Merus’ MCLA-129 Demonstrates Promising Single-Agent Efficiency in METex14 NSCLC in Poster Presentation at the 2024 ASCO® Annual Meeting
03 Giugno 2024 - 8:30PM
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 a poster regarding MCLA-129 presented
at the 2024 American Society of Clinical Oncology® (ASCO®) Annual
Meeting taking place in Chicago May 31-June 4, 2024.
“These data continue to support our view that MCLA-129 is a very
active drug, and that our Biclonics® platform really can create
clinically active drugs for patients with cancer. We plan to start
a cohort investigating MCLA-129 in combination with chemotherapy in
2L+ EGFRm NSCLC later this year,” said Bill Lundberg, M.D.,
President, Chief Executive Officer of Merus. “We continue to
evaluate MCLA-129 with a focused investment and remain interested
in a partnership to resource the further development of this
asset.”
Poster presentation title: Efficacy and safety
of MCLA-129, an anti-EGFR/c-MET bispecific antibody, in
non-small-cell lung cancer (NSCLC) with Hepatocyte Growth Factor
Receptor (c-MET) exon 14 skipping mutations (METex14)
Observations in the presentation include:
- As of a February 16, 2024 data
cutoff date, 22 patients (pts) were treated and 14 pts (64%) were
continuing treatment
- All the pts received MCLA-129 in monotherapy at the dose of
1500 mg, every 2 weeks
- Pts received a median of 2 lines of
prior therapy
- 10 pts (45%) were tyrosine kinase
inhibitor (TKI)-naïve and 12 (55%) had received prior TKIs
- 7 pts were excluded from the efficacy
population. 4 discontinued due to AEs <2 cycles of
treatment and did not experience progressive disease while on
study; 3 were ongoing as of the cutoff date with <2 treatment
cycles
- 15 pts were evaluable for response
having received ≥2 treatment cycles, measurable disease at baseline
and ≥1 post-baseline scan
- Response rate overall: 3 partial
responses (PRs) and 6 unconfirmed PRs (uPRs) were observed by
Response Evaluation Criteria in Solid Tumors v1.1 per investigator
assessment; 5 of the 6 uPRs were confirmed and 1 uPR progressed
after the data cutoff (8/15 confirmed PRs [53%])
- 6 of 8 TKI-naïve cancers responded, one of which was an initial
uPR that progressed after data cutoff
- 3 of 7 cancers with prior MET TKI responded
- Reduction in target lesion tumor
size from baseline was demonstrated in 12 pts (80%)
- Early safety assessment in 22 pts
treated with MCLA-129 monotherapy included
- Infusion related reactions (composite
term) in 86% (18% ≥ Grade (G)3)
- One pt had treatment-related
interstitial lung disease (G2)
- Venous thromboembolism was recorded in
2 pts (1 G3 possibly treatment-related, the other G2 and not
related to treatment)
The full presentation is available on the Publications page of
our website.
MCLA-129 is subject to a collaboration and license agreement
with Betta Pharmaceuticals Co. Ltd. (Betta), which permits Betta to
develop MCLA-129 and potentially commercialize exclusively
in China, while Merus retains global rights outside
of China. An abstract sponsored by Betta entitled: Efficacy
and safety of MCLA-129, an EGFR/c-MET bispecific antibody, in
advanced non-small cell lung cancer (NSCLC) was accepted for
poster presentation at 2024 ASCO®.
About MerusMerus 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 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 MCLA-129, 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; the ability of
our Mutliclonics® platforms; our belief that these data continue to
support our view that MCLA-129 is a very active drug for patients
with cancer; our plans to start a cohort investigating MCLA-129 in
combination with chemotherapy in 2L+ EGFR mutant NSCLC in 2024; and
our continued evaluation MCLA-129 with a focused investment and
interest in a partnership to resource the further development of
this asset. 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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