Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the
oral plenary session presentation of positive pivotal data from the
Phase 1/2 LINKER-MM1 trial of linvoseltamab in patients with
relapsed/refractory (R/R) multiple myeloma (MM) at the American
Association for Cancer Research (AACR) Annual Meeting 2024 in San
Diego. Linvoseltamab is an investigational 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.
“The presentation of these pivotal results in an oral plenary
session at AACR recognizes the exciting potential of linvoseltamab
to advance the treatment of multiple myeloma,” said Sundar
Jagannath, M.D., Director of the Multiple Myeloma Center of
Excellence at Tisch Cancer Center at Mount Sinai in New York City
and a trial investigator. “In clinical trials, linvoseltamab
treatment led to responses that occurred early, were durable and
deepened over time – all critical efficacy measures for this
heavily pre-treated patient population. Further, among patients who
had at least 24 weeks of treatment, the majority achieved a very
good partial response, enabling them to transition from every
two-week to every four-week dosing. This is an important
accomplishment that I’ve seen firsthand in my trial patients, and I
eagerly anticipate the FDA decision expected this August.”
With an 11-month median duration of follow up, the linvoseltamab
data among 117 patients presented at AACR reinforce the strength of
previously shared findings and included a:
- 71% objective response rate (ORR), with 46% of
patients achieving a complete response (CR) or better and 62%
achieving a very good partial response (VGPR) or better, as
determined by an independent review committee.
- 1-month median time to response (range:
<1-6 months). In responders, the median time to a VGPR or better
was 3 months (range: <1-13 months) and to a CR or better was 8
months (range: 2-14 months).
- Median duration of response (DoR), median
progression-free survival (PFS) and median overall survival (OS)
were not reached. At 12 months, the estimated probability
of maintaining a response was 78%, being progression free was 69%
and survival was 75%.
- Among patients who had a CR or better and were minimum residual
disease (MRD) evaluable, 93% (25 of 27 patients) were MRD
negative at 10-5.
The trial included a response-adapted regimen that enabled
linvoseltamab patients to shift to every four-week dosing if they
achieved a VGPR or better and completed at least 24 weeks of
therapy. In the dose expansion portion of the trial (n=105), of the
patients who had at least 24 weeks of therapy at data cutoff, 90%
(56 of 62) achieved a VGPR or better and were able to
transition to every four-week dosing. Of the 29 patients who
transitioned to the extended dosing regimen prior to achieving a
CR, 48% (14 of 29) subsequently experienced a deepening of response
to CR or better.
In addition, high ORRs were observed across prespecified
subgroups – including high-risk and high-disease burden populations
– as follows:
- 85% among Black or African American patients (17 of 20
patients)
- 71% among those aged 75 years or older (22 of 31 patients)
- 67% among those with high cytogenetic risk (31 of 46
patients)
- 62% among those with International Staging System stage III
disease (13 of 21 patients)
- 53% among those with extramedullary plasmacytomas (10 of 19
patients)
Cytokine release syndrome (CRS) was the most commonly occurring
treatment-emergent adverse event (TEAE) and was observed in 46% of
patients; 35% were Grade 1, 10% were Grade 2 and one case (1%) was
Grade 3. Adjudicated immune effector cell-associated neurotoxicity
syndrome (ICANS) events of any grade occurred in 8% of patients,
including three cases that were Grade 3 and no cases that were
≥Grade 4. Infections occurred in 73% of patients, with their
frequency and severity decreasing after 6 months; 34% were Grade 3
or 4. The most common Grade 3 or 4 TEAEs (≥20%) were neutropenia
(40%) and anemia (31%). Six deaths occurred on treatment or within
30 days of the last treatment dose due to TEAEs; five were due to
infection, and one was due to renal failure.
