- Improved overall survival (OS), progression-free survival (PFS)
and confirmed objective response rate (ORR) were observed in the
China subpopulation treated with TIVDAK compared to chemotherapy,
consistent with those in the global population
- The safety profile of TIVDAK among the China subpopulation was
manageable and consistent with that observed in the global
population
- Zai Lab intends to submit a New Drug Application (NDA) to
China’s National Medical Products Administration (NMPA) in the
first quarter of 2025
- Zai Lab will leverage its commercial footprint of ZEJULA in
women’s cancer to bring the medicine to patients in China if
approved
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced
positive topline results from the China subpopulation of the global
Phase 3 innovaTV 301 study, demonstrating a clinically meaningful
improvement in overall survival with TIVDAK treatment for patients
with previously treated recurrent or metastatic cervical cancer
compared to chemotherapy.
The China subpopulation results were consistent with those in
the global population:
- TIVDAK demonstrated a 45% reduction in the risk of death
compared to chemotherapy (HR: 0.55 [95% CI: 0.27-1.15] in the China
subpopulation who had received prior standard systemic therapies,
with more than half of this Chinese population having received
prior anti-PD(L)1 therapy. Median OS for patients treated with
TIVDAK was not reached versus chemotherapy 10.7 months [95% CI:
6.0-not reached] with a median follow-up of 11.5 months.
- Secondary endpoints of PFS and confirmed ORR also favored
treatment with TIVDAK compared to chemotherapy.
- The safety profile of TIVDAK in the China subpopulation was
manageable and consistent with the global profile.
“Recurrent or metastatic cervical cancer remains a significant
challenge for patients, highlighting a critical unmet need for
effective treatments that extend survival after relapse,” said Dr.
Rafael Amado, M.D., President, Head of Global Research and
Development at Zai Lab. “The consistent and positive results in the
China subpopulation of the global Phase 3 study reinforce the
potential for TIVDAK, the only ADC therapy in this disease setting,
to increase options in this therapeutically unmet clinical setting.
If approved, we expect TIVDAK to add to ZEJULA and augment our
commercial franchise in women’s tumors.”
“There are approximately 150,000 new cases of cervical cancer
annually in China1, and patients face limited treatment options
once their cancer recurs or spreads after initial treatment,” said
Dr. Lingying Wu, Professor of the Department of Gynecologic
Oncology of National Cancer Center / Cancer Hospital Chinese
Academy of Medical Sciences. “While the recent adoption of
immunotherapy as a first-line treatment in China represents
progress, there is a lack of effective options for patients
following relapse. The promising results from TIVDAK, which
demonstrated superior survival extension in patients whose disease
progressed after initial treatments, including prior anti-PD(L)1
treatment, offer hope for addressing this critical unmet need.”
In April 2024, the U.S. Food and Drug Administration (FDA)
approved the supplemental Biologics License Application (sBLA)
granting full approval for TIVDAK® (tisotumab vedotin-tftv) for the
treatment of patients with recurrent or metastatic cervical cancer
with disease progression on or after chemotherapy. The approval was
based on results from the global, randomized, Phase 3 innovaTV 301
clinical trial (NCT04697628), which met its primary endpoint,
demonstrating overall survival (OS) benefit in adult patients with
previously treated recurrent or metastatic cervical cancer treated
with TIVDAK compared to chemotherapy.
- TIVDAK demonstrated a 30% reduction in the risk of death
compared to chemotherapy (hazard ratio [HR]: 0.70 [95% CI:
0.54-0.89], two-sided p=0.0038)2. Median OS for patients treated
with TIVDAK was 11.5 months [95% CI: 9.8-14.9] versus chemotherapy
9.5 months [95% CI: 7.9-10.7].
- PFS and confirmed ORR were also significantly improved compared
to chemotherapy.
- The safety profile of TIVDAK was consistent with its known
safety profile as presented in the U.S. prescribing information,
and no new safety signals were observed.
Based on these encouraging results, Zai Lab intends to submit an
NDA for TIVDAK to China’s National Medical Products Administration
(NMPA) in the first quarter of 2025. The full China subpopulation
data will be presented at a future medical conference in 2025.
