PANOVA-3 met its primary endpoint with a
statistically significant improvement in overall survival for
patients with unresectable, locally advanced pancreatic
adenocarcinoma treated in the first-line with TTFields concomitant
with gemcitabine and nab-paclitaxel
Novocure plans to file for regulatory approval
in the U.S., EU, Japan and other key markets; Zai Lab plans to file
for regulatory approval in China
Full results from the PANOVA-3 trial will be
presented at an upcoming medical congress
Zai Lab Limited (Nasdaq: ZLAB; HKEX: 9688) and Novocure (NASDAQ:
NVCR) announced today that the pivotal, Phase 3 PANOVA-3 trial met
its primary endpoint, demonstrating a statistically significant
improvement in median overall survival (mOS) versus control.
PANOVA-3 evaluated the use of Tumor Treating Fields (TTFields)
therapy concomitantly with gemcitabine and nab-paclitaxel as a
first-line treatment for unresectable, locally advanced pancreatic
adenocarcinoma.
“As a researcher and clinician, I have experienced the
challenges of developing treatments in pancreatic cancer. It is
exciting to see the PANOVA-3 trial achieve the positive primary
endpoint of overall survival, a landmark outcome for this field,”
said Vincent Picozzi, M.D., medical oncologist and investigator in
the PANOVA-3 trial. “These data for Tumor Treating Fields are very
promising, especially in this difficult to treat patient
population.”
In the intent-to-treat population, patients treated with
TTFields therapy concomitant with gemcitabine and nab-paclitaxel
had an mOS of 16.20 months compared to 14.16 months in patients
treated with gemcitabine and nab-paclitaxel alone, a statistically
significant 2.0-month improvement (hazard ratio=0.819; P=0.039)
(N=571). The survival rate benefit for patients treated with
TTFields therapy increased over time with a 13% improvement in the
overall survival rate at 12 months and a 33% improvement in
survival rate at 24 months. TTFields therapy was well-tolerated,
and safety was consistent with prior clinical studies.
“PANOVA-3 is the first and only Phase 3 trial to demonstrate a
statistically significant benefit in overall survival specifically
in unresectable, locally advanced pancreatic cancer, and is
Novocure’s third positive Phase 3 clinical trial in the last two
years,” said Nicolas Leupin, M.D., PhD, Chief Medical Officer,
Novocure. “We are grateful to the patients and investigators for
their participation in the trial, and we look forward to sharing
the full data at an upcoming medical conference.”
“There are approximately 134,000 new cases of pancreatic cancer
diagnosed annually in China, and this cancer is one of the most
challenging to treat globally, with limited effective treatment
options and poor survival outcomes,” said Dr. Rafael Amado, M.D.,
President, Head of Global Research and Development at Zai Lab.
“Demonstrating a statistically significant and clinically
meaningful improvement in overall survival for patients with
unresectable, locally advanced pancreatic cancer is an important
achievement. We are pleased to have been able to contribute to the
PANOVA-3 study, and we look forward to working with Novocure to
bring this therapy to patients as soon as possible.”
Novocure plans to file for regulatory approval of TTFields in
unresectable, locally advanced pancreatic adenocarcinoma based on
PANOVA-3 and plans to submit the PANOVA-3 results for presentation
at an upcoming medical congress. Zai Lab plans to file for
regulatory approval in China.
About PANOVA-3
PANOVA-3 is a prospective, randomized open-label, controlled
Phase 3 clinical trial designed to test the efficacy and safety of
Tumor Treating Fields (TTFields) therapy used concomitantly with
gemcitabine and nab-paclitaxel, as a first-line treatment of
locally advanced pancreatic adenocarcinoma. Patients were
randomized to receive either TTFields therapy concomitant with
gemcitabine and nab-paclitaxel or gemcitabine and nab-paclitaxel
alone.
The primary endpoint is overall survival. Secondary endpoints
include progression free survival, local progression free survival,
objective response rate, one-year survival rate, quality of life,
pain-free survival, puncture-free survival, resectability rate, and
toxicity.
A total of 571 patients were enrolled in the study, randomized
1:1 and followed for a minimum of 18 months.
About Pancreatic Cancer in China
Pancreatic cancer is one of the most common and deadliest
cancers globally. In China, there were an estimated 134,374 new
cases in 2022, and it is now the eighth most common cancer type1.
The current median survival of patients with locally advanced,
unresectable pancreatic cancer is nine to twelve months, and the
five-year survival rate was 7.2%2, making it the malignancy with
the lowest survival rate in China.
1 Xia C, Dong X, Li H et al. Cancer statistics in China and
United States, 2022: profiles, trends, and determinants. Chin Med J
(Engl) 2022; 135: 584-590.
2 Hu JX, Zhao CF, Chen WB et al. Pancreatic cancer: A review of
epidemiology, trend, and risk factors. World J Gastroenterol 2021;
27: 4298-4321.
About Tumor Treating Fields
Tumor Treating Fields (TTFields) are electric fields that exert
physical forces to kill cancer cells via a variety of mechanisms.
TTFields do not significantly affect healthy cells because they
have different properties (including division rate, morphology, and
electrical properties) than cancer cells. These multiple, distinct
mechanisms work together to target and kill cancer cells. Due to
these multimechanistic actions, TTFields therapy can be added to
cancer treatment modalities in approved indications and
demonstrates enhanced effects across solid tumor types when used
with chemotherapy, radiotherapy, immune checkpoint inhibition, or
targeted therapies in preclinical models. TTFields therapy provides
clinical versatility that has the potential to help address
treatment challenges across a range of solid tumors.
To learn more about TTFields therapy and its multifaceted effect
on cancer cells, visit tumortreatingfields.com.
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. 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 in China and worldwide.
For additional information about Zai Lab, please visit
www.zailaboratory.com or follow us at
www.twitter.com/ZaiLab_Global.
About Novocure
Novocure is a global oncology company working to extend survival
in some of the most aggressive forms of cancer through the
development and commercialization of its innovative therapy, Tumor
Treating Fields. Novocure’s commercialized products are approved in
certain countries for the treatment of adult patients with
glioblastoma, non-small cell lung cancer, malignant pleural
mesothelioma and pleural mesothelioma. Novocure has several
additional ongoing or completed clinical trials exploring the use
of Tumor Treating Fields therapy in the treatment of glioblastoma,
non-small cell lung cancer and pancreatic cancer.
Novocure’s global headquarters is located in Root Switzerland,
with U.S. headquarters located in Portsmouth, New Hampshire and
research and development facilities located in Haifa, Israel. For
additional information about the company, please visit Novocure.com
and follow @Novocure on LinkedIn and X (Twitter).
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 of and plans
for developing and commercializing TTFields therapy, the potential
benefits of TTFields therapy, and the potential treatment of
pancreatic 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 initiatives, (3) the results of 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 (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 the SEC’s website at www.sec.gov.
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version on businesswire.com: https://www.businesswire.com/news/home/20241202363277/en/
For more information, please contact:
Zai Lab Investor Relations: Christine
Chiou / Lina Zhang +1 (917) 886-6929 / +86 136 8257 6943
christine.chiou1@zailaboratory.com / lina.zhang@zailaboratory.com
Zai Lab Media: Shaun Maccoun / Xiaoyu Chen +1
(415) 317-7255 / +86 185 0015 5011
shaun.maccoun@zailaboratory.com / xiaoyu.chen@zailaboratory.com
Novocure Investors: Ingrid Goldberg
investorinfo@novocure.com
Novocure Media: Catherine Falcetti media@novocure.com
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