TARRYTOWN, N.Y., Dec. 11, 2021 /PRNewswire/ --
Includes latest data for REGN5458, including in highest dose
levels (200-800 mg)
Among patients who responded across all dose groups (3-800
mg), there was a 90% probability of being event-free (i.e., alive
without disease progression) 8 months from the time of
response
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today
announced new results for higher dose level cohorts of its
investigational REGN5458 (BCMAxCD3) bispecific antibody, which were
presented in an oral session at the 2021 American Society of
Hematology (ASH) Annual Meeting in Atlanta, GA. The new results from the Phase 1
portion of the Phase 1/2 trial in patients with relapsed/refractory
multiple myeloma found a 51% overall response rate (ORR) across all
dose groups, rising to 75% in patients who received higher doses of
REGN5458 (200-800 mg).
"Patients with multiple myeloma often face a long and
challenging journey, with most becoming refractory to multiple
lines of therapy over time," said Jeffrey
Zonder, M.D., Professor of Oncology at the Karmanos Cancer
Institute, MI, and a trial investigator. "Today's REGN5458 data
show promising response rates, particularly at the higher dose
levels, in patients with a high disease burden and highly
refractory disease who otherwise would have very limited options
available."
REGN5458 is a bispecific antibody designed to bind to BCMA on
multiple myeloma cells and the CD3 receptor on T-cells in order to
bridge them together and activate T-cells to kill the cancer cells.
It is currently being assessed in the potentially registrational
Phase 2 portion of the trial, which is expected to complete
recruitment in 2022.
In results presented at ASH today, 73 patients were treated with
REGN5458 doses ranging from 3-800 mg for up to 21 months at the
time of data cutoff. Patients had received a median of 5 prior
lines of therapy, with 38% (n=28) being penta-refractory and 90%
(n=66) being refractory to the last line of therapy.
The ORR was 75% at the highest dose levels (200-800 mg,
n=18/24), and 51% among all enrolled patients (n=37/73). Most
responses occurred within the first month of treatment and deepened
over time. Among responders across all dose groups:
- 86% (n=32/37) achieved a very good partial response (VGPR) or
better.
- 43% (n=16/37) achieved a complete response (CR), with 40% of
evaluable CR patients (n=4/10) being minimal residual disease (MRD)
negative.
- 8 months from the time of response, there was a 90% probability
of being event-free (95% CI: 73%, 97%), defined by the absence of
disease progression or death. The estimated median duration of
response had not yet been reached at the time of data cutoff.
- Responses occurred rapidly, usually within the first month of
treatment, and continue to deepen with longer treatment; the higher
dose groups currently have substantially shorter follow up.
The safety profile was generally consistent across all dose
levels. Cytokine release syndrome (CRS) was reported in 38% of
patients (n=28), the majority of which were Grade 1 (n=25), with no
cases >Grade 3. The other most common treatment-emergent adverse
events (TEAEs) were fatigue (n=33), pyrexia (n=26), nausea (n=24)
and anemia (n=23). The most common >Grade 3 TEAEs were anemia
(n=17), neutropenia (n=16), lymphopenia (n=14), thrombocytopenia
(n=10) and pneumonia (n=9). There were 5 deaths in the trial, all
due to infection; none were considered related to the underlying
disease by investigators.
"In multiple myeloma, the highest treatment response rates are
typically seen earlier in the course of the disease, using
multi-drug regimens. It is very encouraging that we observed a 75%
response rate with higher doses of REGN5458 monotherapy in patients
with more advanced disease," said L. Andres
Sirulnik, M.D., Ph.D., Senior Vice President, Clinical
Development, Hematology at Regeneron. "This adds to the growing
body of encouraging data across our investigational CD3
bispecifics, supporting the continued development of this class
across a diverse range of blood cancers."
REGN5458 is currently under clinical development and its safety
and efficacy have not been fully evaluated by any regulatory
authority.
Investor Webcast Information
Regeneron will host a
conference call and simultaneous webcast to share updates on the
company's hematology portfolio on Monday, December 13 at
4:30 PM ET. To access this call, dial
(888) 660-6127 (U.S.) or (973) 890-8355 (International); conference
ID 2668896. A link to the webcast may be accessed from the
'Investors and Media' page of Regeneron's website at
http://investor.regeneron.com/events.cfm. A replay of the
conference call and webcast will be archived on the company's
website for at least 30 days.
About the Dose-escalation Trial
The open-label Phase
1/2 dose-escalation trial is investigating REGN5458 (BCMAxCD3) in
patients with relapsed/refractory multiple myeloma who had received
at least three prior lines of therapy or were double refractory.
All patients had received prior treatment with proteasome
inhibitors, immunomodulatory drugs and CD38 antibody
treatments.
