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 two abstracts regarding MCLA-129 on
the European Society for Medical Oncology (ESMO) Asia Congress
website. The abstracts highlight updated interim clinical data from
expansion cohorts in non-small cell lung cancer (NSCLC) and in
previously treated head and neck squamous cell carcinoma (HNSCC)
for presentation at the ESMO Asia Congress 2023 taking place in
Singapore December 1-3, 2023.
“MCLA-129 is now the third asset, together with our other
clinical assets petosemtamab and zenocutuzumab, developed from the
Merus proprietary Biclonics® platform to demonstrate strong
clinical activity,” said Bill Lundberg, M.D., President, Chief
Executive Officer of Merus. “As we continue the development of
MCLA-129, we are planning to take a disciplined capital allocation
approach, making focused investments in the program to identify
areas of potential differentiation. We remain open to potential
business development opportunities as a means to leverage added
resources, infrastructure and expertise of a potential partner to
more fully evaluate and develop MCLA-129.”
MCLA-129 (EGFR x c-MET Biclonics®): Solid
TumorsInterim data included in the abstracts describe data
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 and in EGFRm NSCLC
that has progressed on osimertinib, as well as MCLA-129 monotherapy
in previously treated HNSCC.
Updated clinical data, with additional patients and a later data
cutoff date, will be included in the mini-oral presentation on
NSCLC and the poster on HNSCC at ESMO Asia next week.
Mini-oral presentation title: 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 abstract include:
- As of a May 10, 2023 data cutoff date, 48 patients (pts) with
advanced/metastatic EGFRm NSCLC were treated (14/1L, 34/2L+)
- In the 1L setting, 14 pts were treated, with 10 pts evaluable
for response
- 2 confirmed partial responses (PRs) and 6 unconfirmed PRs were
observed (8/10, 80%; 95% CI 44-98) by Response Evaluation
Criteria in Solid Tumors (RECIST) v1.1. per investigator
assessment; all responses were ongoing as of the data cutoff
date
- 90% disease control rate (DCR) (95% CI 56-100)
- 10 weeks (range 2-26) median duration of exposure with 93%
continuing treatment
- In the 2L+ setting, 34 pts were treated, with 22 pts evaluable
for response
- All received prior osimertinib in 1L/2L setting, 71% as the
most recent therapy; 24% received prior chemotherapy
- 6 confirmed PRs and 5 unconfirmed PRs were observed (11/22,
50%; 95% CI 28-72) by RECIST v1.1. per investigator assessment; 9
responses were ongoing as of the data cutoff date, including 4 of
the unconfirmed PRs
- 82% DCR (95% CI 60-95)
- 10 weeks (range 2-38) median duration of exposure with 68%
continuing treatment
- Early safety assessment in 48 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 85% (6% ≥
grade(G) 3)
- Skin toxicity (composite term) in 75% (4% G3)
- Treatment related interstitial lung disease (ILD)/pneumonitis
in five patients (10%), two were G2, two were G3, and one was G5
and one progressed to G5 after the data cutoff date
- Venous thromboembolic (VTE) events in 15%; 4% treatment
related
Presentation Details: Session:
Thoracic Cancer Date: Sunday, December 3, 2023
Time: 9:40 -9:45 a.m. SGT Presentation
#: 516MO
Poster presentation title: Efficacy and safety
of MCLA-129, an anti-EGFR/c-MET bispecific antibody, in head and
neck squamous cell cancer (HNSCC) Observations in the abstract
include:
- As of a May 10, 2023 data cutoff date, 18 pts with previously
treated HNSCC were treated
- Pts received median of two lines prior therapy, 89% prior
chemotherapy, 78% prior anti-PD-(L)1, 28% prior cetuximab
- 12 pts were evaluable for response
- 2 unconfirmed PRs were observed (2/12, 17%) by RECIST v1.1. per
investigator assessment; one response was ongoing as of the data
cutoff date
- 67% DCR (95% CI 35-90%)
- 8 weeks (range 2-17) median duration of exposure with 50%
continuing on treatment
- Early safety assessment in 18 HNSCC pts treated with MCLA-129
monotherapy included
- Most common AEs regardless of causality were IRRs (composite
term) in 72% (28% ≥ G3), all on cycle 1 day 1, that led to
treatment discontinuation in two pts
- Skin toxicity in 61% (11% G3)
- No ILD or VTE events were
reported
Presentation details: Session
Category: Poster session Date:
Saturday, December 2, 2023 Time:
17:50-18:45 p.m. SGT Presentation #:
362P
MCLA-129 Development StrategyIn EGFRm NSCLC,
with the strong clinical activity for MCLA-129 shown in the interim
data presented today, we are encouraged by the potential for
MCLA-129 in the treatment of lung cancer and beyond. We have
identified focused investment opportunities. We continue to follow
patients with EGFRm NSCLC treated with MCLA-129 in combination with
osimertinib, to evaluate potential for biomarkers as a means to
maximize efficacy, while proactively addressing safety signals seen
to date.
