- Initial data from the ongoing Phase 2 trial showed a
12-month overall survival (OS) rate of 69% and median overall
survival (mOS) of 17.5 months in patients with previously treated
PD-L1-positive mNSCLC treated with combination of acasunlimab with
pembrolizumab every six weeks
- Data from this ongoing Phase 2 study to inform the planned
pivotal Phase 3 trial, which is expected to start before the end of
2024
Genmab A/S (Nasdaq: GMAB) and BioNTech SE
(Nasdaq: BNTX) today announced initial data from the Phase 2
GCT1046-04 trial (NCT05117242) evaluating acasunlimab
(DuoBody-PD-L1x4-1BB), an investigational bispecific antibody also
known as GEN1046/BNT311, as monotherapy and in combination with
pembrolizumab in patients with PDL(1)-positive mNSCLC who had
disease progression following one or more prior lines of
anti-PD(L)1 containing treatment. The results showed a 12-month
overall survival (OS) rate of 69%, a median overall survival (mOS)
of 17.5 months, and a 30% overall response rate (ORR); (confirmed
ORR 17%) at time of data cut-off in patients treated with the
combination of acasunlimab and pembrolizumab every six weeks. The
findings were presented at the 2024 American Society of Clinical
Oncology (ASCO) Annual Meeting, being held in Chicago, IL and
virtually, May 31-June 4, 2024.
The Phase 2 study randomized a total of 113 patients in three
arms, evaluating acasunlimab alone (Arm A) and in combination with
pembrolizumab (Arms B and C). The objective response analysis was
conducted for 62 centrally confirmed PD-L1-positive
efficacy-evaluable patients. The overall survival was evaluated in
all centrally confirmed PD-L1-positive patients (n=80). Arm A
showed a median overall survival rate (mOS) of 5.5 month, 50%
disease control rate (DCR) and 31% ORR (confirmed ORR 13%) in
patients being treated with acasunlimab alone (Arm A), an 8.6 month
mOS, 59% DCR and 21% ORR (confirmed ORR 18%) with treatment of
acasunlimab in combination with pembrolizumab every three weeks
(Arm B) and a 17.5 mOS, 75% DCR and 30% ORR (confirmed ORR 17%)
when the combination was administered every six weeks (Arm C).
Anti-tumor activity was observed in patients with tumor proportion
score (TPS) of 1–49% and ≥50%, in patients with <6 months and ≥6
months of previous immune checkpoint inhibitor (CPI) treatment, and
in patients with squamous and non-squamous histology.
Adverse events were consistent with the safety profiles of the
individual drugs and treatment related adverse events (TRAEs) were
primarily grade 1 and 2. The most common TRAEs (all grades) in Arm
A were asthenia (22.7%), diarrhea (18.2%), nausea (18.2%), anemia
(13.6%) and liver-related events (13.6%). In combination arms (Arms
B and C) the most common TRAEs were liver-related events (28.6%,
18.4%), fatigue (21.4%, 8.2%), asthenia (12%, 12.2%), and diarrhea
(12%, 10.2%). Overall, a lower incidence of grade ≥3 TRAEs,
treatment-related liver-related events, and lower discontinuation
rates were observed with the combination therapy administered every
six weeks. Transaminase elevations were generally asymptomatic and
manageable with steroids and/or treatment delay and resolved more
rapidly in patients treated with the combination therapy
administered every six weeks.
“We are encouraged by the findings of this ongoing Phase 2
study. The initial results of acasunlimab in combination with
pembrolizumab administered every 6 weeks suggest a potential
meaningful impact on patients with metastatic non-small cell lung
cancer,” said Judith Klimovsky, Executive Vice President &
Chief Development Officer, Genmab. “We will continue to evaluate
these data to inform further development of acasunlimab including a
planned Phase 3 trial as we remain committed to investigate
acasunlimab as a potential treatment option.”
“Most patients with mNSCLC have limited treatment options
following progression on first-line checkpoint inhibitor therapy.
For these patients, chemotherapy remains the main treatment despite
limited efficacy and considerable toxicity,” said Prof. Özlem
Türeci, M.D., Chief Medical Officer and Co-Founder at BioNTech.
“The data of our Phase 2 trial show that the combination of
acasunlimab with PDL1-blockade may be a suitable approach in this
heavily pre-treated patient population.”
