Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced
positive data for odronextamab in patients with relapsed/refractory
(R/R) follicular lymphoma (FL) from a pivotal Phase 2 trial
(ELM-2). These data – which include updated efficacy, safety and
patient-reported outcomes (PROs) – were presented at the 65th
American Society of Hematology (ASH) Annual Meeting and Exposition
from December 9 to 12 in San Diego, CA. Odronextamab is an
investigational CD20xCD3 bispecific antibody designed to bridge
CD20 on cancer cells with CD3-expressing T cells to facilitate
local T-cell activation and cancer-cell killing.
“The odronextamab data presented at ASH in patients with
relapsed/refractory follicular lymphoma showcase a strong profile
across measures of efficacy, safety and health-related quality of
life,” said Benoît Tessoulin, M.D., Ph.D., Nantes University
Hospital, Nantes; CRCI2NA, Nantes University, Nantes, France, and a
trial investigator. “As clinicians, our focus must remain patients’
wellbeing, along with favorable outcomes. For odronextamab, it is
particularly encouraging to see the unprecedented clinical results
complemented by patient-reported outcomes that show quality of life
and functional measures are maintained overall. These presentations
underscore the potential role of odronextamab as a future medicine
that treats relapsed/refractory follicular lymphoma and may allow
patients to maintain health-related quality of life during the
course of their therapy.”
As shared at ASH, longer-term data from the Phase 2 odronextamab
trial continued to confirm high rates of durable responses in
patients with R/R FL. At a prespecified interim analysis that
occurred when the first 80 patients had ≥12 months of follow-up,
results among 128 patients that were assessed by independent
central review (ICR) demonstrated:
- 80% objective response rate (ORR), with 73% achieving a
complete response (CR).
- Median duration of response (DoR) was 23
months (95% confidence interval [CI]: 17 months to not
estimable [NE]) and median duration of CR was 24
months (95% CI: 18 months to NE) with a 18-month median
duration of follow-up for efficacy evaluable patients (95% CI: 15
to 28 months).
- Median progression-free survival (PFS) in complete
responders was 28 months (95% CI: 20 months to NE) and 21
months for all patients (95% CI: 17 to 28 months).
- Median overall survival (OS) was not reached
(95% CI: 32 months to NE).
- The most common adverse events (AE) occurring in ≥30% of
patients were cytokine release syndrome (CRS; 56%), neutropenia
(48%), pyrexia (36%), anemia (34%), COVID-19 (31%) and
infusion-related reactions (31%).
- In 60 patients that received the recommended step-up regimen,
57% experienced CRS. All cases were resolved with supportive
measures, with a median duration of 2 days (range: 1 to 10 days).
Among these patients, 45% (n=27) had Grade 1 CRS, 10% (n=6) had
Grade 2 CRS, and 2% (n=1) had Grade 3 CRS.
- There was one Grade 2 immune effector cell-associated
neurotoxicity syndrome event reported, which was not associated
with CRS.
As presented during an oral session at ASH, patients with R/R FL
treated with odronextamab in the ELM-2 trial completed three
validated questionnaires aimed at measuring health-related quality
of life (HRQoL), functioning and symptoms. Pre-specified analyses
were conducted across six scales. Overall, patients reported
generally good HRQoL, functioning and low symptom burden at
baseline as assessed across several scales. Key findings through
Week 50 showed:
- Overall maintenance of moderate to high levels of
functioning and HRQoL without detriments to patient-reported
symptoms based on an analysis of changes in PRO scores
from baseline over time, as measured by the European Organization
for Research and Treatment of Cancer Quality of Life Questionnaire
(EORTC QLQ-C30) scores.
- Median time to definitive deterioration in physical
function and lymphoma-specific symptoms was not reached
(per EORTC QLQ-30 and Functional Assessment of Cancer Therapy
Lymphoma subscale, respectively). In an individual patient-level
analysis, more patients reported maintenance or clinically
meaningful improvement in physical functioning and
lymphoma-specific symptoms than deterioration at each
assessment.
Odronextamab is currently under regulatory review for the
treatment of R/R FL and diffuse large B-cell lymphoma (DLBCL) by
the U.S. Food and Drug Administration, with a target action date of
March 31, 2024, as well as by the European Medicines Agency (EMA).
In the U.S., odronextamab has been granted Fast Track
Designation by the FDA. In the European Union, odronextamab
has been granted Orphan Drug Designation by the EMA.
The potential use of odronextamab in R/R FL and R/R DLBCL is
currently under clinical development, and the 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 Odronextamab Clinical ProgramELM-1 is
an ongoing, open-label, multicenter Phase 1 trial to investigate
the safety and tolerability of odronextamab in patients with
CD20-positive B-cell malignancies previously treated with
CD20-directed antibody therapy. The trial includes an expansion
cohort evaluating DLBCL patients who had progressed on CAR-T
therapy.
ELM-2 is an ongoing, open-label, multicenter pivotal Phase 2
trial investigating odronextamab in 375 patients across five
independent disease-specific cohorts, including DLBCL, FL, mantle
cell lymphoma, marginal zone lymphoma and other subtypes of B-cell
non-Hodgkin lymphoma (B-NHL). The primary endpoint of ELM-2 is ORR
according to the Lugano Classification, and secondary endpoints
include CR, PFS, OS, DoR, disease control rate, safety and quality
of life.
Regeneron has initiated a broad Phase 3 development program to
investigate odronextamab in earlier lines of therapy and other
B-NHLs, representing one of the largest clinical programs in
lymphoma.
About Follicular Lymphoma (FL)One of the most
common subtypes of B-NHL, FL is a slow-growing (indolent) form of
B-NHL, with most cases diagnosed in advanced stages. Although
median survival ranges from 8 to 15 years in advanced FL, current
therapeutic options are not curative, and most patients relapse
within five years, regardless of the regimen. In the U.S., it is
estimated that approximately 13,100 people will be diagnosed with
FL in 2023. In some cases, FL can transform into DLBCL, at which
point it is often treated in the same way as DLBCL.
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 (NASDAQ: REGN) 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
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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 odronextamab; 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 odronextamab for the treatment of
relapsed/refractory follicular lymphoma and relapsed/refractory
diffuse large B-cell lymphoma; 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 odronextamab); 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 (such as odronextamab) 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
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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