Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) and Novocure (NASDAQ:
NVCR) today announced an update regarding its phase 3 pivotal LUNAR
trial of Tumor Treating Fields (TTFields) in stage 4 non-small cell
lung cancer (NSCLC) following platinum failure. Following a routine
review of the study by an independent data monitoring committee
(DMC), Novocure was informed that the pre-specified interim
analysis for the LUNAR trial would be accelerated given the length
of accrual and the number of events observed, to date. The interim
analysis included data from 210 patients accrued to the LUNAR trial
through February 2021. After review of the interim analysis report,
the DMC concluded that the LUNAR trial should continue with no
evidence of increased systemic toxicity.
The DMC also stated that it is likely unnecessary and possibly
unethical for patients randomized to the control arm to continue
accrual to 534 patients with 18 months follow-up. The DMC
recommended a reduced sample size of approximately 276 patients
with 12 months follow-up which it believes will provide sufficient
overall power for both primary and secondary endpoints. The DMC
recommended no other changes to the design of the trial. Novocure
remains blinded to all data.
The primary endpoint of the LUNAR trial is superior overall
survival when patients are treated with TTFields plus immune
checkpoint inhibitors or docetaxel versus immune checkpoint
inhibitors or docetaxel alone. The final analysis will also include
an analysis of overall survival in the immune checkpoint inhibitor
and docetaxel treatment subgroups.
Novocure has notified the U.S. Food and Drug Administration
(FDA) of the DMC recommendations and of its intent to submit an
Investigational Device Exemption (IDE) supplement incorporating the
recommended protocol adjustments.
“We are very pleased with the DMC recommendations, which we
believe support the potential for TTFields to make a significant
difference in treatment outcomes for patients with non-small cell
lung cancer, whether used together with immune checkpoint
inhibitors or docetaxel,” said William Doyle, Novocure’s Executive
Chairman. “The accelerated interim analysis with an encouraging
outcome adds to the accumulating evidence of Tumor Treating Fields’
broad potential across a range of hard-to-treat cancers.”
“Combination therapy is a cornerstone of cancer care, and we
believe using TTFields together with other cancer treatments,
including immunotherapies, may lead to better outcomes for some
patients,” continued Mr. Doyle. “We are very encouraged that,
consistent with our expectations, the DMC concluded that TTFields
exhibited no systemic toxicity. We will continue to develop
TTFields as a limited toxicity backbone therapy upon which other
standard-of-care and emerging cancer treatments can be added.”
Lung cancer is the most common cause of cancer-related death
worldwide, and NSCLC accounts for approximately 85% of all lung
cancers. It is estimated that approximately 193,000 patients are
diagnosed with NSCLC each year in the U.S. and approximately 46,000
patients receive second-line treatment for stage 4 NSCLC each year
in the U.S. Physicians use different combinations of surgery,
radiation and pharmacological therapies to treat NSCLC, depending
on the stage of the disease. TTFields is intended principally for
use together with other standard-of-care treatments, and LUNAR was
designed to generate data that contemplates multiple outcomes, all
of which Novocure believes will be clinically meaningful.
“The completion of the LUNAR interim analysis is an important
milestone for Novocure,” said Asaf Danziger, Novocure’s CEO. “We
are grateful to the DMC members for their diligence, guidance and
support, and are looking forward to working closely with the FDA on
amendments to the protocol given the DMC’s recommendations. Pending
regulatory approval, the recommended protocol adjustments could
accelerate trial completion by more than a year. We look forward to
sharing final data from the LUNAR trial as quickly as
possible.”
About NSCLC in ChinaLung cancer consists of
NSCLC in approximately 85% of cases and small cell lung cancer
(SCLC) in approximately 15% of cases. Lung cancer has the highest
total incidence of any cancer in China. According to the World
Health Organization, the incidence of lung cancer in China in 2020
was 815,563 cases, with 714,699 deaths. In China, the five-year
survival rate of lung cancer is estimated to be about 20%.
