Merck KGaA's Tepotinib Gets Fast Track Designation In Japan

Merck KGaA MKGAF announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted SAKIGAKE 'fast-track' designation to its pipeline candidate, tepotinib. The company is developing the candidate for the treatment of advanced non-small cell lung cancer (“NSCLC”).

The SAKIGAKE designation is granted to expedite a candidate’s development and review in Japan and focuses on new or unmet areas and regenerative medicines.

Merck KGaA’s shares have underperformed the industry so far this year. The stock has lost 14.8% compared with the industry’s decline of 4.6% in that period.

The designation was granted to tepotinib based on data from a phase II study evaluating it in NSCLC patients with MET exon 14 skipping mutations. There is no approved treatment for this indication.

Data from the study will be presented at a future medical congress.

Apart from tepotinib, Merck KGaA‘s oncology pipeline includes M7824, which is a bifunctional immunotherapy as it simultaneously blocks 2 immuno-inhibitory pathways that are commonly used by cancer cells. The company is evaluating the candidate in several tumors. However, the most advanced candidate in oncology pipeline, avelumab, is being developed in collaboration with Pfizer (NYSE:PFE) in several indications, including lung, gastric, ovarian and kidney cancer.

Per the press release, lung cancer is the most common cancer globally. NSCLC occurs in 80% to 85% of lung cancer patients. However, tepotinib targets only 2% to 3% of NSCLC patients, who have MET exon 14 skipping mutations.

However, several big pharma companies are already marketing their drugs to treat NSCLC. These include Merck’s (NYSE:MRK) anti-PD-1 therapy, Keytruda; Pfizer’s Xalkori and Bristol-Myers’ (NYSE:BMY) PD-1 immune checkpoint inhibitor, Opdivo.

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