About innovaTV 301 Trial Design
The innovaTV 301 trial (NCT04697628) is a global, 1:1
randomized, open-label Phase 3 trial evaluating TIVDAK® (tisotumab
vedotin) versus investigator’s choice of single agent chemotherapy
(topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed)
with recurrent or metastatic cervical cancer who received
chemotherapy.
Patients with recurrent or metastatic cervical cancer with
squamous cell, adenocarcinoma, or adenosquamous histology, and
disease progression during or after treatment with chemotherapy
doublet +/- bevacizumab and an anti-PD-(L)1 agent (if eligible) are
included. The primary endpoint was overall survival. The main
secondary outcomes were progression-free survival and objective
response rate.
The study was conducted by Seagen, which was acquired by Pfizer
in December 2023, in collaboration with Genmab, European Network of
Gynaecological Oncological Trial Groups (ENGOT, study number ENGOT
cx-12) and the Gynecologic Oncology Group (GOG) Foundation (study
number GOG 3057), as well as other global gynecological oncology
cooperative groups.
For more information about the Phase 3 innovaTV 301 clinical
trial and other clinical trials with tisotumab vedotin, please
visit www.clinicaltrials.gov.
About Cervical Cancer in China
Cervical cancer remains one of the leading causes of cancer
death in women in China and globally. An estimated 150,000 new
cases of cervical cancer occur annually in China1. Current
treatment options are limited for patients with recurrent or
metastatic cervical cancer with disease progression on or after
systemic therapy. TIVDAK is well positioned to provide a new option
for previously treated advanced cervical cancer patients who
currently have limited treatment options and poor outcomes.
About TIVDAK® (tisotumab vedotin)
TIVDAK® (tisotumab vedotin) is an antibody-drug conjugate (ADC)
composed of Genmab’s human monoclonal antibody directed to tissue
factor (TF) and Pfizer’s ADC technology that utilizes a
protease-cleavable linker that covalently attaches the
microtubule-disrupting agent monomethyl auristatin E (MMAE) to the
antibody. Nonclinical data suggest that the anticancer activity of
tisotumab vedotin is due to the binding of the ADC to TF-expressing
cancer cells, followed by internalization of the ADC-TF complex,
and release of MMAE via proteolytic cleavage. MMAE disrupts the
microtubule network of actively dividing cells, leading to cell
cycle arrest and apoptotic cell death. In vitro, tisotumab vedotin
also mediates antibody-dependent cellular phagocytosis and
antibody-dependent cellular cytotoxicity.
TIVDAK received accelerated approval from the FDA in September
2021 and full approval in April 2024 for adult patients with
recurrent or metastatic cervical cancer with disease progression on
or after chemotherapy.
Please see full prescribing information, including BOXED WARNING
for TIVDAK here.
Zai Lab has an exclusive license from Seagen Inc., a company
later acquired by Pfizer, to develop and commercialize TIVDAK in
Greater China (mainland China, Hong Kong, Macau, and Taiwan,
collectively).
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, immunology, neuroscience and infectious disease. Our goal
is to leverage our competencies and resources to positively impact
human health 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 relating
to our future expectations, plans, and prospects, including,
without limitation, statements relating to our prospects and plans
for developing and commercializing TIVDAK in Greater China, the
potential benefits of TIVDAK, and the potential treatment of
cervical 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 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 decisions, (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 the SEC’s website at www.sec.gov.
Notes: 1 Bingfeng Han et al., "Cancer incidence and mortality in
China, 2022" Journal of the National Cancer Center, 2024. DOI:
10.1016/j.jncc.2024.01.006. 2 The threshold for statistical
significance is 0.0226 (2-sided).
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version on businesswire.com: https://www.businesswire.com/news/home/20250115437262/en/
Investor Relations: Christine Chiou / Lina Zhang +1 (917)
886-6929 / +86 136 8257 6943 christine.chiou1@zailaboratory.com /
lina.zhang@zailaboratory.com
Media: Shaun Maccoun / Xiaoyu Chen +1 (857) 270-8854 /
+86 185 0015 5011 shaun.maccoun@zailaboratory.com /
xiaoyu.chen@zailaboratory.com
Zai Lab (NASDAQ:ZLAB)
過去 株価チャート
から 12 2024 まで 1 2025
Zai Lab (NASDAQ:ZLAB)
過去 株価チャート
から 1 2024 まで 1 2025