About LUNARLUNAR is a phase 3 pivotal trial
testing the effectiveness of TTFields in combination with immune
checkpoint inhibitors or docetaxel versus immune checkpoint
inhibitors or docetaxel alone for patients with stage 4 NSCLC who
progressed during or after platinum-based therapy. It is estimated
that approximately 46,000 patients receive second-line treatment
for stage 4 NSCLC each year in the U.S. The primary endpoint is
superior overall survival of patients treated with TTFields plus
immune checkpoint inhibitors or docetaxel versus immune checkpoint
inhibitors or docetaxel alone. TTFields is intended principally for
use in combination with other standard-of-care treatments, and
LUNAR was designed to generate data that contemplates multiple
outcomes, all of which Novocure believes will be clinically
meaningful.
About Tumor Treating FieldsTumor Treating
Fields, or TTFields, are electric fields that disrupt cancer cell
division.
When cancer develops, rapid and uncontrolled division of
unhealthy cells occurs. Electrically charged proteins within the
cell are critical for cell division, making the rapidly dividing
cancer cells vulnerable to electrical interference. All cells are
surrounded by a bilipid membrane, which separates the interior of
the cell, or cytoplasm, from the space around it. This membrane
prevents low frequency electric fields from entering the cell.
TTFields, however, have a unique frequency range, between 100 to
500 kHz, enabling the electric fields to penetrate the cancer cell
membrane. As healthy cells differ from cancer cells in their
division rate, geometry and electric properties, the frequency of
TTFields can be tuned to specifically affect the cancer cells while
leaving healthy cells mostly unaffected.
Whether cells are healthy or cancerous, cell division, or
mitosis, is the same. When mitosis starts, charged proteins within
the cell, or microtubules, form the mitotic spindle. The spindle is
built on electric interaction between its building blocks. During
division, the mitotic spindle segregates the chromosomes, pulling
them in opposite directions. As the daughter cells begin to form,
electrically polarized molecules migrate towards the midline to
make up the mitotic cleavage furrow. The furrow contracts and the
two daughter cells separate. TTFields can interfere with these
conditions. When TTFields are present in a dividing cancer cell,
they cause the electrically charged proteins to align with the
directional forces applied by the field, thus preventing the
mitotic spindle from forming. Electrical forces also interrupt the
migration of key proteins to the cell midline, disrupting the
formation of the mitotic cleavage furrow. Interfering with these
key processes disrupts mitosis and can lead to cell death.
TTFields is intended principally for use together with other
standard-of-care cancer treatments. There is a growing body of
evidence that supports TTFields' broad applicability with certain
other cancer therapies, including radiation therapy, certain
chemotherapies and certain immunotherapies. In clinical research
and commercial experience to date, TTFields has exhibited no
systemic toxicity, with mild to moderate skin irritation being the
most common side effect.
Fundamental scientific research extends across two decades and,
in all preclinical research to date, TTFields has demonstrated a
consistent anti-mitotic effect. The TTFields global development
program includes a broad range of clinical trials across all
phases, included four phase 3 pivotal trials in a variety of tumor
types. To date, more than 18,000 patients have been treated with
TTFields.
Use of Tumor Treating Fields for the treatment of NSCLC is
investigational only.
About Zai LabZai Lab (NASDAQ: ZLAB; HKEX: 9688)
is an innovative commercial-stage biopharmaceutical company focused
on bringing transformative medicines for cancer and infectious and
autoimmune diseases to patients in China and around the world. We
aim to address significant unmet medical needs in large,
fast-growing segments of the pharmaceutical market. Our experienced
team has secured partnerships with leading global biopharmaceutical
companies to generate a broad pipeline of potentially innovative,
marketed products and product candidates. We have also built an
in-house team with strong drug discovery and translational research
capabilities and are establishing a pipeline of proprietary drug
candidates with global rights. Our vision is to become a leading
global biopharmaceutical company, discovering, developing,
manufacturing and commercializing our portfolio in order to
positively impact human health worldwide.
For additional information about the company, please visit
www.zailaboratory.com or follow us at
www.twitter.com/ZaiLab_Global.
