Merus Presents Interim Data on MCLA-129 at ESMO Asia Congress 2023
03 Dicembre 2023 - 2:40AM
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-129 from
ongoing expansion cohorts in non-small cell lung cancer (NSCLC) and
in previously treated head and neck squamous cell carcinoma (HNSCC)
were presented at the European Society for Medical Oncology (ESMO)
Asia Congress 2023.
“MCLA-129 is a very active drug in EGFRm NSCLC and we’re
planning a focused investment to evaluate MCLA-129 in combination
with chemotherapy, which we expect to start early in 2024,” said
Bill Lundberg M.D., President, Chief Executive Officer of Merus.
“We are in a fortunate position to have a strong balance sheet. We
also recognize the importance of being responsible with our
resources to maintain financial strength, as we plan to initiate a
phase 3 trial of petosemtamab in 2L+ HNSCC by
mid-2024.”
The reported data are from three expansion cohorts in the open
label trial evaluating MCLA-129 in combination with osimertinib, a
third generation EGFR TKI, in treatment-naïve EGFR mutant (m) NSCLC
(1L) and in EGFRm NSCLC that has progressed on osimertinib (2L+),
as well as MCLA-129 monotherapy in previously treated HNSCC.
Efficacy and safety of MCLA-129, an EGFR x c-MET
bispecific antibody, combined with osimertinib, as first-line
therapy or after progression on osimertinib in non-small cell lung
cancer (NSCLC)
Observations in the presentation include:
- As of an August 10, 2023 data cutoff date, 60 patients (pts)
with advanced/metastatic EGFRm NSCLC were treated (16/1L,
44/2L+)
- In the 1L setting, 16 pts were treated, with all pts evaluable
for response
- All 16 pts experienced tumor
shrinkage
- 9 confirmed partial responses (PRs)
and 3 unconfirmed PRs were observed (12/16, 75%; 95% CI 48-93) by
Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. per
investigator assessment; 11 responses were ongoing, including the 3
unconfirmed PRs
- 94% disease control rate (DCR) (95%
CI 70-100)
- 5.1 months (range 0.5-8.5) median
duration of exposure with 81% continuing treatment
- In the 2L+ setting, 44 pts were
treated, with 34 pts evaluable for response
- All received prior osimertinib in
the 1L/2L setting, 50% as only prior therapy; 36% received prior
chemotherapy
- 11 confirmed PRs and 1 unconfirmed
PR were observed (12/34, 35%; 95% CI 20-54) by RECIST v1.1. per
investigator assessment, 9 responses were ongoing as of the data
cutoff date, including the 1 unconfirmed PR
- 74% DCR (95% CI 56-87)
- 2.8 months (range: 0.3-11.5) median
duration of exposure with 39% continuing treatment
- Early safety assessment in 60 NSCLC pts treated with MCLA-129
plus osimertinib included
- Most common adverse events (AEs) regardless of causality were
infusion related reactions (IRRs; composite term) in 87% (12% ≥
grade(G) 3)
- Treatment emergent adverse events
(TEAEs) led to discontinuations in 14 (23%) pts
- Treatment related interstitial lung
disease (ILD)/pneumonitis in 13 pts (22%), four were G1, two were
G2, four were G3, and three were G5
- Venous thromboembolic (VTE) events
in 23%; 5% treatment related
Efficacy and safety of MCLA-129, an anti-EGFR/c-MET
bispecific antibody, in head and neck squamous cell cancer
(HNSCC)
Observations in the presentation include:
- As of an August 10, 2023 data cutoff date, 22 pts with
previously treated HNSCC were treated
- 20 pts were evaluable for response
- Pts received a median of 3 lines of prior therapy, 22% prior
chemotherapy, 20% prior anti-PD-(L) 1, 36% prior cetuximab
- 1 confirmed and 1 unconfirmed PR were observed (2/20, 10%, 95%
CI 1–32) by RECIST v1.1. per investigator assessment
- The confirmed response was ongoing with a duration of response
of 3.4+ months at data cutoff date
- The unconfirmed PR was confirmed after the data cutoff date
with treatment still ongoing at the time of presentation
- 60% DCR (95% CI 36–81)
- 2.2 months (range 0.5–6) median duration of exposure
- Early safety assessment in 22 HNSCC pts treated with MCLA-129
monotherapy included
- IRRs (composite term) in 73% (14% ≥ G3) all on cycle 1 day
1
- Skin toxicity (composite term) in 86% (14% ≥ G3)
- No ILD or VTE events were reported
- No G5 TEAEs were reported
The full presentations are available on the Publications page of
our website.
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.
About MCLA-129MCLA-129 is an antibody-dependent
cellular cytotoxicity-enhanced Biclonics® that is designed to
inhibit the EGFR and c-MET signaling pathways in solid tumors.
Preclinical data have shown that MCLA-129 can effectively treat
TKI-resistant NSCLC in xenograft models of cancer. MCLA-129 is
designed to have two complementary mechanisms of action: blocking
growth and survival pathways to stop tumor expansion and
recruitment and enhancement of immune effector cells to eliminate
the tumor.
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 clinical development of MCLA-129, future clinical
trial progress, enrollment, results, clinical activity and safety
profile of MCLA-129; our belief that MCLA-129 is a very active drug
in EGFRm NSCLC; our plans to make a focused investment to evaluate
MCLA-129 in combination with chemotherapy, which we expect to start
early in 2024; our balance sheet and impact on future activities;
our plan to initiate a phase 3 trial of petosemtamab in 2L+ HNSCC
by mid-2024; and our development plans and strategy for MCLA-129.
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 clinical development efforts for marketable drugs;
potential delays in enrollment of patients, and our reliance on
third parties to conduct our clinical trials, manufacturing and
accompanying activities for clinical drug development and potential
approval and the potential for those third parties to not perform
satisfactorily, which could affect the receipt of necessary
regulatory approvals; impacts of the COVID-19 pandemic and global
instability; 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 September 30, 2023 filed with the Securities and Exchange
Commission, or SEC, on November 2, 2023, 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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