Merus’ Petosemtamab in Combination with Pembrolizumab Interim Data Demonstrates Robust Response Rate and Favorable Safety Profile in 1L r/m HNSCC
28 Maggio 2024 - 1:00PM
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 interim clinical data as of a March 6, 2024 data cutoff
from the ongoing phase 1/2 trial of the bispecific antibody
petosemtamab in combination with pembrolizumab. These data will be
presented by Dr. Jerome Fayette M.D. Ph.D., Centre Léon Bérard,
Lyon, France at the 2024 American Society of Clinical Oncology®
(ASCO®) Annual Meeting on Monday, June 3 at 8 a.m. CT.
“In this interim dataset, petosemtamab in combination with
pembrolizumab has demonstrated clinically meaningful activity in
first line head and neck cancer, with a 67% response rate overall,
observed across tumor PD-L1 expression levels and HPV status and
with encouraging safety," said Bill Lundberg, M.D., President,
Chief Executive Officer of Merus. “I’m excited to announce plans to
initiate a phase 3 registration trial of petosemtamab in
combination with pembrolizumab, regardless of HPV status, in first
line, PD-L1 expressing, head and neck cancer, which we expect will
start by year end 2024.”
“Despite recent advancements, head and neck squamous cell
carcinoma remains a deadly disease with limited treatment options,”
added Dr. Fayette. “Based on these data, I’m optimistic
petosemtamab, in combination with pembrolizumab, has the potential
to become a new standard of care for patients with previously
untreated head and neck cancer.”
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 presentation
include:
- As of a March 6, 2024 data cutoff date, 45 patients (pts) were
treated
- 26 patients were enrolled as of the abstract cutoff date
- The efficacy population consisted of 24 patients who had the
opportunity for 4 or more months follow up, with ≥2 treatment
cycles and ≥1 post-baseline tumor assessment; or
who discontinued early due to disease progression or death
- Two patients were not included: One patient withdrew consent
prior to first tumor assessment and the other patient discontinued
due to toxicity with less than 2 cycles of
treatment
- Response rates overall (N=24): 67%, including 1 confirmed
complete response, 12 confirmed partial responses (PRs) and 3
unconfirmed PRs (all of whom confirmed after the data cutoff) by
Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. per
investigator assessment, including
- 3 of 4 patients with HPV associated cancer responded
- Responses observed across PD-L1 levels (CPS 1-19: 60% [6/10];
CPS ≥ 20: 71% [10/14])
- At the time of data cutoff, 32 patients of the 45
enrolled, remained on treatment, including 14 of 16 responders
and 18 of the initial 26 patients enrolled
- Median follow up of 3.6 months for the 45 patients
- In 45 patients the combination was well tolerated and no
significant overlapping toxicities with pembrolizumab were
observed
- Treatment-emergent adverse events (AEs) were reported in 45 pts
- Most were Grade (G) 1 or 2 in severity (no G4–5 were
observed)
- Infusion-related reactions (composite term) were reported in
38% (all Gs) and 7% (G3) of pts, most occurred during the 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, https://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 presentation; our belief that in this
interim dataset, petosemtamab in combination with pembrolizumab has
demonstrated clinically meaningful activity in first line head and
neck cancer with encouraging safety; our plans to initiate a phase
3 registration trial of petosemtamab in combination with
pembrolizumab, regardless of HPV status, in first line, PD-L1
expressing, head and neck cancer, which we expect will start by
year end 2024; and the potential for petosemtamab in combination
with pembrolizumab to become a new standard of care in 1L head and
neck cancer. 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
Grafico Azioni Merus NV (NASDAQ:MRUS)
Storico
Da Dic 2024 a Gen 2025
Grafico Azioni Merus NV (NASDAQ:MRUS)
Storico
Da Gen 2024 a Gen 2025