About NovocureNovocure 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, TTFields. TTFields are electric fields that
disrupt cancer cell division. Novocure’s commercialized products
are approved for the treatment of adult patients with glioblastoma
and malignant pleural mesothelioma. Novocure has ongoing clinical
trials investigating TTFields in brain metastases, gastric cancer,
glioblastoma, liver cancer, non-small cell lung cancer, pancreatic
cancer and ovarian cancer.
Headquartered in Jersey, Novocure has U.S. operations in
Portsmouth, New Hampshire, Malvern, Pennsylvania and New York City.
Additionally, the company has offices in Germany, Switzerland,
Japan and Israel. For additional information about the company,
please visit www.novocure.com or follow us at
www.twitter.com/novocure.
Zai Lab Forward-Looking
StatementsThis press release contains statements about
future expectations, plans and prospects for Zai Lab, including,
without limitation, statements regarding the prospects and plans
for developing and commercializing Tumor Treating Fields in Greater
China and other statements containing words such as “anticipates”,
“believes”, “expects”, “plans”, “can be” 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 Zai Lab’s
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) Zai Lab’s ability to successfully commercialize and generate
revenue from its approved products; (2) Zai Lab’s ability to
finance its operations and business initiatives and obtain funding
for such activities, (3) Zai Lab’s results of clinical and
pre-clinical development of its product candidates, (4) the content
and timing of decisions made by the relevant regulatory authorities
regarding regulatory approvals of Zai Lab’s product candidates, (5)
the effects of the novel coronavirus (COVID-19) pandemic on general
economic, regulatory and political conditions and (6) other factors
discussed in Zai Lab’s Annual Report on Form 10-K for the fiscal
year ended December 31, 2020, filed on March 1, 2021, and its other
filings with the Securities and Exchange Commission. Zai Lab
anticipates that subsequent events and developments will cause Zai
Lab’s expectations and assumptions to change and undertakes 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 Zai Lab’s views as of any
date subsequent to the date of this press release.
Novocure Forward-Looking
StatementsIn addition to historical facts or statements of
current condition, this press release may contain forward-looking
statements. Forward-looking statements provide Novocure’s current
expectations or forecasts of future events. These may include
statements regarding LUNAR progress and timelines, interpretation
of the LUNAR interim analysis, anticipated scientific progress on
its research programs, clinical trial progress, development of
potential products, interpretation of clinical results, prospects
for regulatory approval, manufacturing development and
capabilities, market prospects for its products, coverage,
collections from third-party payers and other statements regarding
matters that are not historical facts. You may identify some of
these forward-looking statements by the use of words in the
statements such as “anticipate,” “estimate,” “expect,” “project,”
“intend,” “plan,” “believe” or other words and terms of similar
meaning. Novocure’s performance and financial results could differ
materially from those reflected in these forward-looking statements
due to general financial, economic, regulatory and political
conditions as well as issues arising from the COVID-19 pandemic and
other more specific risks and uncertainties facing Novocure such as
those set forth in its Annual Report on Form 10-K filed on February
25, 2021, with the U.S. Securities and Exchange Commission. Given
these risks and uncertainties, any or all of these forward-looking
statements may prove to be incorrect. Therefore, you should not
rely on any such factors or forward-looking statements.
Furthermore, Novocure does not intend to update publicly any
forward-looking statement, except as required by law. Any
forward-looking statements herein speak only as of the date hereof.
The Private Securities Litigation Reform Act of 1995 permits this
discussion.
ZAI LAB CONTACTS:Zai LabBilly
Cho, CFO+86 137 6151 2501 billy.cho@zailaboratory.com
Media: Ryo Imai / Robert Flamm, Ph.D.Burns McClellan, on behalf
of Zai Lab212-213-0006 ext. 315 / 364rimai@burnsmc.com /
rflamm@burnsmc.com
Investors: Mike ZanoniEndurance Advisors, on behalf of Zai
Lab610-442-8570mzanoni@enduranceadvisors.com
Media and Investor Contact:Ashley
Cordova(212)767-7558media@novocure.cominvestorinfo@novocure.com
Zai Lab Limited
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