Linvoseltamab has been granted Fast Track Designation and was
accepted for Priority Review for the treatment of R/R MM by the
FDA, with a target action date of August 22, 2024. In addition,
linvoseltamab is being reviewed by the EMA. Linvoseltamab is
currently under clinical development, and its safety and efficacy
have not been fully evaluated by any regulatory authority.
The Phase 3 confirmatory trial for linvoseltamab in patients
with R/R MM (LINKER-MM3) is underway.
About Multiple MyelomaAs the second most common
blood cancer, there are over 176,000 new cases of MM diagnosed
globally, and 35,000 cases are diagnosed in the U.S. every year. In
the U.S., there are approximately 8,000 people who have MM that has
progressed after three lines of therapy, and 4,000 whose disease
has progressed after four or more therapies. The disease is
characterized by the proliferation of cancerous plasma cells (MM
cells) that crowd out healthy blood cells in the bone marrow,
infiltrate other tissues and cause potentially life-threatening
organ injury. Despite treatment advances, MM is not curable and
while current treatments are able to slow progression of the
cancer, most patients will ultimately experience cancer progression
and require additional therapies.About the Linvoseltamab
Phase 1/2 Trial and Clinical Development ProgramThe
ongoing, open-label, multicenter Phase 1/2 dose-escalation and
dose-expansion LINKER-MM1 trial is investigating linvoseltamab in
282 enrolled patients with relapsed/refractory MM. The Phase 1
dose-escalation portion of the trial – which is now complete –
primarily assessed safety, tolerability and dose-limiting
toxicities across nine dose levels of linvoseltamab and explored
different administration regimens. The ongoing Phase 2 dose
expansion portion is assessing the safety and anti-tumor activity
of linvoseltamab, with the primary endpoint of ORR. Key secondary
endpoints include DoR, PFS, rate of MRD negative status and OS.
Eligibility in the Phase 2 portion requires patients to have
received at least three prior lines of therapy or have triple-class
refractory MM. Linvoseltamab is administered with an initial
step-up dosing regimen followed by the full 200 mg dose
administered weekly. At week 16, all patients transition to every
two-week dosing. A response-adapted regimen further enables
patients to shift to every four-week dosing if they achieve a VGPR
or better and have completed at least 24 weeks of therapy. The
regimen requires a total of two 24-hour hospitalizations for safety
monitoring.
The broader linvoseltamab clinical development program includes
additional trials in earlier lines of therapy and stages of disease
that are planned or underway. They include a Phase 1/2 trial in
first-line MM, a Phase 2 trial in high-risk smoldering MM, and a
Phase 2 trial in monoclonal gammopathy of undetermined
significance. A Phase 1 trial of linvoseltamab in combination with
a Regeneron CD38xCD28 costimulatory bispecific in MM is also
planned. For more information, visit the Regeneron clinical trials
website, or contact via clinicaltrials@regeneron.com or
844-734-6643.
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 various
combinations 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.
About RegeneronRegeneron is a leading
biotechnology company that invents, develops and commercializes
life-transforming medicines for people with serious diseases.
Founded and led for over 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. Our 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 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 more 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 any potential regulatory approval of
linvoseltamab for the treatment of relapsed/refractory multiple
myeloma (“R/R MM”) by the U.S. Food and Drug Administration (the
“FDA”) (including the timing of enrollment of patients in the Phase
3 confirmatory trial for linvoseltamab in patients with R/R MM
referenced in this press release (the “R/R MM Confirmatory Trial”),
whether any beneficial regulatory designations previously granted
by the FDA and referenced in this press release will positively
impact the timing for potential FDA approval, and whether any such
approval will be obtained by the FDA’s target action date
referenced in this press release) or the European Medicines Agency;
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 (such as the R/R MM
Confirmatory Trial), 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), 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,
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
Relations Tammy
Allen Tel: +1 914-306-2698tammy.allen@regeneron.com |
Investor
RelationsVesna TosicTel: +1
914-847-5443vesna.tosic@regeneron.com |
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