Publications
Detailed Information
Randomized Trial of Tepotinib Plus Gefitinib versus Chemotherapy in EGFR-Mutant NSCLC with EGFR Inhibitor Resistance Due to MET Amplification: INSIGHT Final Analysis
DC Field | Value | Language |
---|---|---|
dc.contributor.author | Liam, Chong Kin | - |
dc.contributor.author | Ahmad, Azura Rozila | - |
dc.contributor.author | Hsia, Te-Chun | - |
dc.contributor.author | Zhou, Jianying | - |
dc.contributor.author | Kim, Dong-Wan | - |
dc.contributor.author | Soo, Ross Andrew | - |
dc.contributor.author | Cheng, Ying | - |
dc.contributor.author | Lu, Shun | - |
dc.contributor.author | Shin, Sang Won | - |
dc.contributor.author | Yang, James Chih-Hsin | - |
dc.contributor.author | Zhang, Yiping | - |
dc.contributor.author | Zhao, Jun | - |
dc.contributor.author | Berghoff, Karin | - |
dc.contributor.author | Bruns, Rolf | - |
dc.contributor.author | Johne, Andreas | - |
dc.contributor.author | Wu, Yi-Long | - |
dc.date.accessioned | 2023-06-09T00:18:30Z | - |
dc.date.available | 2023-06-09T00:18:30Z | - |
dc.date.created | 2023-06-07 | - |
dc.date.created | 2023-06-07 | - |
dc.date.created | 2023-06-07 | - |
dc.date.created | 2023-06-07 | - |
dc.date.issued | 2023-05 | - |
dc.identifier.citation | Clinical Cancer Research, Vol.29 No.10, pp.1879-1886 | - |
dc.identifier.issn | 1078-0432 | - |
dc.identifier.uri | https://hdl.handle.net/10371/192800 | - |
dc.description.abstract | Purpose: The final analyses of the INSIGHT phase II study evaluating tepotinib (a selective MET inhibitor) plus gefitinib versus chemotherapy in patients with MET-altered EGFR-mutant NSCLC (data cut-off: September 3, 2021). Patients and Methods: Adults with advanced/metastatic EGFR- mutant NSCLC, acquired resistance to first-/second-generation EGFR inhibitors, and MET gene copy number (GCN) >= 5, MET: CEP7 >= 2, or MET IHC 2+/3+ were randomized to tepotinib 500 mg (450 mg active moiety) plus gefitinib 250 mg once daily, or chemo-therapy. Primary endpoint was investigator-assessed progression-free survival (PFS). MET-amplified subgroup analysis was preplanned. Results: Overall (N = 55), median PFS was 4.9 months versus 4.4 months [stratified HR, 0.67; 90% CI, 0.35-1.28] with tepotinib plus gefitinib versus chemotherapy. In 19 patients with MET amplification (median age 60.4 years; 68.4% never-smokers; median GCN 8.8; median MET/CEP7 2.8; 89.5% with MET IHC 3+), tepotinib plus gefitinib improved PFS (HR, 0.13; 90% CI, 0.04- 0.43) and overall survival (OS; HR, 0.10; 90% CI, 0.02-0.36) versus chemotherapy. Objective response rate was 66.7% with tepotinib plus gefitinib versus 42.9% with chemotherapy; median duration of response was 19.9 months versus 2.8 months. Median duration of tepotinib plus gefitinib was 11.3 months (range, 1.1-56.5), with treatment >1 year in six (50.0%) and >4 years in three patients (25.0%). Seven patients (58.3%) had treatment-related grade >= 3 adverse events with tepotinib plus gefitinib and five (71.4%) had chemotherapy. Conclusions: Final analysis of INSIGHT suggests improved PFS and OS with tepotinib plus gefitinib versus chemotherapy in a subgroup of patients with MET-amplified EGFR-mutant NSCLC, after progression on EGFR inhibitors. | - |
dc.language | 영어 | - |
dc.publisher | American Association for Cancer Research | - |
dc.title | Randomized Trial of Tepotinib Plus Gefitinib versus Chemotherapy in EGFR-Mutant NSCLC with EGFR Inhibitor Resistance Due to MET Amplification: INSIGHT Final Analysis | - |
dc.type | Article | - |
dc.identifier.doi | 10.1158/1078-0432.CCR-22-3318 | - |
dc.citation.journaltitle | Clinical Cancer Research | - |
dc.identifier.wosid | 000988227700001 | - |
dc.identifier.scopusid | 2-s2.0-85159735583 | - |
dc.citation.endpage | 1886 | - |
dc.citation.number | 10 | - |
dc.citation.startpage | 1879 | - |
dc.citation.volume | 29 | - |
dc.description.isOpenAccess | Y | - |
dc.contributor.affiliatedAuthor | Kim, Dong-Wan | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordPlus | CELL LUNG-CANCER | - |
dc.subject.keywordPlus | OSIMERTINIB | - |
dc.subject.keywordPlus | MULTICENTER | - |
dc.subject.keywordPlus | SAVOLITINIB | - |
dc.subject.keywordPlus | MECHANISMS | - |
dc.subject.keywordPlus | TKI | - |
- Appears in Collections:
- Files in This Item:
- There are no files associated with this item.
Item View & Download Count
Items in S-Space are protected by copyright, with all rights reserved, unless otherwise indicated.