49% objective response rate (ORR) in heavily pre-treated patients who were
naïve to prior CAR-T, with 31% achieving a complete response
(CR)
Even in patients who received prior CAR-T, 48% ORR and 32% CR observed in a dose expansion
cohort from a Phase 1 trial
Data will form the basis of regulatory submissions planned
for 2023
TARRYTOWN, N.Y., Dec. 11,
2022 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc.
(NASDAQ: REGN) today announced positive new and updated data from a
Phase 1 and pivotal Phase 2 trial (ELM-1 and ELM-2) evaluating
investigational odronextamab in patients with relapsed/refractory
(R/R) diffuse large B-cell lymphoma (DLBCL). These included first
data from a Phase 2 cohort of patients naïve to prior CAR-T therapy
(CAR-T naïve), as well as updated data from a dose expansion cohort
of a Phase 1 trial in patients who had progressed on CAR-T therapy
(post-CAR-T). The results were presented in an oral session at the
64th American Society of Hematology (ASH) Annual Meeting and
Exposition in New Orleans, LA, and
will form the basis of planned submissions to regulatory
authorities in 2023, including to the U.S. Food and Drug
Administration (FDA). Odronextamab is an investigational bispecific
antibody designed to bridge CD20 on cancer cells with
CD3-expressing T cells to facilitate local T-cell activation and
cancer-cell killing.
"People with diffuse large B-cell lymphoma face a disease that
often relapses and becomes more aggressive each time it returns,
leaving doctors with a shrinking set of treatment options," said
Won Seog Kim, M.D., Ph.D., Samsung Medical Center and Division of
Hematology-Oncology at Sungkyunkwan University, in Seoul, South Korea, and trial investigator.
"The Phase 1 and pivotal Phase 2 odronextamab data demonstrated
deep and durable responses that were consistent in patients who
progress after CAR-T therapy, which is important as they have
particularly difficult-to-treat disease and no effective treatment
options. Coupled with its overall safety profile, these clinically
important results reinforce the potential of odronextamab to treat
this aggressive blood cancer."
At ASH, efficacy in R/R DLBCL was presented from 130 CAR-T naïve
patients in a Phase 2 cohort (includes those with an opportunity
for assessment at 12 weeks; median follow-up: 21 months, range: 3
to 30 months) and 31 CAR-T experienced patients in a dose expansion
cohort of a Phase 1 trial (median follow-up: 24 months, range: 3 to
38.5 months). All patients had received at least two prior
therapies, including a CD20 antibody and alkylating agent. Patients
were treated with a step-up regimen of odronextamab in the first
cycle to help mitigate the risk of cytokine release syndrome (CRS)
before receiving the full dose of 160 mg. The step-up regimen was
modified part way through the trial to further mitigate CRS.
Results as assessed by independent central review were as
follows:
- Among CAR-T naïve patients, a 49% objective
response rate (ORR), with 31%
achieving a complete response (CR). The median duration of
complete response (mDOCR) was 18 months (95% confidence interval
[CI]: 10 months to not evaluable [NE]).
- Among post-CAR-T patients, a 48% ORR, with 32% achieving a CR. The mDOCR
was not reached (95% CI: 2 months to NE).
Among 140 patients in the Phase 2 cohort assessed for safety,
adverse events (AE) occurred in 99% of patients, with 79% being
≥Grade 3. The most common AEs occurring in ≥20% of patients were
CRS (55%), anemia (42%), pyrexia (39%), neutropenia (28%) and
hypokalemia (20%). Discontinuations due to an AE occurred in 10% of
patients, and there were 5 deaths due to pneumonia (n=3), COVID-19
(n=1) and pseudomonal sepsis (n=1) where the relationship to
odronextamab treatment could not be excluded.
CRS was the most common AE, of which 64% of cases were mild
(Grade 1) and all resolved within a median time of 2 days (range:
1-133 days). There were no Grade 4 or 5 CRS cases, and the
incidence of Grade 2 or higher cases was reduced with the modified
step-up regimen when compared to the original (original regimen
n=67 vs. step-up regimen n=73; Grade 2: 18% vs. 14%, Grade 3: 7.5%
vs. 1%).
Based on these data, the OLYMPIA Phase 3 development program
investigating odronextamab in earlier stages of the disease is in
the process of being initiated. In the U.S., odronextamab has been
granted Fast Track Designation for DLBCL by the FDA. In the
European Union, Orphan Drug Designation was granted for DLBCL by
the European Medicines Agency. Odronextamab 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 Wednesday, 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 Trials
ELM-2 is an ongoing, open-label,
multicenter Phase 2 trial investigating odronextamab in more than
500 patients across five independent disease-specific cohorts,
including DLBCL, follicular lymphoma, mantle cell lymphoma,
marginal zone lymphoma and other subtypes of B-cell non-Hodgkin
lymphoma (B-NHL). The primary endpoint is ORR according to the Lugano Classification,
and secondary endpoints include CR, progression free survival,
overall survival, duration of response, disease control rate,
safety and quality of life.
ELM-1 is an ongoing, open-label, multicenter Phase 1 trial to
investigate the safety and tolerability of odronextamab in patients
with CD20+ B-cell malignancies previously treated with
CD20-directed antibody therapy. Subcutaneous administration is
being evaluated in two disease specific cohorts.
About Diffuse Large B-cell Lymphoma (DLBCL)
One of
the most common subtypes of B-NHL, DLBCL is an aggressive form of
B-NHL with up to 50% of patients with advanced stage disease
progressing after first-line treatment (e.g., relapsing or becoming
refractory to treatment). For patients with relapsed/refractory
DLBCL, treatment options are limited and prognosis is poor.
About Regeneron in Hematology
At 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, as well as
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 Regeneron
Regeneron is a leading biotechnology
company that invents, develops and commercializes life-transforming
medicines for people with serious diseases. Founded and led for
nearly 35 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 more information, please visit www.Regeneron.com or follow
@Regeneron on Twitter.
Forward-Looking Statements and Use of Digital
Media
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statements that involve risks and uncertainties relating to future
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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,"
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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
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programs, Regeneron's ability to manage its supply chain, net
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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
odronextamab (a CD20xCD3 bispecific antibody); 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
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 patients with relapsed/refractory diffuse large B-cell
lymphoma; 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
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by regulatory and administrative governmental authorities which may
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coverage and reimbursement determinations by such payers and new
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extent to which the results from the research and development
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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, 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
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in Regeneron's filings with the U.S. Securities and Exchange
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quarterly period ended September 30,
2022. 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.
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Contacts:
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Relations
Tammy
Allen
tammy.allen@regeneron.com
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Investor
Relations
Mark
Hudson
mark.hudson@regeneron.com
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SOURCE Regeneron Pharmaceuticals, Inc.