Capmatinib in Japanese patients with <i>MET</i> exon 14 skipping–mutated or <i>MET</i>‐amplified advanced NSCLC: GEOMETRY mono‐1 study
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- Takashi Seto
- Department of Thoracic Oncology National Hospital Organization Kyushu Cancer Center Fukuoka Japan
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- Kadoaki Ohashi
- Department of Respiratory Medicine Okayama University Hospital Okayama Japan
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- Shunichi Sugawara
- Sendai Kousei Hospital Miyagi Japan
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- Makoto Nishio
- Thoracic Center Cancer Institute Hospital of JFCR Tokyo Japan
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- Masayuki Takeda
- Department of Medical Oncology Kindai University Faculty of Medicine Osaka Japan
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- Keisuke Aoe
- Department of Medical Oncology National Hospital Organization Yamaguchi‐Ube Medical Center Yamaguchi Japan
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- Sanae Moizumi
- Development Division Novartis Pharma K.K. Tokyo Japan
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- Satoshi Nomura
- Development Division Novartis Pharma K.K. Tokyo Japan
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- Takeshi Tajima
- Development Division Novartis Pharma K.K. Tokyo Japan
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- Toyoaki Hida
- Department of Thoracic Oncology Aichi Cancer Center Hospital Aichi Japan
抄録
<jats:title>Abstract</jats:title><jats:p><jats:italic>MET</jats:italic> mutations leading to exon 14 skipping (<jats:italic>MET</jats:italic>Δex14) 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 <jats:italic>MET</jats:italic>Δex14‐mutated/<jats:italic>MET</jats:italic>‐amplified NSCLC. We report results of preplanned analyses of 45 Japanese patients according to <jats:italic>MET</jats:italic> status (<jats:italic>MET</jats:italic>Δex14‐mutated or <jats:italic>MET</jats:italic>‐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 <jats:italic>MET</jats:italic>Δex14‐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 <jats:italic>MET</jats:italic>‐amplified patients with a <jats:italic>MET</jats:italic> 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 <jats:italic>MET</jats:italic>Δex14/<jats:italic>MET</jats:italic>‐amplified NSCLC, consistent with the overall population.</jats:p>
収録刊行物
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- Cancer Science
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Cancer Science 112 (4), 1556-1566, 2021-02-24
Wiley
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詳細情報 詳細情報について
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- CRID
- 1360576118762486656
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- ISSN
- 13497006
- 13479032
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- データソース種別
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- Crossref
- KAKEN