Merus Presents Interim Data on MCLA-145 Monotherapy and in Combination with Pembrolizumab at the 2024 ASCO® Annual Meeting
2024年6月3日 - 1:30AM
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 updated interim clinical data on MCLA-145 monotherapy and
in combination with pembrolizumab were presented at the 2024
American Society of Clinical Oncology® (ASCO®) Annual Meeting
taking place in Chicago May 31-June 4, 2024.
“MCLA-145 as monotherapy or with pembrolizumab appears to have a
manageable safety profile and early clinical activity in these
difficult to treat cancers. Our biomarker data suggest that both
dose and less frequent administration may be important determinants
of clinical activity, and we are encouraged by the progress we are
making with MCLA-145,” said Bill Lundberg, M.D., President, Chief
Executive Officer of Merus. “As our company is now increasingly
focused on our lead asset petosemtamab and plan to initiate phase 3
trials in head and neck cancer later this year, we aim to advance
clinical development of MCLA-145 in the context of a potential
collaboration.”
MCLA-145 (CD137 x PD-L1 Biclonics®): Solid
Tumors Interim data included in the presentation describe
data from patients (pts) with advanced/metastatic solid tumors who
received MCLA-145 Q2W in 28 day cycles or every three weeks (Q3W)
in 21 day cycles. Pts treated with the combination of MCLA-145 and
pembrolizumab had cancers that either relapsed after PD-(L)1
therapies or were immunotherapy (IO) naïve.
Rapid oral presentation title: Phase I study of
MCLA-145, a bispecific antibody targeting CD137 and PD-L1, in solid
tumors, as monotherapy or in combination with
pembrolizumabObservations in the presentation include:
- As of a January 3, 2024 data cutoff date, 72 pts with multiple
cancer types were treated; 25% of pts had non-small cell lung
cancer (NSCLC)
- All patients were heavily pre-treated with a median of 3 prior
therapies; prior IO in 49% of the monotherapy pts and 100% of the
combination pts
- In monotherapy, 52 pts with a variety of tumor types and
treated at different dose levels were evaluable for response
- 5 partial responses (PRs) were observed at different dose
levels in glioblastoma (ongoing as of the cutoff date for >3
years), sarcoma (pretreated with pazopanib and
gemcitabine/docetaxel), cervical, anal, and gastric cancer by
Response Evaluation Criteria in Solid Tumors v1.1. per investigator
assessment
- 2 of 6 pts PRs (33%) were observed for pts treated at the
recommended dose for expansion (RDE), 40 mg Q3W
- 3 of 6 PRs (50%) were observed for pts with evaluable baseline
tumor CD8 T-cell density of ≥ 250 cells/mm2 responded
- In combination with pembrolizumab, 19 pts with a variety of
tumor types and treated at different dose levels were evaluable for
response
- 1 PR in Merkel cell carcinoma was observed at 25 mg Q3W
- 1 complete response was observed in PD-L1+ NSCLC at the RDE 40
mg Q3W
- 3 pts were continuing combination therapy at cutoff date
- MCLA-145 monotherapy or in combination with pembrolizumab had a
well-tolerated and manageable safety profile at the RDE, 40mg Q3W
- Shifting from Q2W to Q3W resulted in a 50% reduction of Grade
(G) ≥3 treatment-emergent adverse events in both monotherapy and
combination therapy
- Liver toxicity, a common CD137 related adverse event, was
controlled with no G4 events observed at Q3W
The full presentation is available on the Merus website.
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-145, 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®; our belief that for MCLA-145, biomarker data
suggest that both dose and less frequent administration may be
important determinants of clinical activity; our statements
concerning the progress we are making with MCLA-145; our
increasingly focus on our lead asset petosemtamab and plan to
initiate phase 3 trials in head and neck cancer later this year;
and our aim to advance clinical development of MCLA-145 in the
context of a potential collaboration. 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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