We plan to start a cohort of MCLA-129 in combination with
chemotherapy in 2L+ EGFRm NSCLC in the first quarter of next
year.
Additionally, we remain interested and are continuing
investigation of cohort B evaluating MCLA-129 in patients with MET
exon14 skipping NSCLC. We also remain interested in exploring
partnering MCLA-129 with other companies to sufficiently resource
the development of MCLA-129 and potential benefit it may have for
patients.
In HNSCC, based on the interim data, we observed clinical
activity with MCLA-129. However, we view the clinical activity with
MCLA-129 monotherapy as of the cutoff date as modest, with 2
unconfirmed partial responses or 17%. The safety profile was
manageable, and there were no reported ILD or VTE events. Our
assessment of this cohort is that the clinical activity of MCLA-129
in second line head and neck cancer appears substantially inferior
to that of our lead asset petosemtamab, and only on par with other
EGFR or cetuximab-based monoclonal or bispecific antibodies as
monotherapy in a similar setting. We believe this efficacy is
insufficient to warrant further development in head and neck
cancer.
Zenocutuzumab (Zeno or MCLA-128: HER2 x HER3
Biclonics®): NRG1 fusion (NRG1+) cancer and other solid
tumorsAn abstract for an encore of a recent ESMO Congress
2023 presentation on zenocutuzumab interim clinical data from the
eNRGy trial and Early Access Program in patients with NRG1 fusion
(NRG1+) NSCLC has also been accepted for presentation at ESMO Asia.
Presentation details:
Title: Durable efficacy of zenocutuzumab, a
HER2 x HER3 bispecific antibody, in advanced NRG1 fusion-positive
(NRG1+) non-small cell lung cancer (NSCLC) Session
Category: Poster session Date:
Saturday, December 2, 2023 Time:
17:50-18:45 p.m. SGT Presentation #:
595P
As full presentations become available at the ESMO Asia Congress
2023, 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 November 27, 2023 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 and Time: November 27, 2023 at 8:00 a.m.
ETWebcast link: Available on our
websiteDial-in: Toll-Free: 1 (800) 715-9871 /
International: 1 (646) 307-1963Conference ID:
2833671
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 MCLA-129, future clinical trial progress,
enrollment, results, clinical activity and safety profile of
MCLA-129; our belief in MCLA-129 exhibiting strong clinical
activity; our plans to take a disciplined capital allocation
approach, making focused investments in the program to identify
areas of potential differentiation; our openness to potential
business development opportunities as a means to leverage added
resources, infrastructure and expertise of a potential partner to
more fully evaluate and develop MCLA-129; our development plans and
strategy for MCLA-129 including continuing to follow patients with
EGFR mutant non-small cell lung cancer treated with MCLA-129 in
combination with osimertinib, to evaluate potential for biomarkers
as a means to maximize efficacy, while proactively addressing
safety signals seen to date; our plan to start a cohort of MCLA-129
in combination with chemotherapy in 2L+ EGFRm NSCLC in the first
quarter of next year; our continuing investigation of cohort B
evaluating MCLA-129 in pts with MET exon14 skipping NSCLC; our
interest in exploring partnering MCLA-129 with other companies to
sufficiently resource the development of MCLA-129 and the potential
benefit it may have for patients; the safety profile of MCLA-129
and implications for future safety; and our belief that MCLA-129’s
activity in 2L+ HNSCC is insufficient to warrant further
development in head and neck cancer. 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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