- Findings will be shared in oral presentations at the 2024
Congress of the European Society of Gynaecological Oncology (ESGO)
and the 2024 Society for Gynecologic Oncology (SGO) Annual Meeting
on Women’s Cancer -
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that
the final overall survival (OS) data from the Phase 3 randomized,
double-blind, placebo-controlled NORA study evaluating ZEJULA®
(niraparib) in Chinese patients with platinum-sensitive recurrent
ovarian cancer (PSROC) will be shared in oral presentations at the
2024 Congress of the European Society of Gynaecological Oncology
(ESGO), March 7-10, 2024, in Barcelona, Spain, and the 2024 Society
for Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer,
taking place March 16-18, 2024, in San Diego, CA.
“Previous progression-free survival and interim OS data from the
NORA study demonstrated the benefit of niraparib maintenance
therapy with an individualized starting dose among Chinese patients
with PSROC,” said Dr. Rafael Amado, President, Head of Global
Oncology Research and Development, Zai Lab. “We look forward to
sharing the final OS findings from this study at both the 2024 ESGO
and SGO conferences. Based on these results, ZEJULA remains the
only PARP inhibitor approved as maintenance monotherapy for ovarian
cancer patients in both first-line and recurrent settings
regardless of biomarker status.”
In the NORA study, 265 patients with PSROC were randomized (2:1)
to receive niraparib or placebo. The final OS analysis was
conducted after ≥ 50% of OS events occurred in the intent-to-treat
population. The ESGO presentation will feature data analyses
showing that niraparib maintenance therapy with an individualised
starting dose (ISD) based on patient weight and platelet count
demonstrated a favorable OS trend versus placebo in this disease
setting, regardless of BRCA-gene mutation status. No new safety
signals were identified during the long-term follow up period
subsequent to the primary analysis.
Details regarding the oral presentation at the 2024 ESGO
Congress are as follows:
Title: Niraparib maintenance therapy using an
individualised starting dose in patients with platinum-sensitive
recurrent ovarian cancer (NORA): Final overall survival analysis of
a randomised, double-blind, placebo-controlled phase 3 trial
Presenter: Xiaohua Wu, M.D., PhD., Fudan University Shanghai
Cancer Center, Shanghai, China Date/Time: Saturday, March 9,
2024, 4:13 p.m. – 4:19 p.m. CET/Spain Location: Session Hall
III (112)
Details regarding the late-breaking oral presentation at the
2024 SGO Annual Meeting are as follows:
Title: Niraparib maintenance therapy using an
individualized starting dose in patients with platinum-sensitive
recurrent ovarian cancer (NORA): Final overall survival analysis of
a randomized, double-blind, placebo-controlled phase 3 trial
Presenter: Xiaohua Wu, M.D., PhD., Fudan University Shanghai
Cancer Center, Shanghai, China Date/Time: Monday, March 18,
2024, 3:24 p.m. to 3:30 p.m. Pacific Time Location: San
Diego Convention Center, Hall F
About Ovarian Cancer Ovarian cancer is one of the most
common gynecologic cancers in China with more than 55,000 newly
diagnosed cases and 37,000 deaths each year. 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 inevitable relapse of
ovarian cancer will benefit patients with ovarian cancer in
China.
About ZEJULA (niraparib) ZEJULA (niraparib) is an oral,
once-daily small-molecule poly (ADP-ribose) polymerase (PARP) 1/2
inhibitor. A PARP inhibitor blocks the ability of cancer cells to
repair themselves after they have been damaged by radiation and
certain chemotherapies. This inhibition of DNA damage repair can
result in the inability of cancer cells to replicate themselves and
in programmed cell death. Tumors that are deficient in key DNA
damage repair pathways, such as BRCA1 mutant tumors, are
particularly sensitive to ZEJULA. As maintenance therapy, ZEJULA is
for women who have had prior chemotherapy treatment but are at high
risk of cancer recurrence. ZEJULA is intended to avoid or slow a
recurrence of the cancer if it is in remission after prior
treatment. In the maintenance setting, ZEJULA does not require the
addition of radiation or chemotherapies to kill tumor cells.
As a first-line monotherapy maintenance treatment of patients
with epithelial ovarian, fallopian tube, or primary peritoneal
cancer (collectively, ovarian cancer) following a response to
platinum-based chemotherapy, ZEJULA was approved by the NMPA in
September 2020 and included in the NRDL in December 2021.
As a maintenance treatment of patients with platinum sensitive
recurrent ovarian cancer, ZEJULA was approved by the NMPA in
December 2019 and included in the NRDL in December 2020.
Zai Lab has an exclusive license from GSK to develop and
commercialize ZEJULA in mainland China, Hong Kong, 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, please visit
www.zailaboratory.com or follow us at
www.twitter.com/ZaiLab_Global.
Zai Lab Forward-Looking Statements
This press release contains statements about future
expectations, plans and prospects for Zai Lab, including, without
limitation, statements relating to the benefits of ZEJULA and the
treatment of ovarian cancer in 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 drug
candidates, (4) the content and timing of decisions made by the
relevant regulatory authorities regarding regulatory approvals of
our drug candidates, (5) risks related to doing business in China;
and (6) other factors discussed 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.
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For more information:
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 (857) 270-8985/
+86 185 0015 5011 jennifer.chang@zailaboratory.com /
xiaoyu.chen@zailaboratory.com
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