Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced
that the primary endpoint analysis from the pivotal trial
(LINKER-MM1) investigating linvoseltamab demonstrated high rates of
deep and durable responses in patients with relapsed/refractory
(R/R) multiple myeloma (MM). These Phase 1/2 results are planned to
be submitted to regulatory authorities, including to the U.S. Food
and Drug Administration (FDA) this year. Linvoseltamab is an
investigational BCMAxCD3 bispecific antibody designed to bridge
B-cell maturation antigen (BCMA) on multiple myeloma cells with
CD3-expressing T cells to facilitate T-cell activation and
cancer-cell killing.
“Multiple myeloma remains an incurable disease, in which
patients endure cycles of relapse and remission, resulting in a
critical need for innovative medicines,” said L. Andres
Sirulnik, M.D., Ph.D., Senior Vice President, Translational and
Clinical Sciences, Hematology at Regeneron. “With longer follow-up
data on linvoseltamab, we’re seeing deep and durable responses with
a complete response rate nearing 50% in a difficult-to-treat
patient population who had received a median of 5 prior lines of
therapy. Furthermore, in our trial, the regimen had a short
monitoring time and a convenient, response-adapted administration
schedule that enabled deep responders to go from every two-week to
every four-week dosing. This regimen saved time for clinicians and
patients, underscoring the potential for linvoseltamab as a
patient-centric option in relapsed/refractory multiple
myeloma.”
At a median duration of follow-up of 11 months, an objective
response rate of 71% as assessed by an independent review
committee, with 46% achieving a complete response or better, was
observed in patients treated with linvoseltamab 200 mg in the Phase
1/2 trial (n=117). After a minimum of 24 weeks of therapy, patients
who achieved a very good partial response (VGPR) or better shifted
from every two-week to every four-week dosing. These results build
on an earlier data cut, with 8 months of median follow-up, that
will be presented at the 65th American Society of
Hematology (ASH) Annual Meeting and Exposition from December 9
to 12 in San Diego, CA.
Among this group of patients, 27% of patients were over 75 years
old, 16% had extramedullary plasmacytomas, 23% had bone marrow
plasma cells ≥50%, and 39% had high-risk cytogenetics –
representing a patient population with a high disease burden and
typically poor prognosis. Additionally, 17% were Black or African
American, mirroring rates that are representative of MM in the
U.S.
Based on the latest data cut, all patients treated with 200 mg
experienced an adverse event (AE), including 85% who experienced
Grade ≥3 adverse events (AE). The most commonly occurring AE was
cytokine release syndrome (CRS; 46%). Of the CRS cases, the
majority (35%) were Grade 1, 10% were Grade 2 and there was one
case (1%) of Grade 3 CRS. Adjudicated immune effector
cell-associated neurotoxicity syndrome (ICANS) events occurred in 9
patients (8% all Grades); Grade 3 ICANS occurred in 3 patients, and
no cases of ≥Grade 4 cases. All grade infections were observed in
73% of patients; 34% were Grade 3 or 4. Deaths due to
treatment-emergent AEs on-treatment or within 30 days post last
dose occurred in 14 patients (12%), of which 11 (9%) were due to
infections.
The development program investigating linvoseltamab, including
in earlier stages of the disease is underway. In the U.S.,
linvoseltamab has been granted Fast Track Designation for multiple
myeloma by the FDA. Linvoseltamab is currently under clinical
development, and its safety and efficacy have not been fully
evaluated by any regulatory authority.
Investor Webcast InformationRegeneron will host
a conference call and simultaneous webcast to share updates on the
company’s hematology portfolio on Thursday, December
14 at 8:30 AM ET. 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. To participate
via telephone, please register in advance at this link.
Upon registration, all telephone participants will receive a
confirmation email detailing how to join the conference call,
including the dial-in number along with a unique passcode and
registrant ID that can be used to access the call. A replay of the
conference call and webcast will be archived on the company's
website for at least 30 days.
About the Phase 1/2 TrialThe ongoing,
open-label, multicenter Phase 1/2 dose-escalation and
dose-expansion trial is investigating linvoseltamab in patients
with R/R MM. Among the 282 patients enrolled, all have received at
least three prior lines of therapy or are triple refractory.
Patients were administered linvoseltamab utilizing a step-up dosing
regimen that was designed to help mitigate CRS.
The Phase 1 intravenous dose-escalation portion of the trial,
which is now complete, primarily assessed safety, tolerability and
dose-limiting toxicities across nine dose levels of linvoseltamab
exploring different administration regimens. The Phase 2 dose
expansion portion of the trial (LINKER-MM1) is further assessing
the safety and anti-tumor activity of linvoseltamab, with a primary
objective of ORR. Key secondary objectives include duration of
response, PFS, rate of minimal residual disease negative status and
overall survival.
About Multiple MyelomaMultiple myeloma is the
second most common blood cancer. Globally, there are over 176,000
new cases diagnosed annually and an estimated 35,000 people were
diagnosed in the U.S. 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.
About Regeneron in HematologyAt Regeneron,
we’re applying more than three decades of biology expertise with
our proprietary VelociSuite® technologies to develop
medicines for patients with diverse blood cancers and rare blood
disorders.
Our blood cancer research is focused on bispecific antibodies
that are being investigated 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 and gene-knockout technologies, and investigational
RNA-approaches focused on depleting abnormal proteins or blocking
disease-causing cellular signaling.
If you are interested in learning more about our clinical
trials, please contact us (clinicaltrials@regeneron.com or
844-734-6643) or visit our clinical trials website.
About RegeneronRegeneron is a leading
biotechnology company that invents, develops and commercializes
life-transforming medicines for people with serious diseases.
Founded and led for 35 years by physician-scientists, our unique
ability to repeatedly and consistently translate science into
medicine has led to numerous FDA-approved treatments and product
candidates in development, almost all of which were homegrown in
our laboratories. Regeneron’s medicines and pipeline are designed
to help patients with eye diseases, allergic and inflammatory
diseases, cancer, cardiovascular and metabolic diseases,
hematologic conditions, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug
development process through its 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 Regeneron, please visit
www.regeneron.com or follow Regeneron on LinkedIn.
Forward-Looking Statements and Use of Digital
MediaThis 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 nature, timing, and
possible success and therapeutic applications of products marketed
or otherwise commercialized by Regeneron and/or its collaborators
or licensees (collectively, “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 linvoseltamab; 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 linvoseltamab for the treatment of
relapsed/refractory 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 studies discussed or
referenced 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 linvoseltamab); 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 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 or
licensees 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 and Bayer
(or their respective affiliated companies, as applicable) to be
cancelled or terminated; the impact of public health outbreaks,
epidemics, or pandemics (such as the COVID-19 pandemic) on
Regeneron's business; 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 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,
2022 and its Form 10-Q for the quarterly period ended September 30,
2023. 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 (https://investor.regeneron.com/) and
its LinkedIn page
(https://www.linkedin.com/company/regeneron-pharmaceuticals).
Contacts:Media
RelationsTammy Allen Tel: +1
914-306-2698tammy.allen@regeneron.com |
Investor
RelationsVesna TosicTel: +1
914-847-5443vesna.tosic@regeneron.com |
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