NEW YORK – Zai Lab on Friday began the Phase II TRIDENT-1 study in China of repotrectinib in ROS1-mutated advanced non-small cell lung cancer and NTRK-positive advanced solid tumors.
The trial is being run by Shanghai-based Zai for Turning Point Therapeutics. Last summer, Zai entered into an exclusive license agreement with Turning Point to develop and commercialize repotrectinib in China, Hong Kong, Macau, and Taiwan.
The primary endpoint of the registrational study is overall response rate, and researchers will also evaluate duration of response, progression free survival, safety, and tolerability.
"Tumors with fusions in their ROS1 and NTRK genes have a high likelihood of developing resistance to existing targeted therapies," Alan Sandler, president and head of global development for oncology at Zai Lab, said in a statement. "In many cases, these acquired resistance mutations prevent existing medicine from binding to the tumor as effectively as to tumors that don't carry these resistance mutations. We are excited to announce the expansion of the TRIDENT-1 study into China and to support our partner Turning Point Therapeutics in bringing a potential best-in-class therapy to patients globally."
In January, Turning Point said it planned to discuss interim data from the TRIDENT-1 study in ROS1-positive NSCLC patients with the US Food and Drug Administration. The firm said the FDA noted that the data could be discussed once responders have been followed for at least six months after the onset of response. Turning Point expects to have that data in the first quarter of 2022.
In early data presented last summer, the study showed an objective response rate of 86 percent for ROS1-positive, TKI-naive patients with NSCLC and a response rate of 50 percent for pretreated patients with NTRK-positive solid tumors.
This year, Zai entered into another license agreement with Turning Point to develop its MET, SRC, and CSF1R inhibitor, TPX-0022, in Greater China.