Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced new
and updated data for odronextamab in patients with
relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL).
The data from the pivotal Phase 2 trial (ELM-2) and Phase 1 trial
(ELM-1) were shared in several presentations – including two orals
– 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.
“Diffuse large B-cell lymphoma has a high risk of relapse, which
is why it is so critical to demonstrate continued disease control
over the long term. The totality of the odronextamab data at ASH
reinforces its potential as a promising treatment option for
patients with this aggressive blood cancer,” said Sabarish Ram
Ayyappan, M.D., medical director of hematologic malignancies, City
of Hope Atlanta, and a trial investigator. “The primary analysis
from the pivotal trial of odronextamab demonstrated impressive
response rates, including in certain high-risk subgroups.
Furthermore, these responses were durable and consistent with those
seen in a Phase 1 trial in patients who had previously progressed
on CAR-T therapy, a population with a very poor prognosis.”
As presented in an oral session, the primary Phase 2 analysis
was performed by independent central review (ICR) among 127 DLBCL
patients treated with odronextamab when all had the opportunity for
≥36 weeks of follow-up. Results were as follows:
- 52% objective response rate (ORR),
with 31% achieving a complete response (CR).
- Responses were observed across high-risk
subgroups, including those with International Prognosis
Index (IPI) high-risk scores of 3 to 5, high-grade lymphoma that is
double-hit and triple-hit, and transformed DLBCL.
- Median duration of response (DoR) was
10 months (95% confidence interval [CI]: 5 to 18 months),
with a 30-month median duration of follow-up for efficacy evaluable
patients (95% CI: 20 to 33 months). The median duration of CR was
18 months (95% CI: 10 months to not estimable [NE]).
- The most common adverse events (AE) in ≥30% patients were
cytokine release syndrome (CRS; 55%), pyrexia (43%), anemia (39%)
and neutropenia (31%).
- In 60 patients that received the recommended step-up regimen,
53% experienced CRS. All cases were resolved with supportive
measures, with a median duration of 2 days (range: 1 to 7 days).
Among these patients, 40% (n=24) had Grade 1 CRS, 12% (n=7) had
Grade 2 CRS, and 2% (n=1) had Grade 3 CRS.
- No events of immune effector cell-associated neurotoxicity
syndrome (ICANS) were reported.
An additional analysis from the Phase 1 trial demonstrated
encouraging and durable antitumor activity with odronextamab in
heavily pretreated patients who had progressed after CAR-T therapy.
Median duration of exposure was 11 weeks (range: <1 to 122
weeks) among 46 treated patients. Results among 44
efficacy-evaluable patients, including 73% who were CAR-T
refractory, as assessed by ICR showed:
- 48% ORR, with 30% achieving a CR. Notably, 8
patients converted from a partial response to a CR over the study
period.
- Both median DoR and median duration of CR were not
reached (95% CI: 2 to NE) with a 5-month median duration
of follow-up (95% CI: 3 to 9 months).
- The most common AEs in ≥30% of patients were CRS (52%), anemia,
pyrexia and fatigue (each 34%). All CRS events were resolved, with
a median time to resolution of 2 days (range: 1 to 8 days). Among
these patients, 27% (n=12) had Grade 1 CRS and 25% (n=11) had Grade
2 CRS.
In a separate oral presentation on an exploratory analysis from
the Phase 2 trial, data showed a positive association between
minimal residual disease (MRD) status, as measured by circulating
tumor DNA (ctDNA), and progression-free survival (PFS). Among 70
R/R DLBCL and 65 R/R follicular lymphoma (FL) patients assessed,
nearly all were MRD-positive at baseline. Notably, those who were
MRD-negative at time of the first response assessment (Cycle 4, Day
15) had significantly longer PFS than those who remained
MRD-positive (DLBCL Hazard Ratio [HR]: 0.27, 95% CI: 0.12 to 0.61;
FL HR: 0.26, 95% CI: 0.1 to 0.66).
“Our research is among the first to analyze circulating tumor
DNA in a pivotal trial in relapsed/refractory stages of diffuse
large B-cell lymphoma and follicular lymphoma,” said Jon E.
Arnason, M.D., hematologist and oncologist, Beth Israel Deaconess
Medical Center, and a trial investigator. “These findings
strengthen the body of evidence supporting the importance of
minimal residual disease status as a monitoring tool in the course
of managing patients with lymphoma. As the data for circulating
tumor DNA continues to grow, these insights may help inform future
response-directed treatment paradigms.”
Odronextamab is currently under regulatory review for the
treatment of R/R DLBCL and R/R FL by the U.S. Food and Drug
Administration (FDA), 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 for DLBCL and
FL by the FDA. In the European Union, odronextamab has been granted
Orphan Drug Designation in DLBCL and FL by the EMA.
The potential use of odronextamab in R/R DLBCL and R/R FL 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, overall survival, 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 Diffuse Large B-cell Lymphoma
(DLBCL)DLBCL is one of the most common subtypes of B-NHL.
In the U.S., it is estimated that approximately 31,000 people will
be diagnosed with DLBCL in 2023. Globally, there are an estimated
163,000 DLBCL cases each year. DLBCL is an aggressive cancer 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 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.
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Contacts:Media
RelationsTammy Allen Tel: +1
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