Zai Lab and Turning Point Therapeutics Announce Topline Analysis in China Subpopulation for Repotrectinib in ROS1-Positive NSCLC Cohorts Within Global Phase 1/2 TRIDENT-1 Study
- 91% confirmed objective response rate (cORR) (10/11) in
Chinasubpopulation by Blinded Independent Central Review (BICR) in TKI-naïve cohort (EXP-1)
- In the TKI-naïve
Chinasubpopulation by BICR, the duration of response (DOR) range was 3.6+-7.5+ months with median DOR follow-up of 3.7 months
- 36-67% cORR by BICR in
Chinasubpopulation across three TKI-pretreated cohorts (EXP-2, EXP-3, and EXP-4) Zai Labplans to discuss topline TKI-naïve data with Chinese health authority in the fourth quarter of 2022
“With over 800,000 newly diagnosed lung cancer patients every year in
“We are incredibly pleased with our collaboration with
The primary objective of the TRIDENT-1 study is to determine the cORR based on BICR as assessed by RECIST 1.1. DOR is a key secondary objective of the study. The dataset utilizes a
Topline Efficacy Analyses by BICR
- In TKI-naïve patients (EXP-1), in 71 total patients, there was a cORR of 79% across the global trial. Ten of 11 patients responded within
Chinafor a cORR of 91% (95% CI: 59,100) and DOR ranged from 3.6+ to 7.5+ months with a median duration of follow-up of 3.7 months.
- In patients previously treated with 1 TKI and platinum-based chemotherapy (EXP-2), in 26 total patients, there was a cORR of 42% across the global trial. Two of 3 patients responded within
Chinafor a cORR of 67% (95% CI:9,99) and DOR ranged from 3.6+ to 3.7+ months with a median duration of follow-up of 3.7 months.
- In patients previously treated with two TKIs without prior chemotherapy (EXP-3), in 18 total patients, there was a cORR of 28% across the global trial. Two of 4 patients responded within
Chinafor a cORR of 50% (95% CI: 7,93) and DOR ranged from 1.9+ to 3.4+ months with a median duration of follow-up of 2.6 months.
- In patients previously treated with 1 TKI without prior chemotherapy (EXP-4), in 56 total patients, there was a cORR of 36% across the global trial. Four of 11 patients responded within
Chinafor a cORR of 36% (95% CI: 11,69) and DOR ranged from 2.0+ to 3.7+ months with a median duration of follow-up of 3.1 months.
Global TRIDENT-1 Topline Safety Analyses
Repotrectinib was generally well tolerated in a total of 380 patients treated globally with a safety and tolerability profile that was consistent with previously reported findings. The most commonly reported treatment emergent adverse event remained dizziness (61% all grade), of which 76% of patients who reported dizziness had a maximum severity of grade 1. The safety profile was comparable among the 287 patients who were treated at the Phase 2 dose.
The TRIDENT-1 study continues to enroll patients globally across the study. As previously guided,
About Zai Lab
Zai Lab Forward-Looking Statements
This press release contains forward-looking statements about results from the global TRIDENT-1 study, the identification and treatment of lung cancer, the efficacy, safety and therapeutic potential of repotrectinib, including the belief that repotrectinib is a potentially best-in-class drug candidate across all ROS1-positive NSCLC indications, data readouts and presentations for repotrectinib, and risks and uncertainties regarding drug development, regulatory approval and commercialization. .. These forward-looking statements include, without limitation, 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 our 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) our ability to successfully commercialize and generate revenue from our approved products; (2) our ability to finance our operations and business initiatives and obtain funding for such activities, (3) our results of clinical and pre-clinical development of our product candidates, (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of our 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
Turning Point Therapeutics Forward Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “plans”, “will”, “believes,” “anticipates,” “expects,” “intends,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. Such forward-looking statements include statements regarding, among other things, the belief that repotrectinib is a potentially best-in-class drug candidate across all ROS1-positive NSCLC indications, anticipated timing for a pre-NDA meeting with the FDA regarding the topline BICR data for repotrectinib, the anticipated timing and plans for presenting detailed study results from the TRIDENT-1 trial at an upcoming medical conference, the efficacy, safety and therapeutic potential of repotrectinib, plans regarding future regulatory submissions, and the regulatory approval path for repotrectinib. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon Turning Point Therapeutics’ current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with Turning Point Therapeutics’ business in general, risks and uncertainties related to the impact of the COVID-19 pandemic to Turning Point Therapeutics’ business and the other risks described in Turning Point Therapeutics’ filings with the
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Source: Zai Lab Limited