The approval is based on the pivotal TRIDENT-1
trial, in which AUGTYRO achieved a high response rate and durable
responses, including robust intracranial responses
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that
the National Medical Products Administration (NMPA) in China has
approved the New Drug Application (NDA) for AUGTYRO™
(repotrectinib) for the treatment of adult patients with locally
advanced or metastatic ROS1-positive non-small-cell lung cancer
(NSCLC). The approval is based on the pivotal TRIDENT-1 study, an
open-label, single-arm, Phase 1/2 trial that evaluated
repotrectinib in TKI-naïve and TKI-pretreated patients with
ROS1-positive NSCLC.
“We are pleased with NMPA’s approval of AUGTYRO for the
treatment of patients with ROS1-positive NSCLC in China. There is a
significant unmet need for these patients given the limited
durability of benefit due to the emergence of resistance with
existing therapies, eventually leading to tumor progression,” said
Rafael G. Amado, M.D., President, Head of Global Oncology Research
and Development at Zai Lab. “We appreciate the NMPA for their
thorough assessment of AUGTYRO, recognizing its potential to
address the unmet medical need in China.”
“Despite existing earlier generation TKIs for ROS1-positive
NSCLC, there remains an unmet need for new treatment options that
support important clinical goals, such as durable therapeutic
response,” said Dr. Shun Lu, M.D., Ph.D., Chief of Lung Cancer
Center, Shanghai Chest Hospital, Shanghai Jiaotong University. “The
TRIDENT-1 study showed that treatment with repotrectinib results in
high response rates with promising durability in patients with
ROS1-positive NSCLC, across TKI-naïve and TKI-pretreated settings,
including in the presence of intracranial disease. Based on this
study, repotrectinib has the potential to become a new standard of
care for these patients.”
In June 2023, China’s NMPA accepted the NDA for AUGTYRO for the
treatment of adult patients with locally advanced or metastatic
ROS1-positive NSCLC, with priority review granted in May 2023.
Zai Lab contributed to the pivotal TRIDENT-1 study and dosed the
first patient in Greater China in May 2021, and the results were
published in the New England Journal of Medicine in January 2024.
The topline efficacy and safety data of Chinese subpopulation is
consistent with that of global population, demonstrating robust
response rates and durable clinical activity in patients with
ROS1-positive NSCLC. Treatment with AUGTYRO was generally well
tolerated with a manageable safety profile.
About AUGTYRO
AUGTYRO (repotrectinib) is a next-generation tyrosine kinase
inhibitor targeting the ROS1 and NTRK oncogenic drivers. Patients
with solid tumors, including NSCLC, harboring ROS1 and NTRK gene
fusions treated with approved targeted therapies often develop
resistance mutations that limit binding of these drugs to their
target. Ultimately, this leads to shortened duration of response
and tumor progression. AUGTYRO is the first next-generation ROS1
and TRK TKI uniquely designed to improve durability of benefit,
including in the brain.
In November 2023, AUGTYRO was approved by the U.S. Food and Drug
Administration (FDA) for the treatment of adult patients with
locally advanced or metastatic ROS1-positive NSCLC.
AUGTYRO has been granted three Breakthrough Therapy Designations
from the U.S. Food and Drug Administration 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 one ROS1 TKI and who have not received prior
platinum-based chemotherapy; and patients with advanced solid
tumors that have an NTRK gene fusion who have progressed following
treatment with one or two prior TRK TKIs, with or without prior
chemotherapy, and have not had satisfactory alternative treatments.
Additionally, AUGTYRO was previously granted four Fast-Track
designations in patients with: ROS1-positive advanced NSCLC who
have not been treated with one ROS1 TKI; ROS1-positive advanced
NSCLC who have been previously treated with one prior line of
platinum-based chemotherapy and one prior ROS1 TKI; ROS1-positive
advanced NSCLC pretreated with one prior ROS1 TKI without prior
platinum-based chemotherapy; and advanced solid tumors that have an
NTRK gene fusion who have progressed following treatment with at
least one prior line of chemotherapy and one or two prior TRK TKIs
and have not had satisfactory alternative treatments. AUGTYRO was
also granted an Orphan Drug designation in 2017.
