FDA Grants Accelerated Approval to Merck's MET Inhibitor Tepmetko (tepotinib) for First-Line Treatment of Metastatic NSCLC with METex14 Skipping Alterations

Today, EMD Serono, a business of Merck KGaA, announced that the U.S. FDA has granted accelerated approval for the oral MET inhibitor Tepmetko (tepotinib) for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring MET exon 14 (METex14) skipping mutations.

Lung cancer is one of the most common types of cancer globally and a leading cause of cancer-related deaths, with 1.9 million deaths worldwide each year. Alterations in the MET signaling pathway, including MET exon 14 skipping alterations, are estimated to occur in 3%–4% of NSCLC cases.

Tepmetko is an oral MET inhibitor designed to suppress oncogenic MET receptor signaling caused by MET gene alterations. It was previously granted Breakthrough Therapy Designation by the U.S. FDA. In March this year, it was approved by Japan’s Ministry of Health, Labour and Welfare (MHLW) for the treatment of patients with unresectable, advanced, or recurrent non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping mutations. This marks the first regulatory approval of a MET inhibitor worldwide.

This approval was supported by the pivotal Phase 2 VISION clinical trial. A total of 152 patients with advanced or metastatic non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping alterations received monotherapy with Tepmetko. These patients did not carry EGFR or ALK gene mutations.

The trial results showed that Tepmetko achieved an overall response rate of 43% in both treatment-naïve and previously treated patients. The median duration of response (DOR) was 10.8 months (95% CI, 6.9–NE) for treatment-naïve patients and 11.1 months (95% CI, 9.5–18.5) for previously treated patients. The duration of response exceeded 6 months in 67% of treatment-naïve patients and 75% of previously treated patients, and exceeded 9 months in 30% of treatment-naïve patients and 50% of previously treated patients.

“Patients with MET exon 14 skipping-mutated NSCLC are often older and face a poor clinical prognosis,” said Dr. Paul K. Paik, Principal Investigator of the VISION trial and Clinical Director of Thoracic Oncology at Memorial Sloan Kettering Cancer Center. “There is an urgent need for targeted therapies that can deliver durable anticancer activity. Tepmetko provides an important new treatment option for patients with metastatic NSCLC harboring these genetic alterations.”

MET has become one of the hottest research targets in the field of oncology. Last May, the FDA granted accelerated approval for Novartis' MET inhibitor Tabrecta (capmatinib). In China, although no drugs targeting MET abnormality-related indications have been approved yet, more than a dozen companies, including Hutchison China MediTech and Hansoh Pharmaceutical, are developing innovative MET-targeted therapies, with many R&D projects already entering clinical stages.

Note: This article is intended to introduce research in medicine and health, not to recommend treatment plans. For guidance on treatment plans, please visit a reputable hospital.

References:

[1] FDA Approves TEPMETKO® as the First and Only Once-daily Oral MET Inhibitor for Patients with Metastatic NSCLC with METex14 Skipping Alterations. Retrieved February 3, 2021, from https://www.prnewswire.com/news-releases/fda-approves-tepmetko-as-the-first-and-only-once-daily-oral-met-inhibitor-for-patients-with-metastatic-nsclc-with-metex14-skipping-alterations-301221542.html

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