Merus Announces First Patient Dosed in LiGeR-HN2, a Phase 3 Trial Evaluating Petosemtamab in 2/3L r/m HNSCC
24 Juillet 2024 - 1:00PM
UK Regulatory
Merus Announces First Patient Dosed in LiGeR-HN2, a Phase 3 Trial
Evaluating Petosemtamab in 2/3L r/m HNSCC
Petosemtamab 1500 mg Q2W confirmed for both 2/3L phase 3
trial (LiGeR-HN2) and 1L trial (LiGeR-HN1) in r/m HNSCC following
FDA feedback
UTRECHT, The Netherlands and CAMBRIDGE, Mass., July
24, 2024 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS) (Merus, the
Company, we, or our), a clinical-stage oncology company developing
innovative, full-length multispecific antibodies
(Biclonics® and Triclonics®), today announced
that the first patient has been dosed in the Company’s phase 3
trial evaluating the efficacy and safety of petosemtamab, a
Biclonics® targeting EGFR and LGR5, compared to
investigator’s choice of single agent chemotherapy or cetuximab in
previously treated (2/3L) patients with recurrent/metastatic head
and neck squamous cell carcinoma (r/m HNSCC) referred to as the
LiGeR-HN2 trial.
Merus has confirmed through feedback with the U.S. Food and Drug
Administration (FDA) that petosemtamab 1500 mg every two weeks is
appropriate for further development in HNSCC as monotherapy, and in
combination with pembrolizumab.
“With petosemtamab’s strong clinical data in HNSCC and alignment
with the FDA on dose, we are excited to have treated our first
patient in the 2/3L phase 3 trial,” said Fabian Zohren, M.D.,
Ph.D., Chief Medical Officer of Merus. “We believe petosemtamab has
the potential to become the new standard of care across r/m
HNSCC.”
More details of the trial can be found
at clinicaltrials.gov.
About LiGeR-HN2
LiGeR-HN2, a phase 3 trial, will evaluate the safety and efficacy
of petosemtamab compared to investigator’s choice of methotrexate,
docetaxel, or cetuximab in 2/3L r/m HNSCC patients. The trial is
open to adult patients that have progressed on or after anti-PD-1
therapy and platinum-containing therapy. The primary endpoints are
overall response rate as assessed by BICR based on RECIST v1.1 and
overall survival. Secondary endpoints are duration of response and
progression free survival. Merus plans to enroll approximately 500
patients in the trial.
About Petosemtamab
Petosemtamab, or MCLA-158, is a Biclonics® low-fucose
human full-length IgG1 antibody targeting the epidermal growth
factor receptor (EGFR) and the leucine-rich repeat containing
G-protein-coupled receptor 5 (LGR5). Petosemtamab is designed to
exhibit three independent mechanisms of action including inhibition
of EGFR-dependent signaling, LGR5 binding leading to EGFR
internalization and degradation in cancer cells, and enhanced
antibody-dependent cell-mediated cytotoxicity (ADCC) and
antibody-dependent cellular phagocytosis (ADCP) activity.
About Head and Neck Cancer
Head and neck squamous cell carcinoma (HNSCC) describes a group of
cancers that develop in the squamous cells that line the mucosal
surfaces of the mouth, throat, and larynx. These cancers begin when
healthy cells change and grow in an unchecked manner, ultimately
forming tumors. HNSCC is generally associated with tobacco
consumption, alcohol use and/or HPV infections, depending on where
they develop geographically. HNSCC is the sixth most common cancer
worldwide and it is estimated that there were more than 930,000 new
cases and over 465,000 deaths from HNSCC globally in
2020.1 The incidence of HNSCC continues to rise and
is anticipated to increase by 30% to more than 1 million new cases
annually by 2030.2 HNSCC is a serious and
life-threatening disease with poor prognosis despite currently
available standard of care therapies.
1 Sung et al. CA Cancer J
Clin, 71:209-49,
2021; 2 Johnson,
D.E., Burtness,
B., Leemans, C.R. et al. Head and
neck squamous cell carcinoma.
Nat Rev Dis Primers 6, 92 (2020)
About Merus
Merus is a clinical-stage oncology company developing
innovative full-length human bispecific and trispecific antibody
therapeutics, referred to as Multiclonics®.
Multiclonics® are manufactured using industry
standard processes and have been observed in preclinical and
clinical studies to have several of the same features of
conventional human monoclonal antibodies, such as long half-life
and low immunogenicity. For additional information, please
visit Merus’ website, X and LinkedIn.
Forward-Looking Statements
This press
release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995. All
statements contained in this press release that do not relate to
matters of historical fact should be considered forward-looking
statements, including without limitation, statements regarding the
evaluation of petosemtamab in patients with HNSCC in monotherapy
and in combination with pembrolizumab, our belief, through feedback
with the U.S. FDA, that petosemtamab 1500 mg every two weeks is
appropriate for further development in HNSCC as monotherapy, and in
combination with pembrolizumab; and our belief in alignment with
the FDA on dose, our excitement to having treated our first patient
in the 2/3L phase 3 trial; and belief that petosemtamab has the
potential to become a new standard of care treatment for r/m HNSCC;
and that the incidence of HNSCC continues to rise and is
anticipated to increase by 30% to more than 1 million new cases
annually by 2030. These forward-looking statements are based on
management’s current expectations. These statements are neither
promises nor guarantees, but involve known and unknown risks,
uncertainties and other important factors that may cause our actual
results, performance or achievements to be materially different
from any future results, performance or achievements expressed or
implied by the forward-looking statements, including, but not
limited to, the following: our need for additional funding, which
may not be available and which may require us to restrict our
operations or require us to relinquish rights to our technologies
or antibody candidates; potential delays in regulatory approval,
which would impact our ability to commercialize our product
candidates and affect our ability to generate revenue; the lengthy
and expensive process of clinical drug development, which has an
uncertain outcome; the unpredictable nature of our early stage
development efforts for marketable drugs; potential delays in
enrollment of patients, which could affect the receipt of necessary
regulatory approvals; our reliance on third parties to conduct our
clinical trials and the potential for those third parties to not
perform satisfactorily; impacts of the volatility in the global
economy, including global instability, including the ongoing
conflicts in Europe and the Middle East; we may not identify
suitable Biclonics® or bispecific antibody candidates
under our collaborations or our collaborators may fail to perform
adequately under our collaborations; our reliance on third parties
to manufacture our product candidates, which may delay, prevent or
impair our development and commercialization efforts; protection of
our proprietary technology; our patents may be found invalid,
unenforceable, circumvented by competitors and our patent
applications may be found not to comply with the rules and
regulations of patentability; we may fail to prevail in potential
lawsuits for infringement of third-party intellectual property; and
our registered or unregistered trademarks or trade names may be
challenged, infringed, circumvented or declared generic or
determined to be infringing on other marks. These and other
important factors discussed under the caption “Risk Factors” in our
Quarterly Report on Form 10-Q for the period ended March 31, 2024,
filed with the Securities and Exchange Commission, or SEC, on May
8, 2024, and our other reports filed with the SEC, could cause
actual results to differ materially from those indicated by the
forward-looking statements made in this press release. Any such
forward-looking statements represent management’s estimates as of
the date of this press release. While we may elect to update such
forward-looking statements at some point in the future, we disclaim
any obligation to do so, even if subsequent events cause our views
to change, except as required under applicable 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.
Multiclonics®, Biclonics® and
Triclonics® are registered trademarks of Merus N.V.
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