{"id":328301,"date":"2021-08-11T08:55:40","date_gmt":"2021-08-11T06:55:40","guid":{"rendered":"https:\/\/medizinonline.com\/new-therapeutic-option-for-metastatic-nsclc-with-metex14-skipping-mutation\/"},"modified":"2021-08-11T08:55:40","modified_gmt":"2021-08-11T06:55:40","slug":"new-therapeutic-option-for-metastatic-nsclc-with-metex14-skipping-mutation","status":"publish","type":"post","link":"https:\/\/medizinonline.com\/en\/new-therapeutic-option-for-metastatic-nsclc-with-metex14-skipping-mutation\/","title":{"rendered":"New therapeutic option for metastatic NSCLC with METex14 skipping mutation."},"content":{"rendered":"

The growing understanding of tumor genetic mechanisms and the development of molecular diagnostics have enabled the development of targeted therapies, leading to significant advances in the treatment of lung cancer [1]. The approval of selective MET inhibitors<\/em> has expanded treatment options for patients with metastatic non-small cell lung cancer (NSCLC) and a MET tyrosine kinase receptor exon 14<\/em>(METex14<\/em>) skipping mutation [2, 3].<\/p>\n

<\/p>\n

Approximately 80-90% of lung cancer cases are non-small cell lung cancer (NSCLC) [4]. Approximately 3-4% of these patients have a MET exon 14<\/em>(METex14<\/em>) skipping driver mutation [5]. This mostly affects patients over 70 years of age and is associated with a poor prognosis, partly because previous therapeutic approaches have had little effect [5-7].<\/p>\n

TEPMETKO\u00ae: Selective oral, once-daily MET inhibitor<\/em>[2].<\/strong><\/p>\n

TEPMETKO\u00ae is the only MET inhibitor<\/em> approved in Switzerland that selectively inhibits the oncogenic signaling chain triggered by the MET mutation<\/em> and is administered orally once daily [2, 3]*. Patients eligible for therapy with TEPMETKO\u00ae can be identified by screening based on next-generation sequencing. These are already performed as standard for mutations of comparable frequency, such as ALK [1, 4, 5]. NCCN guidelines already recommend TEPMETKO\u00ae as first-line therapy for metastatic NSCLC with a METex14 skipping mutation<\/em>[8].<\/p>\n

Rapid, consistent and sustained response [2].<\/strong><\/p>\n

The approval is based on the positive results of an interim analysis of the open-label phase II VISION trial [5]. This analysis evaluated pooled safety data from 448 patients (including 255 from the main VISION clinical trial) and efficacy data from 152 patients who received oral 450 mg of TEPMETKO\u00ae once daily. 45% of patients were treated with TEPMETKO\u00ae in the first line and 55% in the second or follow-up line. 10% of patients had stable brain metastases at baseline [2].<\/p>\n

The primary endpoint was overall response rate (ORR) assessed by an independent review committee (IRC). Here, TEPMETKO\u00ae resulted in an ORR of 44.7%, independent of line of therapy(Table<\/strong>), patient age, type of prior therapies, and presence of brain metastases. Patients not only responded rapidly, typically within 6 weeks, but also showed a sustained response to TEPMETKO\u00ae with a median response duration of 11.1 months [2, 5]. Overall, TEPMETKO\u00ae was well tolerated, with grade \u22653 adverse effects occurring in 25.1% of patients and 10.6% discontinuing treatment prematurely [9].<\/p>\n

\"\"
\nTable:<\/strong> Results of the VISION study according to the Independent Review Committee (IRC) [2]. Overall response rate (ORR), median duration of response (mDOR), median progression-free survival (mPFS), and median overall survival (mOS) after treatment with TEPMETKO\u00ae.<\/p>\n

Conclusion<\/strong><\/p>\n

TEPMETKO\u00ae is the only once-daily selective therapy for metastatic NSCLC with METex14 skipping mutation*<\/em>approved in Switzerland [2]. The oral MET inhibitor<\/em> is already recommended by  the NCCN guidelines as first-line therapy for this patient population [8]. The new selective therapy is a major advance for personalized medicine and underscores the importance of routine biomarker testing [1, 5].<\/p>\n

_________________________________________<\/p>\n

*The efficacy and safety of Tepmetko has not been studied in patients with additional oncogenic driver mutations including EGFR or ALK tumor aberrations [2].
\nMETex14<\/em>= mesenchymal-epithelial transition exon 14<\/p>\n

 <\/p>\n

With the financial support of Merck (Schweiz) AG.<\/p>\n

CH-TEP-00051 05\/2022<\/p>\n

Brief technical information TEPMETKO\u00ae<\/a><\/p>\n

 <\/p>\n

Literature<\/strong><\/p>\n

1. Rosell, R. and N. Karachaliou, Large-scale screening for somatic mutations in lung cancer. The Lancet, 2016. 387(10026): p. 1354-1356.<\/span><\/div>\n
2. current technical information TEPMETKO\u00ae. www.swissmedicinfo.ch<\/a>. Status: June 2021<\/span><\/div>\n
3. List of approved human drugs. www.swissmedic.ch\/swissmedic\/de\/home\/services\/listen_neu.html<\/a>. Status: June 2021.<\/span><\/div>\n
4. Planchard, D., et al, Metastatic non-small cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Annals of Oncology, 2018. 29: p. iv192-iv237.<\/span><\/div>\n
Paik, P.K., et al, Tepotinib in non-small-cell lung cancer with MET exon 14 skipping mutations. New England Journal of Medicine, 2020. 383(10): p. 931-943.<\/span><\/div>\n
6 Awad, M.M., et al, Impact of MET inhibitors on survival among patients with non-small cell lung cancer harboring MET exon 14 mutations: a retrospective analysis. Lung Cancer, 2019. 133: p. 96-102.<\/span><\/div>\n
7. Tong, J.H., et al, MET Amplification and Exon 14 Splice Site Mutation Define Unique Molecular Subgroups of Non-Small Cell Lung Carcinoma with Poor Prognosis. Clin Cancer Res, 2016. 22(12): p. 3048-56.<\/span><\/div>\n
8th National Comprehensive Cancer Network. Non-Small Cell Lung Cancer (version 4.2021). http:\/\/www.nccn.org\/professionals\/physician_gls\/pdf\/nscl.pdf<\/a>. Status: June 2021.<\/span><\/div>\n
9. Veillon, R., Tepotinib Safety in MET Exon 14 (METex14) Skipping NSCLC: Updated Results from the VISION Trial. FP14.09 IASCL 01\/21. https:\/\/library.iaslc.org\/<\/a>. Status: June 2021.<\/span><\/div>\n
 <\/div>\n
 <\/div>\n
References are available upon request.<\/div>\n

Article online since 11.08.2021<\/p>\n

 <\/div>\n
 <\/div>\n
 <\/div>\n","protected":false},"excerpt":{"rendered":"

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