Merck KGaA beats out Novartis with targeted lung cancer nod for Tepmetko in Japan

Merck kgaa
Regulators based their decision on phase 2 data from Merck KGaA's Vision study. (Merck KGaA)

Last month, Novartis got a leg up in its race against Merck KGaA to bring rival targeted lung cancer drugs to market in the U.S. But in Japan, it’s the German drugmaker that landed a victory—and nabbed its first approval on the globe.

The Japanese Ministry of Health, Labour and Welfare handed that first approval to Merck’s Tepmetko, a MET inhibitor cleared for the treatment of advanced non-small cell lung cancer patients with MET exon 14 skipping mutations, whether or not they’ve received prior therapy.

The mutations occur in 3% to 5% of NSCLC cases and are generally associated with aggressive tumors and poor prognosis, the company said.

RELATED: Novartis bags FDA priority review in tight lung cancer race against Merck KGaA

The ministry based its decision on data from the phase 2 Vision study, which showed Tepmetko could provoke a response in 42.4% of patients. Those who responded saw their benefits last for a median 12.4 months.

“With Tepmetko we are pleased to offer the first approved MET inhibitor in Japan, and a new option that can change the course of treatment for non-small cell lung cancer harboring METex14 skipping alterations,” Belén Garijo, Merck’s healthcare CEO, said in a statement.

The key word there is "first," as the Darmstadt-based company beat Novartis’ nemesis drug, capmatinib, to the punch. The Swiss pharma giant is looking for an approval in the same limited patient population, and toward that goal, it last month bagged an FDA priority review, shortening its regulatory timeline and seemingly putting it ahead of Tepmetko.

RELATED: Pfizer, Merck KGaA's Bavencio skewered by Javelin in head and neck cancer

Merck will take the wins it can get in the oncology department, where its Pfizer-partnered PD-L1 drug, Bavencio, has repeatedly stumbled. Most recently, the immuno-oncology drug failed to show a significant benefit in a phase 3 study in head and neck cancer study, prompting the companies to scrap yet another trial.

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