First Phase 2 data presented at ASH showed an 82% response
rate in patients with grades 1 to 3a disease, with 75% of the
overall population achieving a complete response
20-month median progression-free survival, with median
overall survival not reached
Data will form the basis of regulatory submissions planned
for 2023
TARRYTOWN, N.Y., Dec. 12,
2022 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc.
(NASDAQ: REGN) today announced positive first data from a cohort of
a pivotal Phase 2 trial evaluating investigational odronextamab in
patients with heavily pre-treated, relapsed/refractory (R/R)
follicular lymphoma (FL) grades 1 to 3a. The data were presented in
an oral session at the 64th American Society of Hematology (ASH)
Annual Meeting and Exposition in New
Orleans, LA, and follow the first Phase 2 results for
odronextamab in R/R diffuse large B-cell lymphoma (DLBCL) from the
same trial that were presented yesterday. The results 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 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.
"There is high unmet need for follicular lymphoma treatments
that can improve tumor control and extend survival, given that
there is no cure for this cancer and patients will experience
multiple relapses," said Tae Min
Kim, M.D., Ph.D., Department of Internal Medicine, Seoul
National University Hospital in
Seoul, South Korea, and a trial
investigator. "These positive pivotal Phase 2 results investigating
odronextamab in heavily pre-treated, relapsed/refractory follicular
lymphoma patients showed deep and durable response – confirming
earlier findings in this program – with the highest complete
response rates seen in this patient population to date. We look
forward to seeing the data continue to mature."
At ASH, efficacy in R/R FL was presented from 121 patients
enrolled in a Phase 2 trial cohort (median follow-up: 22 months,
range: 3-33 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 80 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:
- 82% objective response rate (ORR), with 75% achieving a
complete response (CR). The median duration of complete
response (mDOCR) was 20.5 months (95% confidence interval [CI]: 17
months to not evaluable [NE]).
- Median progression-free survival was 20 months
(PFS; 95% CI: 15 months to NE).
- Median overall survival (OS) not reached (95% CI: NE to
NE).
Among 131 patients assessed for safety, adverse events (AE)
occurred in all patients, with 78% being ≥Grade 3. The most common
AEs occurring in ≥20% of patients were CRS (56.5%), neutropenia
(40%), pyrexia (31%), anemia (30%), infusion-related reaction
(29%), arthralgia (21%), diarrhea (21%) and thrombocytopenia (20%).
Discontinuations due to an AE occurred in 11.5% of patients, and
there were 3 deaths due to pneumonia, progressive multifocal
leukoencephalopathy and systemic mycosis where the relationship to
odronextamab treatment could not be excluded.
CRS was the most common AE, of which 68% of cases were mild
(Grade 1) and all resolved within a median of 2 days (range: 1-51
days). There were no Grade 4 or 5 CRS cases, and the incidence of
both Grade 2 and Grade 3 was reduced with the modified step-up
regimen when compared to the original regimen (original regimen
n=68 vs. step-up regimen n=63; Grade 2: 18% vs. 11%, Grade 3: 6%
vs. 2%).
Based on these data, the OLYMPIA Phase 3 development program
investigating odronextamab is in the process of being initiated. In
the U.S., odronextamab has been granted Fast Track Designation for
FL by the FDA. In the European Union, Orphan Drug Designation was
granted for FL 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 open-label, multicenter
Phase 2 trial investigating odronextamab in more than 500 patients
across five independent disease-specific cohorts, including FL,
diffuse large B-cell 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, PFS, OS, 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 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 some cases, FL can
transform into DLBCL, at which point it is often treated in the
same way as DLBCL.
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.
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and therapeutic applications of Regeneron's Products and product
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without limitation odronextamab (a CD20xCD3 bispecific antibody);
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and the impact of studies (whether conducted by Regeneron or others
and whether mandated or voluntary), including the studies discussed
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likelihood, timing, and scope of possible regulatory approval and
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treatment of patients with relapsed/refractory ("R/R") follicular
lymphoma or R/R diffuse large B-cell lymphoma; safety issues
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including serious complications or side effects in connection with
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EYLEA® (aflibercept) Injection, Praluent®
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quarterly period ended September 30,
2022. Any forward-looking statements are made based on
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Relations
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