Zai Lab grabs rights to Turning Point's lung cancer therapy for China

Cancer-focused Zai Lab added to its R&D pipeline last week with an exclusive licensing agreement with Turning Point Therapeutics to develop that company's lead drug, repotrectinib.

The Nasdaq-listed Chinese biotech will pay $25 million upfront to develop and commercialize the therapy for the Greater China market. San Diego-based Turning Point could also receive up to $151 million by meeting certain development, regulatory, and sales-based milestones.

Repotrectinib is a small-molecule tyrosine kinase inhibitor of the ROS1, TRK, and ALK genes. Zai Lab's CEO Samantha Du told STAT that repotrectinib is "uniquely positioned" with "strong proof of concept" in patients who have not previously taken a tyrosine kinase inhibitor as well as those who have demonstrated resistance to a TKI.

Zai will be joining the drug's registrational Phase 2 study, called TRIDENT-1, which is currently recruiting patients globally with ROS1-positive advanced non-small cell lung cancer and patients with NTRK-positive solid tumors.

While mutations in the ROS1 gene occur in only about 2% to 3% of patients with advanced non-small cell lung cancer, that still represents more than 30,000 ROS1-positive patients in China per year, a patient pool Zai Lab believes is underserved and holds a significant commercial opportunity.

ROS1-positive patients are commonly treated with Pfizer's Xalkori (crizotinib), the only approved therapy for this type of non-small cell lung cancer in China. But those who develop resistance to the drug quickly run out of options. China has also yet to approve a treatment for patients with cancers with NTRK mutations.

"We believe repotrectinib has a window of opportunity to be the first wave of next-generation ROS1-positive [tyrosine kinase or tropomyosin receptor kinase] inhibitors in the China market," Du said.