The Phase 1 portion of the trial is primarily assessing safety,
tolerability and dose-limiting toxicities of REGN5458, with
efficacy as secondary endpoints. The Phase 2 portion will further
assess REGN5458 anti-tumor activity and safety. If you are
interested in learning more about this trial, please contact us
(clinicaltrials@regeneron.com, +1 844 734 6643), or visit our
clinical trial website.
About Multiple Myeloma
Multiple myeloma is the second
most common blood cancer with approximately 30,192 and 168,765 new
diagnoses in the U.S. and the world, respectively, in 2020. It is
characterized by the proliferation of cancerous plasma cells
(multiple myeloma cells) that crowd out healthy blood cells in the
bone marrow, infiltrate other tissues and cause potentially
life-threatening organ injury. Multiple myeloma is not curable
despite treatment advances, and while current treatments are able
to slow the progression of the cancer, most patients will
ultimately experience cancer progression and require additional
therapies. In addition, patients are at increased risk of frequent
infections, bone problems, reduced kidney function and anemia.
About Regeneron in Hematology
At Regeneron, we're
translating more than 3 decades of biology expertise with our
proprietary VelociSuite® technologies to develop
potentially paradigm-changing medicines for patients with diverse
blood cancers and rare blood disorders.
Our blood cancer research is focused on bispecific antibodies
that are being assessed both as monotherapies and in combination
with each other and emerging therapeutic modalities. Together, they
provide us with unique combinatorial flexibility to develop
customized and potentially synergistic cancer treatments.
Our research and collaborations to develop potential treatments
for rare blood disorders include explorations in antibody medicine,
gene editing using CRISPR and gene-knockout technologies, as well
as investigational RNA-approaches that are being investigated for
their ability to deplete abnormal proteins or block disease-causing
cellular signaling.
For more information,
visit https://www.regeneron.com/pipeline.
About Regeneron's VelocImmune Technology
Regeneron's
VelocImmune® technology utilizes a proprietary
genetically engineered mouse platform endowed with a genetically
humanized immune system to produce optimized fully human
antibodies. When Regeneron's President and Chief Scientific Officer
George D. Yancopoulos was a graduate
student with his mentor Frederick W.
Alt in 1985, they were the first to envision making
such a genetically humanized mouse, and Regeneron has spent decades
inventing and developing VelocImmune and related
VelociSuite technologies. Dr. Yancopoulos and his team have
used VelocImmune technology to create approximately a
quarter of all original, FDA-approved or authorized fully human
monoclonal antibodies currently available. This includes
Dupixent® (dupilumab), REGEN-COV®
(casirivimab and imdevimab), Libtayo® (cemiplimab-rwlc),
Praluent® (alirocumab), Kevzara® (sarilumab),
Evkeeza® (evinacumab-dgnb) and
Inmazeb™ (atoltivimab, maftivimab, and
odesivimab-ebgn).
About Regeneron
Regeneron (NASDAQ: REGN) is a leading
biotechnology company that invents life-transforming medicines for
people with serious diseases. Founded and led for over 30 years by
physician-scientists, our unique ability to repeatedly and
consistently translate science into medicine has led to nine
FDA-approved treatments and numerous product candidates in
development, almost all of which were homegrown in our
laboratories. Our medicines and pipeline are designed to help
patients with eye diseases, allergic and inflammatory diseases,
cancer, cardiovascular and metabolic diseases, pain, hematologic
conditions, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug
development process through our proprietary VelociSuite
technologies, such as VelocImmune, which uses unique
genetically humanized mice to produce optimized fully human
antibodies and bispecific antibodies, and through ambitious
research initiatives such as the Regeneron Genetics Center, which
is conducting one of the largest genetics sequencing efforts in the
world.
For additional information about the company, please visit
www.regeneron.com or follow @Regeneron on Twitter.
Forward-Looking Statements and Use of Digital Media
This press release includes forward-looking statements that
involve risks and uncertainties relating to future events and the
future performance of Regeneron Pharmaceuticals, Inc. ("Regeneron"
or the "Company"), and actual events or results may differ
materially from these forward-looking statements. Words such as
"anticipate," "expect," "intend," "plan," "believe," "seek,"
"estimate," variations of such words, and similar expressions are
intended to identify such forward-looking statements, although not
all forward-looking statements contain these identifying words.