AUGTYRO has been granted four Breakthrough Therapy Designations
by the CDE of China’s 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 one
prior ROS1 TKI and who have not received prior platinum-based
chemotherapy or immunotherapy; and ROS1-positive metastatic NSCLC
patients who have previously been treated with one prior ROS1 TKI
and one platinum-based chemotherapy; and patients with advanced
solid tumors that have an NTRK gene fusion who have progressed
following treatment with one or two prior TRK TKIs, with or without
prior chemotherapy, and have not had satisfactory alternative
treatments.
Zai Lab has an exclusive license agreement with Turning Point
Therapeutics, Inc. (Turning Point Therapeutics, a Bristol Myers
Squibb company) to develop and commercialize AUGTYRO in Greater
China (Mainland China, Hong Kong, Taiwan, and Macau).
About TRIDENT-1
TRIDENT-1 is a global, multicenter, single-arm, open-label,
multi-cohort Phase 1/2 clinical trial evaluating the safety,
tolerability, pharmacokinetics and anti-tumor activity of AUGTYRO
in patients with advanced solid tumors, including NSCLC.1,2 Phase
1/2 includes patients with locally advanced or metastatic solid
tumors harboring ROS1 fusions.2 Additional analyses of the trial
are still being conducted; asymptomatic central nervous system
(CNS) metastases are allowed.1,2 The trial excludes patients with
symptomatic brain metastases, among other exclusion criteria.1
Phase 1 of the trial included the dose escalation that determined
the recommended Phase 2 dose.2
Phase 2 of the trial has a primary endpoint of overall response
rate (ORR).1,2 Key secondary endpoints include duration of response
(DOR) according to Response Evaluation Criteria in Solid Tumors
(RECIST v1.1) as assessed by Blinded Independent Central Review
(BICR), progression-free survival (PFS), and intracranial response
in six distinct expansion cohorts, including TKI-naïve and
TKI-pretreated patients with ROS1-positive locally advanced or
metastatic NSCLC.1,2
In TRIDENT-1, 79% (95% Confidence Interval [CI]: 68 to 88) of
TKI-naïve patients (n=71) responded to treatment; 6% experienced
complete responses and 73% experienced partial responses.1 The
median duration of response (mDOR) was 34.1 months.1 Among
TKI-pretreated patients, 38% (95% CI: 25 to 52) (n=56) responded to
treatment; 5% experienced complete responses and 32% experienced
partial responses and the mDOR was 14.8 months.1 Among those who
had measurable CNS metastases at baseline, responses in
intracranial lesions were observed in 7 of 8 TKI-naïve patients and
in 5 of 12 of those who were TKI-pretreated.1
The FDA-approved dosing for AUGTYRO is 160 mg orally once daily
for 14 days, then increased to 160 mg twice daily until disease
progression or unacceptable toxicity.1
About Non-Small Cell Lung Cancer in China
Lung cancer is the most commonly diagnosed cancer type and the
leading cause of cancer death in China. There were approximately
871,000 new cases and 767,000 deaths of lung cancer in China in
2022, respectively.3 NSCLC accounts for approximately 85% of lung
cancer, and approximately 70% of NSCLC is locally advanced or
metastatic at initial diagnosis. In China, ROS1 rearrangements
occur in 2-3% of patients with advanced NSCLC.4
1 Augtyro Prescribing Information. Augtyro U.S. Product
Information. Last updated: November 2023. Princeton, NJ: Bristol
Myers Squibb Company. 2 ClinicalTrials.gov: NCT03093116. A study of
repotrectinib (TPX-0005) in patients with advanced solid tumors
harboring ALK, ROS1, or NTRK1-3 rearrangements (TRIDENT-1).
Available at
https://classic.clinicaltrials.gov/ct2/show/NCT03093116. Accessed
November 4, 2023. 3 Changfa Xia, et al. Cancer statistics in China
and United States, 2022: profiles, trends, and determinants. 4
Zhang, et al. Prevalence of ROS1 fusion in Chinese patients with
non-small cell lung cancer, Thoracic Cancer January 2019.
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, 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 ROS1-positive 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.
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For more information, please contact:
Investor Relations: Christine Chiou / Lina Zhang
+1 (917) 886-6929 / +86 136 8257 6943
christine.chiou1@zailaboratory.com /
lina.zhang@zailaboratory.com
Shaun Maccoun / Xiaoyu Chen +1 (857) 270-8854 / +86 185 0015
5011 shaun.maccoun@zailaboratory.com /
xiaoyu.chen@zailaboratory.com
Zai Lab (NASDAQ:ZLAB)
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