Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) will present three
poster presentations with new data, including preliminary results
from a clinical study evaluating its internal oncology research and
development program ZL-1211, at the 2023 American Society of
Clinical Oncology (ASCO) Annual Meeting. ZL-1211 is an anti-Claudin
(CLDN) 18.2 monoclonal antibody currently being evaluated for the
treatment of unresectable or metastatic solid tumors.
“We have been steadily expanding our oncology
pipeline to include in-house research and development programs that
are designed to reach patients globally, and we are pleased to
share initial findings from our ZL-1211 program at this year’s ASCO
meeting,” said Rafael Amado, MD, President, Head of Global Oncology
Research and Development, Zai Lab. “Patients with advanced and
refractory solid tumors require expanded treatment options, and we
are committed to becoming an integral part of this treatment
landscape.”
ZL-1211 is an anti-CLDN18.2 antibody that targets
CLDN18.2 to induce cancer cell death through antibody-dependent
cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity
(CDC). This report will highlight preliminary results from the
ongoing dose-escalation portion of a first-in-human, Phase 1/2,
multicenter study of ZL-1211 administered intravenously to adults
with CLDN18.2-positive advanced solid tumors (Poster #379). The
first phase of the study aims to assess the single agent safety,
tolerability, and early anti-tumor activity of ZL-1211 in patients
with unresectable or metastatic solid tumors, as well as to
determine the maximum tolerated dose (MTD) and recommended Phase 2
dose of ZL-1211 in this patient population.
Among the 10 evaluable patients included in the
data analysis, the results showed ZL-1211 demonstrated a tolerable
safety profile and preliminary antitumor effects. For example:
- There were no dose limiting toxicities (DLTs) as of the data
cut-off date.
- The most common treatment-related adverse events (TRAEs) were
gastrointestinal (GI) disorders, including nausea, vomiting, and
abdominal pain.
- Six patients achieved stable disease with three patients having
some evidence of tumor regression.
Researchers will also present results from a post
hoc sub-group analysis from the PRIME study, which explored the
efficacy and safety of niraparib maintenance therapy among Chinese
patients with advanced ovarian cancer who had measurable residual
disease after first-line platinum-based chemotherapy (Poster #257).
The data indicate that, in these patients, niraparib maintenance
therapy tended to induce additional antitumor activity and led to a
clinically meaningful increase in progression free survival (PFS)
versus placebo. Zai Lab has a collaboration and license agreement
with GSK for the development and commercialization of ZEJULA®
(niraparib) in Greater China (mainland China, Hong Kong and
Macau).
Zai Lab’s third presentation (Poster #477) will
provide a long-term update to the Phase 2 trial evaluating the
efficacy and safety of ripretinib as fourth-line (or beyond)
therapy in a single arm study of Chinese patients with advanced
gastrointestinal stromal tumors (GIST). The long-term follow up
results continue to support the clinically meaningful benefit in
PFS, which is comparable to results seen in the global randomized
INVICTUS trial, and demonstrate clinically meaningful overall
survival (OS) in Chinese ≥4L GIST patients, while the safety
profile remains acceptable. Zai Lab has a licensing agreement with
Deciphera for the development and commercialization of QINLOCK®
(ripretinib) in Greater China (mainland China, Hong Kong, Macau and
Taiwan).
Details regarding the Zai Lab presentations at the
2023 ASCO meeting are as follows:
Title: |
Preliminary results of a phase 1/2, first-in-human, open-label,
dose escalation study of ZL-1211 (anti-Claudin 18.2 mAb) in
patients with unresectable or metastatic solid tumors |
Abstract #: |
2537 (Poster #379) |
Presenter: |
Sunil Sharma, MD, Honor
Health |
Date/Time: |
Saturday, June 3, 8:00 a.m.
CT |
Location: |
McCormick Place, Hall A |
Abstract link: |
https://meetings.asco.org/abstracts-presentations/221710 |
|
|
Title: |
Efficacy and safety of ripretinib
in Chinese patients with advanced gastrointestinal stromal tumors
(GIST) as ≥4th line therapy: Long-term update from a single-arm,
phase 2 trial. |
Abstract #: |
11543 (Poster #477) |
Presenter: |
Jian Li, DPhil, Peking University
Cancer Hospital & Institute |
Date/Time: |
Saturday, June 3, 1:15 p.m.
CT |
Location: |
McCormick Place, Hall A |
Abstract link: |
https://meetings.asco.org/abstracts-presentations/220669 |
|
|
Title: |
Efficacy and safety of niraparib
maintenance therapy in patients with newly diagnosed advanced
ovarian cancer who had measurable residual disease: A post-hoc
subgroup analysis of the PRIME study |
Abstract #: |
5562 (Poster #257) |
Presenter: |
Beihua Kong, MD, Qilu Hospital of
Shandong University |
Date/Time: |
Monday, June 5, 1:15 p.m. CT |
Location: |
McCormick Place, Hall A |
Abstract link: |
https://meetings.asco.org/abstracts-presentations/223034 |
|
|
About the PRIME Study
The fully powered Phase 3 PRIME study was evaluated
in 384 advanced ovarian cancer patients who were in a complete or
partial response to platinum-based chemotherapy and who were
randomized 2:1 to receive ZEJULA or placebo as maintenance therapy.
