Tepotinib Gets Priority Review for Metastatic NSCLC With METex14 Skipping Mutation

The Food and Drug Administration (FDA) has granted Priority Review to tepotinib (EMD Serono) for the treatment of adults with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition exon 14 (METex14) skipping, as detected by an FDA-approved test.

The application is supported by data from the ongoing, open-label, single-arm phase 2 VISION study evaluating the MET inhibitor as monotherapy in patients with advanced NSCLC with METex14 skipping alterations prospectively assessed by liquid and/or tissue biopsy. The primary end point of the study was objective response as assessed by an independent review committee among patients who had undergone at least 9 months of follow up.

Results showed that in the combined biopsy group, the response rate was 46% (95% CI, 36-57) with a median duration of response of 11.1 months. Among the 66 patients in the liquid biopsy group and the 60 patients in the tissue biopsy group, the response rates were reported to be 48% (95% CI, 36-61) and 50% (95% CI, 37-63), respectively. Additionally, the investigator-assessed response rate was 56% (95% CI, 45-66).

As for safety, adverse events of grade ≥3 occurred in 28% of patients; peripheral edema was reported in 7% of patients. Treatment with tepotinib was permanently discontinued in 11% of patients due to adverse events. 

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METex14 skipping alterations drive a particularly aggressive form of NSCLC in a patient population that is generally elderly, facing poor clinical prognosis and in urgent need of new therapeutic options,” said Luciano Rossetti, Global Head of Research & Development for EMD Serono. “With this acceptance and review under the [Real-Time Oncology Review] program, we look forward to working with FDA and to making this precision medicine available to patients in the US as soon as possible.” 

The Company is also investigating tepotinib in the phase 2 INSIGHT 2 study in combination with osimertinib in MET amplified, advanced or metastatic NSCLC harboring activating EGFR mutations that has progressed following first-line treatment with osimertinib. 

For more information visit emdserono.com.


  1. FDA accepts filing of New Drug Application for tepotinib for the treatment of patients with metastatic NSCLC with METex14 skipping alterations. https://www.prnewswire.com/news-releases/fda-accepts-filing-of-new-drug-application-for-tepotinib-for-the-treatment-of-patients-with-metastatic-nsclc-with-metex14-skipping-alterations-301117906.html. Accessed August 25, 2020. 
  2. Paik PK, Felip E, Veillon R, et al. Tepotinib in non-small cell lung cancer with MET exon 14 skipping mutations [published online May 29, 2020]. The New England Journal of Medicine. doi: 10.1056/NEJMoa2004407.