Zai Lab Partner Bristol Myers Squibb
Announces Pivotal KRYSTAL-12 Confirmatory Trial Evaluating KRAZATI
(adagrasib) Meets Primary Endpoint of Progression-Free Survival for
Patients with Pretreated KRASG12C-Mutated Locally Advanced or
Metastatic Non-Small Cell Lung Cancer
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688)
partner Bristol Myers Squibb (NYSE: BMY) announced the pivotal
Phase 3 KRYSTAL-12 study, evaluating KRAZATI® (adagrasib) as a
monotherapy in patients with pretreated locally advanced or
metastatic non-small cell lung cancer (NSCLC) harboring a KRASG12C
mutation, met the primary endpoint of progression-free survival
(PFS) and the key secondary endpoint of overall response rate (ORR)
as assessed by Blinded Independent Central Review (BICR) at final
analysis for these endpoints. The study remains ongoing to assess
the additional key secondary endpoint of overall survival. Results
of the confirmatory trial showed that KRAZATI demonstrated a
statistically significant and clinically meaningful benefit in PFS
and ORR compared to standard-of-care chemotherapy as a second-line
or later treatment for these patients. KRAZATI had no new safety
signals and the safety data was consistent with the known safety
profile.
“We are delighted to see these data underscoring the potential
of adagrasib as a therapy for patients with KRASG12C mutated NSCLC
in second or later line treatment,” said Rafael G. Amado, M.D.,
President, Head of Global Oncology Research and Development, Zai
Lab. “Lung cancer is the most common cancer in China, and adagrasib
is one of several important products in Zai Lab’s growing lung
cancer pipeline. We are proud to have contributed to the KRYSTAL-12
study and are looking forward to bringing adagrasib to patients in
need in China."
Bristol Myers Squibb will complete a full evaluation of the
available data and will share the results with the scientific
community at an upcoming medical conference as well as discuss the
results with health authorities.
Zai Lab expects to submit the New Drug Application (NDA) for
adagrasib to the National Medical Products Association (NMPA) for
KRASG12C mutated NSCLC in second or later line treatment in China
this year.
In addition to KRASG12C-mutated NSCLC, KRAZATI and KRAZATI-based
combinations have shown encouraging meaningful benefit in Phase 2
clinical trials across several tumors, including advanced
colorectal cancer, pancreatic cancer and other solid tumors. In
February, the U.S. FDA accepted for priority review the
supplemental new drug application (sNDA) for KRAZATI in combination
with cetuximab for the treatment of patients with previously
treated KRASG12C-mutated locally advanced or metastatic colorectal
cancer (CRC). The FDA assigned a Prescription Drug User Fee Act
(PDUFA) goal date of June 21, 2024.
Zai Lab thanks the patients and investigators involved in the
KRYSTAL-12 clinical trial.
About NSCLC 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. Lung cancer consists of NSCLC
in approximately 85% of cases and small cell lung cancer (SCLC) in
approximately 15% of cases. KRASG12C is the most common KRAS
mutation in NSCLC. The mutation is a biomarker of poor prognosis in
Chinese patients with NSCLC.
ABOUT KRAZATI® (adagrasib) KRAZATI (adagrasib) is
highly selective and potent oral small-molecule inhibitor of
KRASG12C that is optimized to sustain target inhibition, an
attribute that could be important to treat KRASG12C-mutated
cancers, as the KRAS protein regenerates every 24-48 hours. In
China, it is estimated that there are around 42,000 patients each
year with KRASG12C-mutated NSCLC and colorectal cancer indications
alone.
In 2022, KRAZATI was granted accelerated approval for treatment
of adult patients with KRASG12C-mutated locally advanced or
metastatic NSCLC, as determined by an FDA-approved test, who have
received at least one prior systemic therapy. This indication is
approved under accelerated approval based on objective response
rate (ORR) and duration of response (DOR). Continued approval for
this indication may be contingent upon verification and description
of a clinical benefit in a confirmatory trial(s).
In 2023, Medicines and Healthcare products Regulatory Agency
(MHRA) granted conditional marketing authorization for KRAZATI as a
targeted treatment option for adult patients with KRASG12C-mutated
advanced non-small cell lung cancer and disease progression after
at least one prior systemic therapy followed by the European
Commission (EC) in 2024.
KRAZATI continues to be evaluated as monotherapy and in
combination with other anti-cancer therapies in patients with
advanced KRASG12C-mutated solid tumors, including non-small cell
lung cancer and colorectal cancer.
In 2022, the FDA granted breakthrough therapy designation for
KRAZATI in combination with cetuximab in patients with
KRASG12C-mutated advanced colorectal cancer whose cancer has
progressed following prior treatment with chemotherapy and an
anti-VEGF therapy.
For U.S. Prescribing Information, visit KRAZATI.
About KRYSTAL-12 KRYSTAL-12 is an open-label,
multicenter, randomized Phase 3 study evaluating KRAZATI compared
to standard-of-care chemotherapy alone, in patients with
KRASG12C-mutated non-small cell lung cancer. The primary endpoint
of the study is PFS as assessed by BICR. Secondary endpoints
included overall survival (OS), overall response rate (ORR),
duration of response (DOR), and safety.
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 future expectations, plans, and prospects, including, without
limitation, statements relating to the potential benefits, safety,
and efficacy of adagrasib; the treatment of lung cancer; and
clinical trial data, data readouts, and presentations. These
forward-looking statements include, without limitation, statements
containing 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 nor are they 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 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20240401347225/en/
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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