Zai Lab Announces First Patient Treated in China in the Registrational Phase 2 TRIDENT-1 Study of Repotrectinib
- TRIDENT-1 study is enrolling patients with ROS1+ advanced NSCLC and NTRK+ advanced solid tumors.
“We believe repotrectinib has the potential to be the best-in-class treatment for patients with ROS1+ or NTRK+ tumors, including patients
The registrational Phase 2 portion of TRIDENT-1 study is a multi-center trial evaluating repotrectinib for the treatment of patients with ROS1+ advanced NSCLC as well as patients with NTRK+ advanced solid tumors. The primary endpoint of the Phase 2 portion of the trial is overall response rate (ORR) assessed by Blinded Independent Central Review (BICR). Secondary endpoints include duration of response (DOR), progression free survival (PFS), safety and tolerability.
Turning Point disclosed on
More information about the ongoing TRIDENT-1 study of repotrectinib can be found by searching clinical trial identifier NCT03093116 at https://clinicaltrials.gov.
About Non-Small Cell
Lung cancer is the most commonly diagnosed cancer type and the leading cause of cancer death in
Repotrectinib is a next-generation kinase inhibitor targeting the ROS1 and TRK oncogenic drivers of non-small cell lung cancer and advanced solid tumors. Turning Point Therapeutics is studying repotrectinib in TRIDENT-1, a registrational Phase 1/2 study in adults, and
Tumors with mutations to their ROS1, NTRK and ALK genes have a higher likelihood of developing resistance to existing targeted therapies. In many cases, these mutations prevent existing medicine from targeting and binding to the tumor as effectively as tumors that don’t carry the mutations. Repotrectinib is designed to be smaller and less bulky than existing targeted therapies and may circumvent some the resistance mechanisms found in tumors with ROS1, NTRK and ALK mutations.
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About Turning Point Therapeutics Inc.
Turning Point Therapeutics is a clinical-stage precision oncology company with a pipeline of internally discovered investigational drugs designed to address key limitations of existing cancer therapies. The company’s lead drug candidate, repotrectinib, is a next-generation kinase inhibitor targeting the ROS1 and TRK oncogenic drivers of non-small cell lung cancer and advanced solid tumors. Repotrectinib, which is being studied in a registrational Phase 2 study in adults and a Phase 1/2 study in pediatric patients, has shown antitumor activity and durable responses among kinase inhibitor treatment-naïve and pre-treated patients. The company’s pipeline of drug candidates also includes TPX-0022, targeting MET, CSF1R and SRC, which is being studied in a Phase 1 trial of patients with advanced or metastatic solid tumors harboring genetic alterations in MET; TPX-0046, targeting RET, which is being studied in a Phase 1/2 trial of patients with advanced or metastatic solid tumors harboring genetic alterations in RET; and TPX-0131, a next-generation ALK inhibitor, which is being studied in a Phase 1/2 trial of previously treated patients with ALK-positive advanced or metastatic non-small cell lung cancer. Turning Point’s next-generation kinase inhibitors are designed to bind to their targets with greater precision and affinity than existing therapies, with a novel, compact structure that has demonstrated an ability to potentially overcome treatment resistance common with other kinase inhibitors. The company is driven to develop therapies that mark a turning point for patients in their cancer treatment. For more information, visit www.tptherapeutics.com.
Zai Lab Forward Looking Statements
This press release contains statements about future expectations, plans and prospects for Zai Lab, including, without limitation, statements regarding the prospects and plans for developing and commercializing repotrectinib in Greater China and other statements containing words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would” and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical fact nor are they guarantees or assurances of future performance. Forward-looking statements are based on Zai Lab’s expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) Zai Lab’s ability to successfully commercialize and generate revenue from its approved products; (2) Zai Lab’s ability to finance its operations and business initiatives and obtain funding for such activities, (3) Zai Lab’s results of clinical and pre-clinical development of its product candidates, (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of Zai Lab’s product candidates, (5) the effects of the novel coronavirus (COVID-19) pandemic on our business and general economic, regulatory and political conditions and (6) the risk factors identified in our most recent annual or quarterly report and in other reports we have filed with the
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Source: Zai Lab Limited