* Initial data from the ongoing Phase 2 trial showed a 12-month overall
survival rate of 69% and a median overall survival of 17.5 months in
patients with previously treated PD-L1-positive metastatic non-small cell
lung cancer treated with a combination of acasunlimab and 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
COPENHAGEN, Denmark, and MAINZ, Germany, June 1, 2024 - Genmab A/S
(https://www.genmab.com/) (Nasdaq: GMAB, "Genmab") and BioNTech SE
(https://www.biontech.com/) (Nasdaq: BNTX, "BioNTech") today announced initial
data from the ongoing Phase 2 trial (NCT05117242
(https://clinicaltrials.gov/study/NCT05117242?intr=Acasunlimab&rank=2))
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 PD-L(1)-positive metastatic non-small cell lung
cancer ("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 the 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 held in Chicago, IL from
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 OS was evaluated in all centrally
confirmed PD-L1-positive patients (n=80). Arm A showed a mOS rate of 5.5 months,
a 50% disease control rate (DCR) and a 31% ORR (confirmed ORR 13%) in patients
treated with acasunlimab alone. An 8.6 months mOS, a 59% DCR and a 21% ORR
(confirmed ORR 18%) for treatment of acasunlimab in combination with
pembrolizumab every three weeks (Arm B) and a 17.5 months mOS, a 75% DCR and a
30% ORR (confirmed ORR 17%) when the combination was administered every six
weeks (Arm C). Anti-tumor activity was observed in patients with a tumor
proportion score ("TPS") of 1-49% and >=50%, in patients with =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 the
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 regimen therapy administered every six weeks. Transaminase
elevations were generally asymptomatic and manageable with the administration of
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 at 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 pretreated patient
population."
About the GCT1046-04 Clinical Trial
The GCT1046-04 trial (NCT05117242
(https://www.clinicaltrials.gov/study/NCT05117242?term=NCT05117242&rank=1)) 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 a tumor PD-L1
expression in >=1% of the tumor cells are included in the study. The primary
endpoint of the trial is the 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 can be found at clinicaltrials.gov
(http://www.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 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 survival rate of patients with NSCLC varies
depending on the stage at diagnosis.(i)(,ii,iii,)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.
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 cells, which is strictly dependent on simultaneous binding of the
PD-L1 arm. Acasunlimab is being developed in collaboration by BioNTech and
Genmab under a license and collaboration agreement. The candidate is currently
being investigated in three clinical trials: (1) a Phase 1/2 safety 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
(https://www.globenewswire.com/Tracker?data=Pxrb0jBGEpZVp5eQVRx92jNkmaVSsts0_Mld
rdZ96_VEBSpwK86DMOhrQEQ7wJMOQrfb4EOk4fpGk74y49QyYw==)?and follow us on LinkedIn
(https://www.linkedin.com/company/genmab) and X (https://twitter.com/Genmab).
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 preclinical 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 products,
our inability to manage growth, the competitive environment in relation to our
business area and markets, our inability to attract and retain suitably
qualified personnel, the unenforceability or lack of protection of our patents
and proprietary rights, our relationships with affiliated entities, changes and
developments in technology which may render our products or technologies
obsolete, and other factors. For a further discussion of these risks, please
refer to the risk management sections in Genmab's most recent financial reports,
which are available on www.genmab.com (http://www.genmab.com/) and the risk
factors included in Genmab's most recent Annual Report on Form 20-F and other
filings with the U.S. Securities and Exchange Commission (SEC), which are
available at www.sec.gov (https://www.sec.gov/edgar.shtml). 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: Genmab(®); the
Y-shaped Genmab logo(®); Genmab in combination with the Y-shaped Genmab logo(®);
HuMax(®); DuoBody(®); HexaBody(®); DuoHexaBody(®), HexElect(® )and KYSO(TM).
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 (http://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
terminology such as "will," "may," "should," "expects," "intends," "plans,"
"aims," "anticipates," "believes," "estimates," "predicts," "potential,"
"continue," or the negative of these terms or other comparable terminology,
although not all forward-looking statements contain these words.
The forward-looking statements in this press release are based on BioNTech's
current expectations and beliefs of future events, and are neither promises nor
guarantees. You should not place undue reliance on these forward-looking
statements because they involve known and unknown risks, uncertainties, and
other factors, many of which are beyond BioNTech's control and which could cause
actual results to differ materially and adversely from those expressed or
implied by these forward-looking statements. These risks and uncertainties
include, but are not limited to: the uncertainties inherent in research and
development, including the ability to meet anticipated clinical endpoints,
commencement and/or completion dates for clinical trials, regulatory submission
dates, regulatory approval dates 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 preclinical, clinical
or safety data; the nature of clinical data, which is subject to ongoing peer
review, regulatory review and market interpretation; the ability to produce
comparable clinical 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 manufactured by BioNTech; BioNTech's and its
collaborators' ability to commercialize and market, if approved, its product
candidates; BioNTech's ability to manage its development and expansion;
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.
CONTACTS
Genmab
Media Contact
David Freundel
+1 609 430 2481
dafr@genmab.com (mailto:dafr@genmab.com)
Investor Relations
Andrew Carlsen
+45 3377 9558
acn@genmab.com (mailto:acn@genmab.com)
BioNTech
Media Relations
Jasmina Alatovic
+49 (0)6131 9084 1513
media@biontech.de (mailto:media@biontech.de)
Investor Relations
Victoria Meissner, M.D.
+1 617 528 8293
investors@biontech.de (mailto:investors@biontech.de)
--------------------------------------------------------------------------------
(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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