Merck Announces Phase 2 Positive Data for Tepotinib Hepatocellular Carcinoma

2023-12-13 22:07:48

June 14, 2018 Source: Sina Pharmaceutical

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Recently, Merck Pharmaceuticals of Germany announced positive data on two phase 2 clinical studies of the company's targeted drug tepotinib for the treatment of MET-positive liver function grade Child-Pugh Class A advanced hepatocellular carcinoma. Both studies have reached the most important end. The trial evaluated the efficacy, safety, and pharmacokinetics of tepotinib as a first-line treatment (NCT01988493) and second-line therapy (NCT02115373) in patients with hepatocellular carcinoma. Tepotinib is an important research-based treatment for Merck, and is at a critical position in the company's strategic focus on innovative precision drug development.

Luciano Rossetti, Head of Global R&D at Merck Biopharma, said: "These results, together with the mid-term data on the treatment of advanced non-small cell lung cancer patients with MET exon 14 skip mutations demonstrated at ASCO, further demonstrate tepotinib as an innovation. The potential of precision medicine. Although this is a positive result, considering the continuous development of treatment standards for hepatocellular carcinoma, we will assess whether it is possible to use tepotinib as a combination therapy rather than a monotherapy in this indication."

Both hepatocellular carcinoma trials recruited patients with advanced, MET-positive tumors and Child-Pugh Class A liver function. The NCT01988493 study was a randomized, multicenter Phase Ib/II trial evaluating tepotinib as a first-line therapy compared with sorafenib for Asian patients (phase 2: tepotinib 45, sorafenib 45, randomly divided into two Group) treatment differences. The primary endpoint of the phase 2 trial was the time to progression as assessed by the Independent Review Committee (RECIST version 1.1). The NCT02115373 study was a multicenter, one-arm Ib/II trial to study tepotinib as a second-line therapy for patients who were not treated with sorafenib (Phase 2 trial: 49 cases of tepotinib). The primary endpoint of the NCT 02115373 Phase 2 trial was progression-free survival at 12 weeks (assessed according to RECIST version 1.1).

In both trials, the safety data for tepotinib was consistent with the data observed during the Ib phase of liver cancer research, and no new safety signals were found. Hepatocellular carcinoma data will be published in more detail at a scientific conference later this year.

Tepotinib was discovered by Merck and belongs to the c-Met receptor tyrosine kinase inhibitor. The c-Met signaling pathway has been found to be altered in a variety of cancer types and is associated with aggressive tumor behavior and poor clinical outcomes. Tepotinib is designed to improve the prognosis of invasive tumors with poor prognosis and retaining these specific mutations.

As part of an ongoing clinical program, Merck is conducting a phase 2 study of tepotinib for the treatment of advanced non-small cell lung cancer (NSCLC) containing MET exon 14 skip mutation. The MET 14 exon skip is a target gene change. The interim data for this study was recently published at the ASCO Annual Meeting, showing the antitumor activity of the drug in this patient group and the safety consistent with that observed in previous studies.

In March of this year, the Ministry of Health, Labor and Welfare of Japan issued a SAKIGAKE (fast track) qualification for tepotinib for the treatment of MET 14 exon skipping mutation NSCLC. (The Ministry of Health, Labor and Welfare grants the title SAKIGAKE, a drug designed to promote the advancement of drugs in Japan and the early practical application of innovative drugs, medical devices and regenerative drugs. The designated grant can shorten the review period of drugs from 12 months to 12 months. 6 months.) (Sina Pharmaceutical Compilation / David)

Articles, images reference source: Merck Provides Update on Tepotinib Phase II Results in Advanced Hepatocellular Carcinoma

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