Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that
JAMA Oncology published data from the pivotal Phase 3 PRIME study
evaluating ZEJULA® (niraparib) as a first-line maintenance therapy
in Chinese patients with newly diagnosed advanced ovarian cancer.
These data demonstrate that maintenance treatment with ZEJULA
significantly prolongs progression-free survival (PFS) versus
placebo and reduces the risk of disease progression or death by
55%. These findings are consistent with prior studies that indicate
that front-line maintenance therapy with ZEJULA can provide
statistically and clinically meaningful benefit in a broad
population of patients, regardless of postoperative residual
disease or biomarker status.
“Women with advanced ovarian cancer have a poor prognosis, with
a global 5-year survival rate of less than 50 percent and a
recurrence rate of approximately 75 percent,” said Rafael G. Amado,
M.D., President, Head of Global Oncology Research and Development
at Zai Lab. “The positive results from the PRIME study, which show
a substantial reduction in risk of disease progression or death
with ZEJULA maintenance, offer insights into the potential to delay
the progression of this devastating disease in a broad group of
patients. We look forward to continuing to work with our partners
to improve outcomes for women living with ovarian cancer.”
The PRIME study is a Phase 3, randomized, double-blind,
placebo-controlled clinical trial conducted at 29 hospitals in
mainland China. The study evaluated the use of ZEJULA, a potent,
highly selective PARP 1 and PARP 2 inhibitor, as first-line
maintenance therapy among 384 patients with newly diagnosed
advanced ovarian cancer who had received first-line platinum-based
chemotherapy and had a complete response or partial response,
including patients who underwent debulking surgery to remove all
tumor (R0 resection). The primary endpoint was blinded independent
central review (BICR)-assessed PFS in the intention-to-treat
population (ITT). Patients in the study were randomized 2:1 to
receive ZEJULA or placebo. Patients receiving ZEJULA received an
individual starting dose (ISD) of 200 or 300 mg based on baseline
bodyweight and platelet count.
The JAMA Oncology PRIME publication includes the following key
efficacy and safety findings:
- ZEJULA significantly
extended PFS versus placebo and reduced the risk of disease
progression or death by 55%, regardless of postoperative residual
disease or biomarker status.
- Median PFS (mPFS)
with ZEJULA versus placebo in the ITT population was 24.8 versus
8.3 months (hazard ratio [HR], 0.45; 95% CI, 0.34–0.60;
p<.001).
- At the time of data
cut-off, overall survival (OS) data were not yet mature in the
ITT population.
- Utilization of an ISD demonstrated a tolerable safety profile
in the maintenance setting.
- Grade ≥3 treatment-emergent adverse events (TEAEs) and serious
adverse events (SAEs) were reported in 54.5% versus 17.8% and 18.8%
vs 8.5% in ZEJULA-treated and placebo-treated patient
respectively.
- Similar proportions of ZEJULA-treated and placebo-treated
patients (6.7% vs 5.4%) discontinued therapy due to TEAEs.
Additional sub-analyses consistently demonstrated that ZEJULA
improved PFS versus placebo in a broad range of patients:
- PFS not reached versus 10.8 months in
patients with the gBRCA mutation (HR, 0.40; 95% CI, 0.23-0.68)
- 19.3 versus 8.3 months in patients without the gBRCA mutation
(HR, 0.48; 95% CI, 0.34-0.67)
- 24.8 versus 8.3 months in patients with optimal debulking (HR,
0.44; 95% CI, 0.32-0.61)
- 16.5 versus 8.3 months in patients with suboptimal debulking
(HR, 0.27; 95% CI, 0.10–-0.72)
“The complexity of ovarian cancer demands multiple, innovative
treatment options,” said Lead Author Dr. Lingying Wu. “These
data from the PRIME study prospectively demonstrate that an ISD of
200 or 300 mg of ZEJULA based on baseline bodyweight and platelet
count can bring significant benefit to patients with an improved
safety and tolerability profile of ZEJULA compared to a fixed 300
mg starting dose in previous studies, and further support the use
of an ISD to improve patient outcomes in clinical practice.”
Dr. Wu is Director of the Department of Gynecologic
Oncology, National Cancer Center / National Clinical
Research Center for Cancer / Cancer Hospital, Chinese
Academy of Medical Sciences and Peking Union Medical
College.
Zai Lab has a license and collaboration agreement with Tesaro,
Inc. (a company later acquired by GSK) for the development and
commercialization of ZEJULA (independently manufactured by Zai Lab)
in mainland China, Hong Kong, and Macau.
About Ovarian Cancer
Ovarian cancer is one of the most common gynecologic cancers in
China, with over 55,000 newly diagnosed cases and 37,000 deaths in
China annually.i While platinum-based chemotherapy is effective at
inducing an initial response in ovarian cancer, the disease will
recur in the majority of women. New agents that prolong the
duration of response following platinum-based treatment and delay
the relapse of ovarian cancer will benefit patients with ovarian
cancer in China.
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 platinum
sensitive recurrent epithelial ovarian, fallopian tube, or primary
peritoneal cancer who are in response (complete or partial) to
first- and second-and further line platinum-based chemotherapy.
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 regarding the prospects and plans
for ZEJULA in mainland China, Hong Kong, and Macau and related
clinical trials, the safety and efficacy of ZEJULA, and the
potential treatment of patients with ovarian cancer. 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 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:
Investor Relations:Christine
Chiou / Lina Zhang+1 (917) 886-6929 / +86 136 8257
6943christine.chiou1@zailaboratory.com / lina.zhang@zailaboratory.com
Media:Shaun Maccoun / Xiaoyu Chen+1
(415) 317-7255 / +86 185 0015
5011shaun.maccoun@zailaboratory.com / xiaoyu.chen@zailaboratory.com
______________________________i Globocan 2020
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