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 that it will host a conference call to discuss a business
update on Monday, October 16, 2023 at 7:30 a.m. ET.
Zenocutuzumab (Zeno or MCLA-128: HER2 x HER3
Biclonics®): NRG1 fusion (NRG1+) cancer and other solid
tumors
Today two abstracts were published on the European Society for
Medical Oncology Congress (ESMO) 2023 website. The abstracts
highlight updated interim clinical data from the ongoing phase 1/2
eNRGy trial and Early Access Program (EAP) of the bispecific
antibody zenocutuzumab (Zeno) in patients with neuregulin 1 fusion
(NRG1+) cancer. The Principal Investigator of the eNRGy trial, Dr.
Alison Schram of Memorial Sloan-Kettering Cancer Center will
present a mini oral session on NRG1+ NSCLC. The ESMO Congress 2023
will take place in Madrid, Spain October 20-24, 2023.
”Zeno continues to show remarkably consistent efficacy over
time, with robust and durable responses in these difficult-to-treat
indications,” said Dr. Andrew Joe, Chief Medical Officer at Merus.
“We recently met with the FDA in the context of our two
breakthrough therapy designations and based on these productive and
collaborative discussions, we believe we will have sufficient data
for both NRG1+ NSCLC and NRG1+ PDAC in the first half of 2024 to
support biologics license application submissions.”
Interim data included in the abstracts are from the phase 1/2
eNRGy trial and EAP which are assessing the safety and anti-tumor
activity of Zeno monotherapy in NRG1+ cancer. Updated data will be
provided in the presentations to include additional patients as
well as follow-up on safety and efficacy for the patients presented
in the abstracts:
Mini Oral Presentation Title: Durable efficacy
of zenocutuzumab, a HER2 x HER3 bispecific antibody, in advanced
NRG1 fusion-positive (NRG1+) non-small cell lung cancer
(NSCLC)
- Observations in the abstract include:
- As of a February 1, 2023 data cutoff date, 85 patients (pts)
with NRG1+ NSCLC were enrolled. 64 pts with measurable disease were
treated as of August 1, 2022 allowing for the potential for ≥ 6
months follow up and were evaluable for response
- 34% overall response rate (ORR) (95% CI, 23-47) by RECIST
v1.1. per investigator assessment
- 78% of pts had target lesion reduction
- 12.9 months median duration of response (DOR), with responses
ongoing in 50% of pts
- Among the 85 pts enrolled, Grade ≥ 3 adverse events (AEs)
irrespective of causality occurred in < 4% pts
Presentation Details:Session
Category: Mini oral session
1 Session: NSCLC,
metastatic Date: Saturday, October 21,
2023 Time: 9:35-9:40
CEST Presentation #: 1315MO
Poster Presentation Title: Durable efficacy of
zenocutuzumab, a HER2 x HER3 bispecific antibody, in advanced NRG1
fusion-positive (NRG1+) pancreatic ductal adenocarcinoma
(PDAC)
- Observations in the abstract include:
- As of a February 1, 2023 data cutoff date, 38 pts with NRG1+
PDAC were enrolled. 27 pts with measurable disease were treated as
of August 1, 2022 allowing for the potential for ≥ 6 months
follow-up and were evaluable for response
- 44% ORR (95% CI, 26-65) by RECIST v1.1. per investigator
assessment; including 1 complete response
- 81% of pts had target lesion reduction and 84% of pts had CA
19-9 decline of ≥ 50% from baseline
- 9.1 months median DOR, with responses ongoing in 33% of
pts
- Among the 38 pts enrolled, Grade ≥ 3 AEs irrespective of
causality occurred in < 5% pts
Presentation Details:Session:
Poster Session Date: Monday, October 23,
2023 Time: 9:00-17:00
CEST Presentation #: 1618P
As full presentations become available at the ESMO Congress
2023, they will contemporaneously be available on the Merus
website.
Merus is also evaluating Zeno in combination with androgen
deprivation therapy (enzalutamide or abiraterone) in men with
castration resistant prostate cancer, irrespective of NRG1+ status.
Merus plans to provide initial clinical data in the second half of
2023.
