Merus Announces Publication of an Abstract on Petosemtamab with Pembrolizumab as 1L treatment of r/m HNSCC at the 2024 ASCO® Annual Meeting
May 23 2024 - 5:00PM
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 the publication of an abstract regarding petosemtamab in
combination with pembrolizumab on the 2024 American Society of
Clinical Oncology® (ASCO®) Annual Meeting website. The
abstract presents interim clinical data from a cohort of 26
patients enrolled as of the abstract cutoff date, evaluating the
combination in first line (1L) recurrent/metastatic (r/m) head and
neck squamous cell carcinoma (HNSCC) for presentation at the 2024
ASCO® Annual Meeting taking place in Chicago, May 31-June 4, 2024.
The full dataset for these patients will be discussed on a
conference call on Tuesday, May 28 at 8:00 a.m. ET.
“We believe petosemtamab continues to demonstrate potential best
in class safety and efficacy in head and neck cancer. We are
encouraged with the well tolerated safety profile of the
combination of petosemtamab and pembrolizumab, particularly with a
low rate of Grade 3 or greater adverse events, and a low rate of
infusion-related reactions observed,” said Bill Lundberg, M.D.,
President, Chief Executive Officer of Merus. “These data in the
abstract provide encouraging efficacy albeit from an early cutoff
date, with less mature data. And we look forward to our conference
call, Tuesday May 28, to discuss the more mature clinical update
from a later cutoff date where the response rate further
improved.”
Petosemtamab (MCLA-158: EGFR x LGR5 Biclonics®): Solid
Tumors
Rapid oral presentation title: Petosemtamab
(MCLA-158) with pembrolizumab as first-line (1L) treatment of
recurrent/metastatic (r/m) head and neck squamous cell carcinoma
(HNSCC): Phase 2 study.Observations in the abstract
include:
- As of a November 6, 2023 data cutoff date, 26 patients (pts)
were treated; with 24 continuing therapy
- 10 pts were evaluable for response (≥2 cycles and ≥1
post-baseline scan, or early progressive disease [PD]) and 6
responses were observed. This included 1 confirmed complete
response, 2 confirmed partial responses, and 3 unconfirmed partial
responses (2 confirmed as of the abstract submission and the 3rd
also subsequently confirmed) by Response Evaluation Criteria in
Solid Tumors v1.1
- The combination was well tolerated and no significant
overlapping toxicities were observed. Treatment-emergent adverse
events were reported in all patients, most were Grade 1 or 2 in
severity. Infusion related reactions (composite term) were reported
in 26.9% (all Grades) of which 3.8% were Grade 3, and all occurred
during first infusion and resolved.
Presentation Details: Abstract
#: 6014 Session Title: Head and Neck
Cancer Session Date and
Time: June 3, 2024, 8:00-9:30 a.m.
CT
As full presentations become available at the 2024 ASCO® Annual
Meeting, they will contemporaneously be available on the Merus
website.
Company Conference Call and Webcast
InformationMerus will hold a conference call and webcast
for investors on Tuesday, May 28, 2024 at 8:00 a.m.
ET. A replay will be available after the completion of the call in
the Investors and Media section of our website for a
limited time.
Date & Time: May 28,
2024 at 8:00 a.m. ETWebcast
link: Available on our
websiteDial-in: Toll Free: 1 (800)
715-9871/ International: 1
(646) 307-1963Conference
ID: 4160163
About Merus N.V. 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, http://www.merus.nl and
https://twitter.com/MerusNV.
Forward-Looking StatementsThis 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 clinical
development of our clinical candidates, including petosemtamab,
future clinical trial results or interim data, clinical activity
and safety profile, and development plans in the on-going trials
and described in forthcoming posters or presentations; our belief
that petosemtamab continues to demonstrate potential best in class
safety and efficacy in head and neck cancer; the observations of
response rate and safety profile of the combination of petosemtamab
and pembrolizumab, and any impact on future patients treated with
this combination. These forward-looking statements are based on
management’s current expectations. 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 Biclonics®, Triclonics® and multispecific 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 market volatility; 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 Annual Report on Form 10-Q for the quarter
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.
Investor and Media Inquiries:
Sherri Spear
Merus N.V.
VP Investor Relations and Corporate Communications
617-821-3246
s.spear@merus.nl
Kathleen Farren
Merus N.V.
IR/Corp Comms
617-230-4165
k.farren@merus.nl
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