-- Objective response rate (ORR) of 74% across
all tested dose levels of ZL-1310 in patients with recurrent
extensive-stage small cell lung cancer (SCLC)
-- Favorable pharmacokinetics (PK) and safety
profile support continued evaluation of ZL-1310 as a single agent
and in combination for the treatment of extensive-stage SCLC in
recurrent and first-line therapy
-- Zai Lab to host conference call and webcast
to discuss data on October 24, 2024, at 8:30 a.m. ET, following
presentation of the data at ENA
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today presented data
from the ongoing global Phase 1a/1b study of ZL-1310, a potential
best-in-class next-generation antibody-drug conjugate (ADC), at the
EORTC-NCI-AACR (ENA) Symposium 2024 in Barcelona, Spain, as an oral
presentation during the plenary session. ZL-1310 is being tested in
patients with previously treated extensive-stage Small Cell Lung
Cancer (ES-SCLC) after at least one prior platinum-based
chemotherapy regimen.
Data shared in the ENA presentation from the ongoing Part 1a
monotherapy dose-escalation portion of the study included results
from 25 patients across four dose cohorts (0.8 mg/kg, 1.6mg/kg, 2.0
mg/kg, and 2.4 mg/kg). Nineteen patients had evaluable tumor
assessments.
Key efficacy results include (n=19):
- The ORR in patients with at least one post-treatment evaluation
was 74% (95%CI, 48.8, 90.9). ZL-1310 anti-tumor activity was
demonstrated across all dose levels.
- Responses were seen in patients with DLL3 H-scores from 5
(range: 5 to 260). No response was observed in a patient whose
tumor did not express DLL3.
- Across all cohorts, median length of follow up is 2.4 months
making duration of response not estimable. Of the 14 responders, 13
remain on treatment with the longest patient ongoing at 6.5+
months.
- Of the six response-evaluable patients with baseline brain
metastases, all achieved a partial response (PR).
- One patient who progressed after prior DLL3 bi-specific therapy
achieved PR at the first tumor assessment.
Key safety findings include (n=25):
- ZL-1310 was well tolerated across all dose levels with the
majority of treatment emergent adverse events (TEAE) being Grade 1
or 2. One dose-limiting toxicity (DLT) was observed at 2.4mg/kg
(Grade 4 transient neutropenia/thrombocytopenia). Grade ≥3
treatment-related adverse events occurred in five of the 25
patients (20%); neutropenia was the most common grade ≥3 event,
occurring in three of the 25 patients (12%). Serious
treatment-related adverse events occurred in two patients (8%);
three patients (12%) required dose reductions, and no patients
discontinued treatment due to TEAE.
All patients had progressed following standard platinum-based
chemotherapy, and 92% of patients progressed after immune
checkpoint inhibitors. Fifty-six percent had failed at least two
prior lines of therapy. Twenty-eight percent of patients had brain
metastases at baseline. At the time of the data cutoff, Oct. 10,
2024, 19 patients had at least one post-baseline tumor assessment
per RECIST v1.1. DLL3 expression H-scores were assessed in 16 out
of 19 patients.
“The preliminary results from the ongoing Phase 1 trial of
ZL-1310 suggest that this next-generation ADC therapy has the
potential to deliver anti-tumor responses in the majority of
patients with ES-SCLC, with good tolerability,” said Dr. Alex
Spira, a medical oncologist at Virginia Cancer Specialists and NEXT
Oncology. “This is particularly encouraging given the urgent need
for improved treatment options for these patients. These promising
data support continued evaluation of ZL-1310 as a monotherapy in
the dose-expansion phase of the ongoing Phase 1 clinical trial and
in combination.”
“The ZL-1310 clinical program demonstrates Zai Lab’s commitment
and ability to pursue novel modalities and validated cancer
targets, and to advance innovative global oncology programs,” said
Rafael G. Amado, M.D., President, Head of Global Research and
Development, Zai Lab. “Based on the encouraging preliminary
findings from our Phase 1 trial, we look forward to continuing
development of ZL-1310 and advancing this promising asset across
lines of therapy as part of our global oncology pipeline.”
Webcast and Conference Call
To access the webcast and conference call on October 24, 2024,
at 8:30 a.m. ET, please register at
https://register.vevent.com/register/BI6f8ba8dc42d04cd3afd7095cf7c83d40.
All participants must use the link provided above to complete
the online registration process in advance of the conference call.
Dial-in details will be in the confirmation email which the
participant will receive upon registering.
A replay will be available shortly after the call and can be
accessed by visiting the Company's website.
About Zai Lab
Zai Lab (NASDAQ: ZLAB; HKEX: 9688; “Zai Lab”) 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 ZL-1310
ZL-1310 is a novel ADC in Zai Lab’s growing, global oncology
pipeline that targets Delta-like ligand 3 (DLL3), an antigen that
is overexpressed in many neuroendocrine tumors, is typically
associated with poor clinical outcomes, and is a validated
therapeutic target for SCLC. ZL-1310 comprises a humanized
anti-DLL3 monoclonal antibody linked to a novel camptothecin
derivative (a topoisomerase 1 inhibitor) as its payload. The
compound was designed with a novel ADC technology platform called
TMALIN®, which leverages the tumor microenvironment to overcome
challenges associated with first-generation ADC therapies,
including off-target payload toxicity.
The ongoing Phase 1a/1b clinical trial is evaluating ZL-1310 as
monotherapy and in combination with atezolizumab, an immune
checkpoint inhibitor, for the treatment of extensive-stage
SCLC.
Zai Lab Forward-Looking Statements
This press release contains forward-looking statements relating
to our future expectations, plans, and prospects, for Zai Lab,
including, without limitation, statements relating to our prospects
and plans for developing and commercializing next generation ADCs,
including ZL-1310, the potential benefits of ZL-1310, and the
potential treatment of SCLC and neuroendocrine tumors. 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 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 (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 on the SEC’s website at www.sec.gov.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20241024949177/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 1 2025 まで 2 2025
Zai Lab (NASDAQ:ZLAB)
過去 株価チャート
から 2 2024 まで 2 2025