Petosemtamab (MCLA-158: EGFR x LGR5 Biclonics®): Solid
Tumors
Merus plans to initiate the phase 3 clinical trial in mid-2024
to evaluate petosemtamab monotherapy in previously treated
recurrent or metastatic head and neck squamous cell carcinoma
(HNSCC). Earlier this year in a presentation at the American
Association of Cancer Research Annual Meeting, interim clinical
data in this indication, having a data cutoff date of February 1,
2023, demonstrated the high and durable efficacy of petosemtamab
with a well-tolerated and manageable safety profile.
“We’re very excited to start enrolling the randomized phase 3
trial as we believe we have an opportunity to significantly improve
the outcomes of patients with head and neck cancer,” said Bill
Lundberg, M.D., President, Chief Executive Officer of Merus.
“Additionally, we are encouraged to report that among the initial
patients dosed in the front-line combination of petosemtamab with
Keytruda®, the safety profile has been observed to be generally
favorable with no dose limiting toxicities reported to date.”
In the planned phase 3 trial, patients will be randomized to
petosemtamab monotherapy or to investigators choice of single agent
chemotherapy or cetuximab. Data regarding the INTERLINK-1 trial was
released today ahead of the ESMO Congress 2023. Merus believes the
clinical activity of cetuximab monotherapy in patients with
recurrent or metastatic squamous cell carcinoma of the head and
neck who received prior platinum-based chemotherapy and a
PD-1/PD-L1 inhibitor, further supports the planned design of our
phase 3 clinical trial.
Merus continues to enroll approximately 40 patients with
previously treated HNSCC with petosemtamab monotherapy at the 1100
or 1500 mg dose levels to confirm a suitable dose for future
potential randomized trials. Merus plans to share the clinical
data from this cohort in 2024.
Merus also continues to enroll patients with previously
untreated advanced PD-L1+ HNSCC with petosemtamab 1500 mg in
combination with Keytruda®. Initial safety data from this single
arm cohort may support the initiation of a first-line registration
trial with this combination. Merus plans to report initial interim
safety and efficacy data from this cohort in the first half of
2024.
MCLA-129 (EGFR x c-MET Biclonics®): Solid
Tumors
Abstracts on the bispecific antibody MCLA-129 in NSCLC and in
previously treated HNSCC were selected for presentation at the ESMO
Asia Congress 2023 taking place in Singapore December 1-3,
2023.
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)
Title: Efficacy and safety of MCLA-129, an
anti-EGFR/c-MET bispecific antibody, in head and neck squamous cell
cancer (HNSCC)
Merus is discontinuing the NSCLC with EGFR exon20 mutation
cohort due to the competition in this niche market.
Company Conference Call and Webcast
Information
Merus will hold a conference call and webcast for investors on
October 16, 2023 at 7:30 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: October 16, 2023 at 7:30 a.m.
ETWebcast link: Available on our
websiteDial-in: Toll-Free: 1 (800) 715-9871 /
International: 1 (646) 307-1963Conference ID:
6064075
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://merus.nl/ and
https://twitter.com/MerusNV.
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 content and timing of clinical trials,
data readouts and clinical updates for our product candidates, our
belief on the impact of breakthrough therapy designations and FDA
interactions on future events for zenocutuzumab; the treatment
potential of our product candidates, their mechanism of action,
future clinical trial developments or interim analyses, or
statements about any future impact from evidence of clinical
activity, including of zenocutuzumab in NRG1+ cancer, NRG1+ NSCLC
or NRG1+ PDAC, and our belief that we will have sufficient data for
both NRG1+ NSCLC and NRG1+ PDAC in the first half of 2024 to
support biologics license application submissions; plans to
initiate the phase 3 clinical trial in mid-2024 to evaluate
petosemtamab monotherapy in previously treated recurrent or
metastatic HNSCC; the future potential safety and efficacy of
zenocutuzumab or petosemtamab alone or in combination with
Keytruda; the potential opportunity that petosemtamab may have to
significantly improve the outcomes of patients with head and neck
cancer; our belief that data from INTERLINK-1 trial further
supports a planned phase 3 trial; and updates planned for
petosemtamab in 2024 and beyond. 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 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 COVID-19 pandemic; 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 June 30, 2023 filed with the Securities and Exchange
Commission, or SEC, on August 3, 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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