About the GCT1046-04 Clinical Trial
The GCT1046-04 trial (NCT05117242) is a randomized, open-label
trial evaluating the safety and efficacy of acasunlimab in patients
with relapsed/refractory metastatic non-small cell lung cancer
(mNSCLC) after treatment with standard of care therapy containing
immune checkpoint inhibitor therapy. Patients with stage IV NSCLC
with at least one prior line of systemic therapy containing an
anti-PD-1/PD-L1 and who have a tumor PD-L1 expression in ≥1% of
tumor cells are included in the study. The primary endpoint of the
trial is overall response rate (ORR). Key secondary endpoints
include overall survival (OS), progression free survival (PFS),
time to response (TTR), duration of response (DOR), and safety.
More information on this trial be found at clinicaltrials.gov.
About Non-small Cell Lung Cancer (NSCLC)
Non-small cell lung cancer (NSCLC) is the most common type of
lung cancer, accounting for about 85% of all reported cases. NSCLC
starts in the cells that line the airways and can grow into nearby
tissues or spread to other parts of the body. NSCLC is often
diagnosed at an advanced stage, when it is hard to treat and has a
poor prognosis. The treatment of NSCLC depends on the stage,
subtype, and biomarker status of the disease, and may include
surgery, radiation therapy, chemotherapy, targeted therapy,
immunotherapy, or a combination of these modalities. The survival
rate of NSCLC varies depending on the stage at
diagnosis.i,ii,iii
About Acasunlimab (GEN1046/BNT311)
Acasunlimab (GEN1046/BNT311) is an investigational PD-L1x4-1BB
bispecific antibody fusing Genmab's proprietary DuoBody® technology
platform and BioNTech’s proprietary immunomodulatory antibodies.
Acasunlimab is designed to elicit an antitumor response via
conditional activation of 4-1BB on T cells and natural killer (NK)
cells, which is strictly dependent on simultaneous binding of the
PD-L1 arm. Acasunlimab is being developed in collaboration with
BioNTech SE under a license and collaboration agreement. The
candidate is currently being investigated in three clinical trials:
(1) a Phase 1/2 safety and PK trial in patients with multiple solid
tumors, (2) a Phase 1 dose escalation trial in patients with
advanced solid tumors in Japan, and (3) a randomized Phase 2 safety
and efficacy trial with acasunlimab as a monotherapy and in
combination with pembrolizumab in patients with NSCLC who have
failed previous standard of care treatments with immune checkpoint
inhibitors. Please visit www.clinicaltrials.gov for more
information.
About Genmab
Genmab is an international biotechnology company with a core
purpose of guiding its unstoppable team to strive toward improving
the lives of patients with innovative and differentiated antibody
therapeutics. For 25 years, its passionate, innovative and
collaborative team has invented next-generation antibody technology
platforms and leveraged translational, quantitative and data
sciences, resulting in a proprietary pipeline including bispecific
T-cell engagers, antibody-drug conjugates, next-generation immune
checkpoint modulators and effector function-enhanced antibodies. By
2030, Genmab’s vision is to transform the lives of people with
cancer and other serious diseases with knock-your-socks-off (KYSO®)
antibody medicines.
Established in 1999, Genmab is headquartered in Copenhagen,
Denmark, with international presence across North America, Europe
and Asia Pacific. For more information, please visit Genmab.com and
follow us on LinkedIn and X.
Genmab Forward-Looking Statements
This Media Release contains forward looking statements. The
words “believe,” “expect,” “anticipate,” “intend” and “plan” and
similar expressions identify forward looking statements. Actual
results or performance may differ materially from any future
results or performance expressed or implied by such statements. The
important factors that could cause our actual results or
performance to differ materially include, among others, risks
associated with pre-clinical and clinical development of products,
uncertainties related to the outcome and conduct of clinical trials
including unforeseen safety issues, uncertainties related to
product manufacturing, the lack of market acceptance of our
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Genmab’s most recent Annual Report on Form 20-F and other filings
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available at www.sec.gov. Genmab does not undertake any obligation
to update or revise forward looking statements in this Media
Release nor to confirm such statements to reflect subsequent events
or circumstances after the date made or in relation to actual
results, unless required by law.
Genmab A/S and/or its subsidiaries own the following trademarks:
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About BioNTech
Biopharmaceutical New Technologies (BioNTech) is a global next
generation immunotherapy company pioneering novel therapies for
cancer and other serious diseases. BioNTech exploits a wide array
of computational discovery and therapeutic drug platforms for the
rapid development of novel biopharmaceuticals. Its broad portfolio
of oncology product candidates includes individualized and
off-the-shelf mRNA-based therapies, innovative chimeric antigen
receptor (CAR) T cells, several protein-based therapeutics,
including bispecific immune checkpoint modulators, targeted cancer
antibodies and antibody-drug conjugate (ADC) therapeutics, as well
as small molecules. Based on its deep expertise in mRNA vaccine
development and in-house manufacturing capabilities, BioNTech and
its collaborators are developing multiple mRNA vaccine candidates
for a range of infectious diseases alongside its diverse oncology
pipeline. BioNTech has established a broad set of relationships
with multiple global and specialized pharmaceutical collaborators,
including Biotheus, DualityBio, Fosun Pharma, Genentech, a member
of the Roche Group, Genevant, Genmab, MediLink, OncoC4, Pfizer and
Regeneron.