The study evaluated the efficacy of ZEJULA as a maintenance
treatment, with the primary endpoint of PFS as assessed by blinded
independent central review. The starting dose was individualized at
200 mg except for those patients with a baseline body weight ≥77kg
and a platelet count ≥150K/μL, in which case the starting dose was
300 mg.
About ZEJULA (niraparib)
ZEJULA (niraparib) is an oral, once-daily poly
(ADP-ribose) polymerase (PARP) inhibitor indicated as monotherapy
for the maintenance treatment of adult patients with advanced and
recurrent epithelial ovarian, fallopian tube, or primary peritoneal
cancer who are in response (complete or partial) to first- and
second-line platinum-based chemotherapy.In addition to the PRIME
study, Zai Lab has completed several studies in Chinese
patients with ovarian cancer:
- In September 2020, Zai Lab announced that ZEJULA
demonstrated a significant PFS benefit with an improved safety
profile in the company’s Phase 3 NORA study of ZEJULA as
maintenance therapy for Chinese patients with platinum-sensitive,
recurrent ovarian cancer, regardless of biomarker status.
- A Phase 1 pharmacokinetic study of ZEJULA was conducted in
Chinese patients with ovarian cancer.
Zai Lab has a collaboration and license
agreement with GSK for the development and commercialization of
ZEJULA (independently manufactured by Zai Lab) in mainland
China, Hong Kong, and Macau.
About the INVICTUS Phase 3
Study
INVICTUS is a Phase 3 randomized, double-blind,
placebo-controlled, international, multicenter clinical study
evaluating the safety, tolerability, and efficacy of QINLOCK
compared to placebo in patients with advanced GIST whose previous
therapies have included imatinib, sunitinib, and regorafenib.
Patients were randomized 2:1 to either 150 mg of QINLOCK or placebo
once daily. The primary efficacy endpoint is progression-free
survival (PFS) as determined by independent radiologic review using
modified Response Evaluation Criteria in Solid Tumors (RECIST). The
median PFS in the study was 6.3 months compared to 1.0 month in the
placebo arm and significantly reduced the risk of disease
progression or death by 85% (hazard ratio of 0.15, p<0.0001).
Secondary endpoints include objective response rate (ORR) as
determined by independent radiologic review using modified RECIST
and overall survival (OS). QINLOCK demonstrated an ORR of 9.4%
compared with 0% for placebo (p =0.0504). QINLOCK also demonstrated
a median OS of 15.1 months compared to 6.6 months in the placebo
arm and reduced the risk of death by 64% (hazard ratio of
0.36).
About QINLOCK (ripretinib)
QINLOCK is a switch-control tyrosine kinase
inhibitor that was engineered to broadly inhibit KIT and PDGFRα
mutated kinases by using a dual mechanism of action that regulates
the kinase switch pocket and activation loop. QINLOCK inhibits
primary and secondary KIT mutations in exons 9, 11, 13, 14, 17, and
18 involved in GIST, as well as the primary exon 17 D816V mutation.
QINLOCK also inhibits primary PDGFRα mutations in exons 12, 14, and
18, including the exon 18 D842V mutation, involved in a subset of
GIST.
QINLOCK is currently approved in 13 territories
around the world, including major markets of the United States,
Europe, and China for the treatment of fourth-line GIST. Zai Lab
has an exclusive license agreement with Deciphera for the
development and commercialization of ripretinib in Greater China
(mainland China, Hong Kong, Macau and Taiwan).
About Zai Lab
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) is an
innovative, research-based, commercial-stage biopharmaceutical
company based in China and the United States focused on bringing
transformative medicines for oncology, autoimmune disorders,
infectious diseases, and neurological disorders to patients in
China and around the world. Our goal is to leverage our
competencies and resources to positively impact human health
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 relating to our future expectations, plans, and
prospects, including, without limitation, statements about ZL-1211,
niraparib, and ripretinib; related clinical trials, data readouts
and presentations, and potential treatments for patients with
unresectable solid tumors, ovarian cancer, and gastrointestinal
tumors. 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 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) the
effects of the novel coronavirus (COVID-19) pandemic on our
business and results of operations, (6) risks related to doing
business in China, and (7) 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 (SEC). 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.
For more information, please
contact:
Media: Jennifer Chang / Xiaoyu
Chen+1 917 446 3140 / +86 185 0015
5011jennifer.chang@zailaboratory.com /
xiaoyu.chen@zailaboratory.com
Investor Relations: Christine
Chiou / Lina Zhang+1 (917) 886-6929 / +86 136 8257
6943christine.chiou1@zailaboratory.com /
lina.zhang@zailaboratory.com
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