These statements concern, and these risks and uncertainties
include, among others, the impact of SARS-CoV-2 (the virus that has
caused the COVID-19 pandemic) on Regeneron's business and its
employees, collaborators, and suppliers and other third parties on
which Regeneron relies, Regeneron's and its collaborators' ability
to continue to conduct research and clinical programs, Regeneron's
ability to manage its supply chain, net product sales of products
marketed or otherwise commercialized by Regeneron and/or its
collaborators or licensees (collectively, "Regeneron's Products"),
and the global economy; the nature, timing, and possible success
and therapeutic applications of Regeneron's Products and product
candidates being developed by Regeneron and/or its collaborators or
licensees (collectively, "Regeneron's Product Candidates") and
research and clinical programs now underway or planned, including
without limitation REGN5458 (a BCMAxCD3 bispecific antibody) and
other blood cancer and rare blood disorder programs; the
likelihood, timing, and scope of possible regulatory approval and
commercial launch of Regeneron's Product Candidates and new
indications for Regeneron's Products, such as REGN5458 for the
treatment of multiple myeloma; uncertainty of the utilization,
market acceptance, and commercial success of Regeneron's Products
and Regeneron's Product Candidates and the impact of studies
(whether conducted by Regeneron or others and whether mandated or
voluntary), including the study discussed in this press release, on
any of the foregoing or any potential regulatory approval of
Regeneron's Products and Regeneron's Product Candidates (such as
REGN5458); the ability of Regeneron's collaborators, licensees,
suppliers, or other third parties (as applicable) to perform
manufacturing, filling, finishing, packaging, labeling,
distribution, and other steps related to Regeneron's Products and
Regeneron's Product Candidates; the ability of Regeneron to
manufacture and manage supply chains for multiple products and
product candidates; safety issues resulting from the administration
of Regeneron's Products and Regeneron's Product Candidates in
patients, including serious complications or side effects in
connection with the use of Regeneron's Products and Regeneron's
Product Candidates in clinical trials; determinations by regulatory
and administrative governmental authorities which may delay or
restrict Regeneron's ability to continue to develop or
commercialize Regeneron's Products and Regeneron's Product
Candidates; ongoing regulatory obligations and oversight impacting
Regeneron's Products, research and clinical programs, and business,
including those relating to patient privacy; the availability and
extent of reimbursement of Regeneron's Products from third-party
payers, including private payer healthcare and insurance programs,
health maintenance organizations, pharmacy benefit management
companies, and government programs such as Medicare and Medicaid;
coverage and reimbursement determinations by such payers and new
policies and procedures adopted by such payers; competing drugs and
product candidates that may be superior to, or more cost effective
than, Regeneron's Products and Regeneron's Product Candidates; the
extent to which the results from the research and development
programs conducted by Regeneron and/or its collaborators may be
replicated in other studies and/or lead to advancement of product
candidates to clinical trials, therapeutic applications, or
regulatory approval; unanticipated expenses; the costs of
developing, producing, and selling products; the ability of
Regeneron to meet any of its financial projections or guidance and
changes to the assumptions underlying those projections or
guidance; the potential for any license, collaboration, or supply
agreement, including Regeneron's agreements with Sanofi, Bayer, and
Teva Pharmaceutical Industries Ltd. (or their respective affiliated
companies, as applicable), to be cancelled or terminated; and risks
associated with intellectual property of other parties and pending
or future litigation relating thereto (including without limitation
the patent litigation and other related proceedings relating to
EYLEA® (aflibercept) Injection, Dupixent®
(dupilumab), Praluent® (alirocumab), and
REGEN-COV® (casirivimab and imdevimab)), other
litigation and other proceedings and government investigations
relating to the Company and/or its operations, the ultimate outcome
of any such proceedings and investigations, and the impact any of
the foregoing may have on Regeneron's business, prospects,
operating results, and financial condition. A more complete
description of these and other material risks can be found in
Regeneron's filings with the U.S. Securities and Exchange
Commission, including its Form 10-K for the year ended December 31, 2020 and its Form 10-Q for the
quarterly period ended September 30,
2021. Any forward-looking statements are made based on
management's current beliefs and judgment, and the reader is
cautioned not to rely on any forward-looking statements made by
Regeneron. Regeneron does not undertake any obligation to update
(publicly or otherwise) any forward-looking statement, including
without limitation any financial projection or guidance, whether as
a result of new information, future events, or otherwise.
Regeneron uses its media and investor relations website and
social media outlets to publish important information about the
Company, including information that may be deemed material to
investors. Financial and other information about Regeneron is
routinely posted and is accessible on Regeneron's media and
investor relations website (http://newsroom.regeneron.com) and its
Twitter feed (http://twitter.com/regeneron).
Contacts:
Media
Relations
Taylor
Ramsey
Tel: +1
914-409-2381
taylor.ramsey@regeneron.com
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Relations
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Tosic
Tel: +1
914-847-5443
vesna.tosic@regeneron.com
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SOURCE Regeneron Pharmaceuticals, Inc.