As presented at ASH, recommended 200 mg dose of linvoseltamab
demonstrated a 64% response rate, with 45% of responders achieving
a very good partial response or better; responses may further
improve with longer follow-up
Trial enrolled patients with particularly high disease
burden, with 37% having bone marrow plasma cells ≥50% and the
median soluble BCMA being 0.43 mg/L
Data represent initial efficacy results from first 58
patients in ongoing Phase 2 trial, which is now fully enrolled at
the recommended dose
TARRYTOWN, N.Y.,
Dec. 12, 2022
/PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN)
today announced positive initial data from a pivotal Phase 2
expansion cohort evaluating investigational linvoseltamab (formerly
REGN5458) at the 200 mg dose recommended for further development in
patients with heavily pre-treated, relapsed/refractory (R/R)
multiple myeloma. The results were part of a broader presentation
of new and updated data from a Phase 1/2 trial and were shared at
the 64th American Society of Hematology (ASH) Annual Meeting and
Exposition in New Orleans, LA.
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 local T-cell activation
and cancer-cell killing.
"The need for innovative medicines is critical for patients with
multiple myeloma who inevitably face a downward spiral of relapses,
reduced responses to subsequent therapies, and increasingly shorter
remissions," said Naresh Bumma,
M.D., Hematologist and Assistant Professor in the Division of
Hematology at Ohio State University,
and a trial investigator. "At the recommended 200 mg dose in a
pivotal Phase 2 trial, linvoseltamab demonstrated early, deep and
durable responses in patients living with multiple myeloma who had
been on at least three prior therapies, including those with higher
risk and high disease burden. These clinically meaningful outcomes
at 12 weeks reinforce the positive linvoseltamab results seen in
the Phase 1 dose escalation portion, and we look forward to seeing
data from more patients and longer follow-up."
As presented at ASH, out of 252 patients treated in the Phase
1/2 trial, 81% of patients were triple-refractory to existing
therapeutic options, including an immunomodulatory drug, a
proteasome inhibitor and an anti-CD38 antibody.
Additionally, 37% had bone marrow plasma cells ≥50%, and the
median soluble BCMA was 0.43 mg/L, representing a patient
population with a higher disease burden than those enrolled in
similar trials. Of the 87 patients in the 200 mg cohort, 58 were
evaluated for efficacy. With a median follow-up of 3 months (range:
0 to 30 months), efficacy results were as follows:
- 64% objective response rate (ORR), with 45% achieving a
very good partial response or better, as determined by an
independent review committee. Based on earlier results, responses
may increase with longer follow-up.
- Median time to response was <1 month (range:
<1 to 5 months).
- 79% probability of maintaining a response at 6 months
(95% confidence interval: 50% to 92%), per Kaplan-Meier
estimates.
Among the 87 patients treated in the 200 mg cohort assessed for
safety, adverse events (AEs) occurred in 95% of patients, with 66%
being ≥Grade 3. The most common AEs occurring in ≥20% of patients
were cytokine release syndrome (CRS; 37%), fatigue (32%), anemia
(28%), diarrhea, cough, headache (23% each) and neutropenia (20%).
Discontinuations due to an AE occurred in 6% of patients. When CRS
occurred, in 32 out of 87 patients, 23 of those patients
experienced Grade 1, 8 experienced Grade 2, there was 1 transient
Grade 3 case, and none were ≥Grade 4.
Among the overall patient population across different dose
levels (n=252), the median time to first CRS onset was 11 hours
(range: 0-47 hours) and all cases resolved, with a median time to
resolution of 15 hours (range: 0-377 hours). Deaths due to AEs in
the overall population were reported in 14 patients, including
sepsis/bacterial infection (n=6), COVID-19 (n=4) or other causes
(n=4). None of the deaths were considered related to treatment per
the treating physician.
Linvoseltamab 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 Phase 1/2 Trial
The ongoing, open-label, multicenter Phase 1/2 dose-escalation and
dose-expansion trial is investigating linvoseltamab in patients
with R/R multiple myeloma. Among the 252 patients enrolled, all
have received at least three prior lines of therapy or are double
refractory. Patients were administered linvoseltamab via a step-up
dosing strategy designed to mitigate CRS.
The Phase 1 dose-escalation portion of the trial, which is now
complete, primarily assessed safety, tolerability and dose-limiting
toxicities of linvoseltamab and was comprised of 9 dose-levels. The
fully-enrolled Phase 2 dose expansion portion of the trial is
further assessing the safety and anti-tumor activity of
linvoseltamab, with a primary objective of ORR. Key secondary
objectives include duration of response, progression free survival,
rate of minimal residual disease negative status and overall
survival.
About Multiple Myeloma
Multiple myeloma is the second most common blood cancer with
approximately 34,470 and 176,404 new diagnoses in the U.S. and the
world, respectively, in 2022. It is characterized by the
proliferation of cancerous plasma cells (multiple myeloma cells)
that crowd out healthy blood cells in the bone marrow, infiltrate
other tissues and cause potentially life-threatening organ injury.
Multiple myeloma is not curable despite treatment advances, and
while current treatments are able to slow the progression of the
cancer, most patients will ultimately experience cancer progression
and require additional therapies. In addition, patients are at
increased risk of frequent infections, bone problems, reduced
kidney function and anemia.
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
This 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 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
collaborators' ability to continue to conduct research and clinical
programs, Regeneron's ability to manage its supply chain, net
product sales of products marketed or otherwise commercialized by
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
linvoseltamab (a BCMAxCD3 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 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 linvoseltamab for the
treatment of patients with heavily pre-treated, relapsed/refractory
multiple myeloma; safety issues resulting from the administration
of Regeneron's Products and Regeneron's Product Candidates (such as
linvoseltamab) 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 (including those discussed or referenced in this press
release) may be replicated in other studies and/or lead to
advancement of product candidates to clinical trials or therapeutic
applications; the ability of Regeneron to manufacture and manage
supply chains for multiple products and product candidates; 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; 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 or collaboration agreement, including Regeneron's
agreements with Sanofi and Bayer (or their respective affiliated
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
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, 2021 and its Form 10-Q for the
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.
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 (http://newsroom.regeneron.com) and its
Twitter feed (http://twitter.com/regeneron).
Contacts:
Media
Relations
Tammy
Allen
tammy.allen@regeneron.com
|
Investor
Relations
Mark
Hudson
mark.hudson@regeneron.com
|
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SOURCE Regeneron Pharmaceuticals, Inc.