Novartis’ Tabrecta and Merck KGaA’s Tepmetko recently won approval in the United States for a rare type of non-small cell lung cancer that harbors MET exon 14 skipping mutations.
But there’s another therapy for the disease, and it has become the first to be endorsed in China.
AstraZeneca and HutchMed’s Orpathys (savolitinib) has scored a conditional nod for patients with the rare cancer who have progressed following prior systemic therapy or are unable to receive chemotherapy. This is the first global approval for the oral MET tyrosine kinase inhibitor.
Orpathys should have a ready market. While the mutations occur in roughly 3% of newly diagnosed NSCLC patients, more than a third of those in the world reside in China, AstraZeneca says. The aggressive condition, which often is fatal, is more common in the elderly and is usually resistant to chemotherapy.
The approval came after a phase 2 trial in China in which Orpathys showed strong anti-tumor activity. The nod is contingent upon the successful completion of a confirmatory trial in the same patient population.
HutchMed, formerly known as Chi-Med, was the initial developer of savolitinib. The company welcomed AstraZeneca as a partner 10 years ago.
“Our collaboration with AstraZeneca in 2011 has been an important driver in the development of (Orpathys),” HutchMed CEO Christian Hogg said in a statement. “We are hopeful that this is only the beginning of the progress we can achieve for patients with MET-altered tumors.”
With Tabrecta, Novartis was the first to the FDA finish line in the disease last May. In February of this year, Merck KGaA followed suit with its approval for Tepmetko. Both of the FDA nods were for use in patients regardless of whether they had received prior treatment.
Orpathys is one of three promising oncology assets for HutchMed. The others are surufatinib, which was recently approved in China for pancreatic and non-pancreatic neuroendocrine tumors, and fruquintinib, which has been launched in China for late-stage colorectal cancer.
"The company continues to make good progress with its global registration strategy for all three assets," wrote Cantor Fitzgerald in a report to investors last month. "HutchMed is well-positioned for transformative global growth over the next few years."