Phase 1/2 TRIDENT-1 study data demonstrate
repotrectinib’s clinically meaningful response rates and durable
clinical activity in patients with ROS1-positive non-small cell
lung cancer
Data show robust intracranial activity both in
TKI naïve and pretreated settings in patients with ROS1-positive
NSCLC
Findings demonstrate potential of repotrectinib
to overcome limitations of first-generation TKIs in terms of
durability of responses and activity in ROS1 resistance
mutations
TRIDENT-1 study ongoing globally; Zai Lab
leading execution in Greater China
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced The
New England Journal of Medicine (NEJM) has published data from the
registrational Phase 1/2 TRIDENT-1 study evaluating repotrectinib
(TPX-0005) in patients with ROS1 fusion-positive (ROS1+) non-small
cell lung cancers (NSCLCs). Repotrectinib is a tyrosine kinase
inhibitor (TKI) that has shown robust anti-tumor activity against
ROS1+ cancers in preclinical models. In the TRIDENT-1 study,
repotrectinib demonstrated high response rates and durable activity
in patients with ROS1+ NSCLC, including patients with TKI-naïve and
TKI-pretreated tumors, ROS1 G2032R resistance mutations and brain
metastases. Treatment with repotrectinib was generally well
tolerated with a manageable safety profile compatible with
long-term administration.
Turning Point Therapeutics, a wholly owned subsidiary of the
Bristol-Myers Squibb Company, sponsored and designed the global,
registrational TRIDENT-1 study. In August 2022, Bristol Myers
Squibb acquired the company, including its asset repotrectinib. As
part of its exclusive license agreement with Turning Point
Therapeutics to develop and commercialize repotrectinib in Greater
China (mainland China, Hong Kong, Taiwan, and Macau), Zai Lab
participated and enrolled 81 patients for this trial.
Every year in China, more than 800,000 people are newly
diagnosed with lung cancer, and NSCLC accounts for approximately
85% of the cases. ROS1 rearrangements occur in ≤2% of patients with
NSCLC1. Brain metastases are common among patients with ROS1+ NSCLC
and intracranial activity of approved ROS1 TKIs can be
suboptimal.
“The results from the TRIDENT-1 study suggest repotrectinib
results in high and durable response rates in patients with ROS1+
NSCLC, in the settings of both treatment naïve, treatment
resistant, and intracranial disease, which may address the
limitations of first-generation TKIs,” said Rafael G. Amado, M.D.,
president, head of Global Oncology Research and Development, Zai
Lab. “We look forward to advancing the development of repotrectinib
in Greater China as a next generation treatment in this clinical
setting.”
TRIDENT-1 is a registrational, first-in-human Phase 1/2 study
assessing the efficacy and safety of repotrectinib in patients with
advanced solid tumors, including ROS1+ NSCLC. In the study, 519
patients received one or more doses of repotrectinib, with 103
treated in Phase 1 and 416 treated in Phase 2. Primary endpoints
were maximum tolerated dose (MTD) and/or recommended Phase 2 dose
(RP2D) and confirmed objective response rate (ORR), as assessed by
blinded independent central review (BICR) using RECIST v1.1 (Phase
2). Secondary endpoints included duration of response (DOR),
progression-free survival (PFS) and safety.
Based on the results of this trial, the Center for Drug
Evaluation (CDE) of the National Medical Products Administration
(NMPA) accepted the New Drug Application (NDA) for repotrectinib
submitted by Zai Lab for the treatment of adult patients with
locally advanced or metastatic ROS1-positive NSCLC, after granting
priority review in May 2023. In November 2023, the U.S. Food and
Drug Administration approved repotrectinib for use in adult
patients with locally advanced or metastatic ROS1+ NSCLC in the
United States.
About Repotrectinib
Repotrectinib is a next-generation tyrosine kinase inhibitor
(TKI) targeting the ROS1 and NTRK oncogenic drivers of advanced
solid tumors, including non-small cell lung cancer (NSCLC).
Patients with tumor harboring ROS1 and NTRK gene fusions treated
with approved targeted therapies often develop resistance
mutations, eventually leading to tumor progression. Repotrectinib
is the first next-generation TKI for ROS1-positive metastatic NSCLC
and tumors with NTRK fusions, uniquely designed to address key
drivers of disease progression.
In China, repotrectinib has been granted four Breakthrough
Therapy Designations from the Center for Drug Evaluation (CDE) of
the National Medical Products Administration (NMPA) in
ROS1-positive metastatic NSCLC patients who have not been treated
with a ROS1 TKI; ROS1-positive metastatic NSCLC patients who have
previously been treated with a ROS1 TKI and who have not received
prior platinum-based chemotherapy; ROS1-positive metastatic NSCLC
patients who have previously been treated with a ROS1 TKI and one
prior line of platinum-based chemotherapy; and patients with
advanced solid tumors that have an NTRK gene fusion who have
progressed following treatment with prior TRK tyrosine kinase
inhibitors (TKIs).
Zai Lab has an exclusive license agreement with Turning Point
Therapeutics, a wholly owned subsidiary of the Bristol-Myers Squibb
Company, to develop and commercialize repotrectinib in Greater
China (mainland China, Hong Kong, Taiwan and Macau).
About Zai Lab
Zai Lab (NASDAQ: ZLAB; HKEX: 9688) is an innovative,
research-based, commercial-stage biopharmaceutical company based in
China and the United States. We are focused on discovering,
developing, and commercializing innovative products that address
medical conditions with significant unmet needs in the areas of
oncology, autoimmune disorders, infectious diseases, and
neuroscience. Our goal is to leverage our competencies and
resources to positively impact human health in China and
worldwide.
For additional information about Zai Lab, including our
products, business activities and partnerships, research, and other
events or developments, please visit www.zailaboratory.com or
follow us at www.twitter.com/ZaiLab_Global.
Zai Lab Forward-Looking Statements
This press release contains forward-looking statements about
future expectations, plans, and prospects for Zai Lab, including,
without limitation, statements relating to the prospects of
repotrectinib and the potential treatment of NSCLC and
NTRK-positive solid tumors in Greater China. These forward-looking
statements may contain 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 or 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
obtain funding for our operations and business initiatives, (3) the
results of our 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) risks related to doing business in
China, and (6) other factors identified in our most recent annual
and quarterly reports and in other reports we have filed with the
U.S. Securities and Exchange Commission. We anticipate that
subsequent events and developments will cause our expectations and
assumptions to change, and we undertake no obligation to update or
revise any forward-looking statements, whether as a result of new
information, future events or otherwise, except as may be required
by law. These forward-looking statements should not be relied upon
as representing our views as of any date subsequent to the date of
this press release.
Our SEC filings can be found on our website at
www.zailaboratory.com and on the SEC’s website at www.sec.gov.
_________________________ 1Zhang et al. Prevalence of ROS1
fusion in Chinese patients with non-small cell lung cancer,
Thoracic Cancer January 2019.
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version on businesswire.com: https://www.businesswire.com/news/home/20240110597643/en/
Investor Relations: Christine Chiou / Lina Zhang +1 (917)
886-6929 / +86 136 8257 6943 christine.chiou1@zailaboratory.com /
lina.zhang@zailaboratory.com
Media: Jennifer Chang / Xiaoyu Chen +1 (917) 446 3140 /
+86 185 0015 5011 jennifer.chang@zailaboratory.com /
xiaoyu.chen@zailaboratory.com
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