For more information, please visit www.biontech.com.
BioNTech Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, as amended, including, but not be limited to, statements
concerning: the collaboration between BioNTech and Genmab to
jointly clinical develop antibody candidates including
GEN1046/BNT311 (acasunlimab); the timing of a pivotal Phase 3 trial
with GEN1046/BNT311 as well as any subsequent data readouts; the
registrational potential of any trial we may initiate for
GEN1046/BNT311; BioNTech’s current and future preclinical studies
and clinical trials in oncology, including GEN1046/BNT311 in
patients with mNSCLC; the nature and characterization of and timing
for release of clinical data across BioNTech’s platforms, which is
subject to peer review, regulatory review and market
interpretation; the planned next steps in BioNTech’s pipeline
programs, including, but not limited to, statements regarding
timing or plans for initiation or enrollment of clinical trials, or
submission for and receipt of product approvals and potential
commercialization with respect to BioNTech’s product candidates;
the ability of BioNTech’s mRNA technology to demonstrate clinical
efficacy outside of BioNTech’s infectious disease platform; and the
potential safety and efficacy of BioNTech’s product candidates. In
some cases, forward-looking statements can be identified by
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“plans,” “aims,” “anticipates,” “believes,” “estimates,”
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or other comparable terminology, although not all forward-looking
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beliefs of future events, and are neither promises nor guarantees.
You should not place undue reliance on these forward-looking
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uncertainties, and other factors, many of which are beyond
BioNTech’s control and which could cause actual results to differ
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but are not limited to: the uncertainties inherent in research and
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endpoints, commencement and/or completion dates for clinical
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and/or launch dates, as well as risks associated with preclinical
and clinical data, including the data discussed in this release,
and including the possibility of unfavorable new preclinical,
clinical or safety data and further analyses of existing
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which is subject to ongoing peer review, regulatory review and
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results in future clinical trials; the timing of and BioNTech’s
ability to obtain and maintain regulatory approval for its product
candidates; discussions with regulatory agencies regarding timing
and requirements for additional clinical trials; BioNTech’s and its
counterparties’ ability to manage and source necessary energy
resources; BioNTech’s ability to identify research opportunities
and discover and develop investigational medicines; the ability and
willingness of BioNTech’s third-party collaborators to continue
research and development activities relating to BioNTech’s
development candidates and investigational medicines; unforeseen
safety issues and potential claims that are alleged to arise from
the use of products and product candidates developed or
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to commercialize and market, if approved, its product candidates;
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regulatory developments in the United States and other countries;
BioNTech’s ability to effectively scale its production capabilities
and manufacture its products and product candidates; risks relating
to the global financial system and markets; and other factors not
known to BioNTech at this time.
You should review the risks and uncertainties described under
the heading “Risk Factors” in BioNTech's Report on Form 6-K for the
period ended March 31, 2024 and in subsequent filings made by
BioNTech with the SEC, which are available on the SEC’s website at
www.sec.gov. These forward-looking statements speak only as of the
date hereof. Except as required by law, BioNTech disclaims any
intention or responsibility for updating or revising any
forward-looking statements contained in this press release in the
event of new information, future developments or otherwise.
i American Cancer Society. What is Non-Small Cell Lung Cancer?
https://www.cancer.org/cancer/types/lung-cancer.html. Accessed May
14, 2024.
ii Mayo Clinic. Non-Small Cell Lung Cancer.
https://www.mayoclinic.org/diseases-conditions/lung-cancer/symptoms-causes/syc-20374620.
Accessed May 14, 2024.
iii CancerNet. Lung Cancer – Non-Small Cell: Introduction.
https://www.cancer.net/cancer-types/lung-cancer-non-small-cell/introduction.
Accessed May 14, 2024.
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version on businesswire.com: https://www.businesswire.com/news/home/20240601902871/en/
Contact Genmab: David Freundel, Senior Director, Global
Communications & Corporate Affairs T: +1 609 430 2481; E:
dafr@genmab.com Andrew Carlsen, Vice President, Head of Investor
Relations T: +45 3377 9558; E: acn@genmab.com Contact
BioNTech: Media Relations Jasmina Alatovic +49 (0)6131 9084
1513 media@biontech.de Investor Relations Victoria Meissner, M.D.
+1 617 528 8293 investors@biontech.de
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