FDA Approval Summary: Capmatinib and Tepotinib for the Treatment of Metastatic NSCLC Harboring MET Exon 14 Skipping Mutations or Alterations

被引：100

作者：

Mathieu, Luckson N. ^{[1
]}

Larkins, Erin ^{[1
]}

Akinboro, Oladimeji ^{[1
]}

Roy, Pourab ^{[1
]}

Amatya, Anup K. ^{[1
]}

Fiero, Mallorie H. ^{[1
]}

Mishra-Kalyani, Pallavi S. ^{[1
]}

Helms, Whitney S. ^{[1
]}

Myers, Claire E. ^{[1
]}

Skinner, Amy M. ^{[1
]}

Aungst, Stephanie ^{[1
]}

Jin, Runyan ^{[1
]}

Zhao, Hong ^{[1
]}

Xia, Huiming ^{[1
]}

Zirkelbach, Jeanne Fourie ^{[1
]}

Bi, Youwei ^{[1
]}

Li, Yangbing ^{[1
]}

Liu, Jiang ^{[1
]}

Grimstein, Manuela ^{[1
]}

Zhang, Xinyuan ^{[1
]}

Woods, Stacie ^{[1
]}

Reece, Kelie ^{[1
]}

Abukhdeir, Abdelrahmman M. ^{[2
]}

Ghosh, Soma ^{[2
]}

Philip, Reena ^{[2
]}

Tang, Shenghui ^{[1
]}

Goldberg, Kirsten B. ^{[3
]}

Pazdur, Richard ^{[1
,3
]}

Beaver, Julia A. ^{[1
,3
]}

Singh, Harpreet ^{[1
,3
]}

机构：

[1] US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA

[2] US FDA, Ctr Device & Radiol Hlth, Silver Spring, MD 20993 USA

[3] US FDA, Oncol Ctr Excellence, Silver Spring, MD 20993 USA

来源：

CLINICAL CANCER RESEARCH | 2022年 / 28卷 / 02期

关键词：

LUNG-CANCER;

D O I：

10.1158/1078-0432.CCR-21-1566

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

The FDA approved capmatinib and tepotinib on May 6, 2020, and February 3, 2021, respectively. Capmatinib is indicated for patients with metastatic non-small cell lung cancer (mNSCLC) whose tumors have a mutation leading to mesenchymal- epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test. Tepotinib is indicated for mNSCLC harboring MET exon 14 skipping alterations. The approvals were based on trials GEOMETRY mono-1 (capmatinib) and VISION (tepotinib). In GEOMETRY mono-1, overall response rate (ORR) per Blinded Independent Review Committee (BIRC) was 68% [95% confidence interval (CI), 48-84] with median duration of response (DoR) 12.6 months (95% CI, 5.5-25.3) in 28 treatment-naive patients and 41% (95% CI: 29, 53) with median DoR 9.7 months (95% CI, 5.5-13) in 69 previously treated patients with NSCLC with mutations leading to MET exon 14 skipping. In VISION, ORR per BIRC was 43% (95% CI: 32, 56) with median DoR 10.8 months (95% CI, 6.9-not estimable) in 69 treatment naive patients and 43% (95% CI, 33-55) with median DoR 11.1 months (95% CI, 9.5-18.5) in 83 previously-treated patients with NSCLC harboring MET exon 14 alterations. These are the first two therapies to be FDA approved specifically for patients with metastatic NSCLC with MET exon 14 skipping.

引用

页码：249 / 254

页数：6

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