence interval
030104 developmental biology
Oncology
030220 oncology & carcinogenesis
Benzamides
Mutation
Original Article
Female
ORIGINAL ARTICLES
medicine.symptom
business
Subjects
Details
- ISSN :
- 13497006, 13479032, and 02414139
- Volume :
- 112
- Database :
- OpenAIRE
- Journal :
- Cancer Science
- Accession number :
- edsair.doi.dedup.....a5c7374ae2bf06cec3c32db9e22a23fc