The METIS trial demonstrated 21.9 months median
time to intracranial progression for patients treated with Tumor
Treating Fields and supportive care compared to 11.3 months for
patients treated with supportive care alone
Zai Lab Limited (Nasdaq: ZLAB; HKEX: 9688) partner Novocure
(NASDAQ: NVCR) today announced the phase 3 METIS clinical trial met
its primary endpoint, demonstrating a statistically significant
improvement in time to intracranial progression for adult patients
treated with Tumor Treating Fields (TTFields) therapy and
supportive care compared to supportive care alone in the treatment
of patients with 1-10 brain metastases from non-small cell lung
cancer (NSCLC) following stereotactic radiosurgery (SRS). Patients
treated with TTFields therapy and supportive care exhibited a
median time to intracranial progression of 21.9 months compared to
11.3 months in patients treated with supportive care alone for
brain metastasis (n=298; hazard ratio=0.67; P=0.016). Median
TTFields therapy treatment duration was 16 weeks and median usage
was 67%. Consistent with previous studies, TTFields therapy was
well-tolerated with sustained quality of life and neurocognitive
function. Baseline characteristics were well balanced between
arms.
Preliminary analyses of key secondary endpoints (time to
neurocognitive failure, overall survival, and radiological response
rate) did not demonstrate statistical significance. Certain
secondary endpoints showed positive trends in favor of treatment
with TTFields therapy, including time to distant progression and
quality of life. Full analysis of secondary endpoints is
ongoing.
Novocure intends to submit these data to regulatory authorities.
Novocure also intends to publish these findings in a peer-reviewed
scientific journal and share them at an upcoming scientific
congress.
Zai Lab contributed to the METIS trial and achieved treatment of
the first patient in Greater China in May 2021.
About METIS
METIS [NCT02831959] is a phase 3 trial of stereotactic
radiosurgery with or without TTFields therapy for patients with
1-10 brain metastases from NSCLC. 298 adult patients were enrolled
in the trial and randomized to receive either TTFields therapy with
supportive care or supportive care alone following SRS. Supportive
care consisted of, but was not limited to, treatment with steroids,
anti-epileptic drugs, anticoagulants, pain control or nausea
control medications. Patients in both arms of the study were
eligible to receive systemic therapy for their NSCLC at the
discretion of their treating physician. Patients with known tumor
mutations for which targeted agents are available were excluded
from the trial.
The primary endpoint of the METIS trial is time to first
intracranial progression, as measured from the date of first SRS
treatment to intracranial progression or neurological death (per
RANO-BM criteria), whichever occurs first. Time to intracranial
progression was calculated according to the cumulative incident
function. Patient scans were evaluated by a blinded, independent
radiologic review committee. Secondary endpoints include, but are
not limited to, time to distant progression, time to neurocognitive
failure, overall survival, time to second intracranial progression,
quality of life and adverse events. Key secondary endpoints (time
to neurocognitive failure, overall survival, and radiological
response rate) were planned to be used in labeling claims, if
successful. Patients were stratified by the number of brain
metastases (1-4 or 5-10 metastases), prior systemic therapy, and
tumor histology. Patients were allowed to crossover to the
experimental TTFields therapy arm following confirmation of second
intracranial progression.
About Brain Metastases from NSCLC in China
Brain metastases are secondary tumors formed when cancer cells
break away from the primary tumor and travel through the blood or
lymph system to form new tumors (or metastases) in the brain. Brain
metastases are a negative prognostic factor in NSCLC and adversely
impact neurocognitive function and quality of life.
Each year in China, approximately 740,000 patients are newly
diagnosed with NSCLC. Approximately 20%–65% of lung cancer patients
develop brain metastases at some point during their illness.1 Among
patients who received chemotherapy, the survival of patients with
brain metastases at diagnosis was still poor, which is about six
months.2
Treatment options for patients with brain metastases from NSCLC
are limited to neurosurgery, SRS, whole brain radiation therapy, or
combinations of these options. However, given the neurotoxicity and
significant decline in cognitive functioning, whole brain radiation
therapy (WBRT) is an unfavorable treatment option. New therapeutic
options are needed for greater intracranial control while
minimizing the risk of neurocognitive adverse events.
1 China guidelines for the treatment of brain metastases from
lung cancer (2021 edition). Chinese Journal of Oncology, 2021,
43(3): 269-281. DOI: 10.3760/cma.j.cn112152-20210104-00009. 2 Ali,
A., Goffin, J. R., Arnold, A., & Ellis, P. M. (2013). Survival
of patients with non-small-cell lung cancer after a diagnosis of
brain metastases. Current oncology (Toronto, Ont.), 20(4),
e300–e306. https://doi.org/10.3747/co.20.1481.
About Tumor Treating Fields Therapy
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. The multiple, distinct
mechanisms of TTFields therapy work together to selectively target
and kill cancer cells. Due to its 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 PARP inhibition 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 Tumor Treating Fields therapy and
its multifaceted effect on cancer cells, visit
tumortreatingfields.com.
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 forward-looking statements relating
to the future expectations, plans, and prospects, for Zai Lab,
including, without limitation, statements relating to Zai Lab’s
prospects and plans for developing and commercializing TTFields,
the potential benefits of TTFields, and the potential treatment for
patients with brain metastases from NSCLC. 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 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 the approved
products, (2) Zai Lab’s ability to obtain funding for the
operations and business initiatives, (3) the results of Zai Lab’s
clinical and pre-clinical development of the product candidates,
(4) the content and timing of decisions made by the relevant
regulatory authorities regarding regulatory approvals of the
product candidates, (5) risks related to doing business in China,
and (6) other factors identified in Zai Lab’s most recent annual
and quarterly reports and in other reports Zai Lab has filed with
the U.S. Securities and Exchange Commission (SEC). Zai Lab
anticipates that subsequent events and developments will cause the
expectations and assumptions to change, and Zai Lab 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.
Zai Lab’s SEC filings can be found on the website at
www.zailaboratory.com and on the SEC’s website at www.sec.gov.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240327008557/en/
For more information, please contact: 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 (415) 317-7255 / +86 185 0015 5011
shaun.maccoun@zailaboratory.com / xiaoyu.chen@zailaboratory.com
Zai Lab (NASDAQ:ZLAB)
Historical Stock Chart
From Aug 2024 to Sep 2024
Zai Lab (NASDAQ:ZLAB)
Historical Stock Chart
From Sep 2023 to Sep 2024