In two-way race with Novartis, Merck scores first regulatory approval for targeted lung cancer drug
In the two-man race to develop a new inhibitor for an aggressive form of lung cancer, Merck KGaA has won the first regulatory approval.
Japan became the first country to approve the pharma giant’s MET inhibitor tepotinib, the first targeted pill for the 3 to 4% of non-small lung cancer patients with a MET mutation. In a Phase II study published last year in Clinical Oncology, just over half of the 89 patients responded to the treatment. The response lasted for a median of 9.8 months.
Merck presented that data at ASCO a year ago — the same day Novartis presented data on their MET inhibitor capmatinib, which showed a 68% overall response in first-line patients and 41% in second-line patients. At the time, Merck’s data showed 59% in first-line patients and 45% in second-line patients. Duration of response was similar, although Merck’s drug looked to be more tolerable.
The Japanese decision clears tepotinib as both a first and later-line therapy and means it will be the first of the two drugs to reach patients. Novartis, though, has the lead on US approval. Last month, the Swiss drugmaker filed for FDA approval and won priority review. They didn’t announce a PDUFA date, but barring any pandemic-related disruptions or other delays, the award should cut four months off the usual process and bring a decision in August.
Merck shouldn’t be far behind. They, like Novartis, won breakthrough status for the drug — often a precursor to priority review — and are thought to be nearing an FDA submission.
The specific mutation both drugs target is known as a MET exon 14 skipping mutation. That exon codes for an E3 ligase binding site, the area the body’s protein degradation system latches onto to dispose of the protein. Its absence has several downstream effects, including an accumulation of MET, that help give rise to cancer.
Novartis CEO Vas Narasimhan included the company’s MET inhibitor as one of seven potential blockbusters the company was hoping to bring on to the market in 2020. It was originally developed by Incyte.