TARRYTOWN, N.Y., June 14, 2019 /PRNewswire/ --
93% overall response (13 of 14 patients) and 71% complete
response rates (10 of 14 patients) in follicular lymphoma grades 1
to 3a treated with REGN1979 5 mg to 320 mg
57% overall response rate (4 of 7 patients) in diffuse large
B-cell lymphoma (DLBCL) treated with REGN1979 80 mg to 160 mg, all
of which were complete responses; these included 2 complete
responses in 4 patients whose disease had progressed after CAR-T
treatment
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today
announced positive early-stage data for REGN1979 in patients with
relapsed or refractory (R/R) B-cell non-Hodgkin lymphoma (B-NHL).
The emerging data, which includes patients with R/R diffuse large
B-cell lymphoma (DLBCL) who had progressed after CAR-T therapy,
will be presented tomorrow at the 24th Congress of the
European Hematology Association (EHA). REGN1979 is an
investigational bispecific monoclonal antibody and is designed to
trigger tumor killing by binding to both a B-cell tumor protein
(CD20) and an immune system T-cell receptor (CD3).
"We are very encouraged by the continued high response rates
observed with REGN1979 in both relapsed or refractory diffuse
large B-cell lymphoma and follicular lymphoma, cancers with
typically poor outcomes," said Israel
Lowy, M.D., Ph.D., Senior Vice President and Head of
Clinical and Translational Sciences, Oncology at Regeneron. "In
this trial, two patients who failed CAR-T therapy and received
REGN1979 80 mg achieved complete responses; there is currently no
approved therapy for patients who progress on CAR-Ts. Our
potentially registrational Phase 2 program is initiating this month
and will proactively evaluate active REGN1979 doses in indolent and
aggressive non-Hodgkin lymphoma."
Results from patients in the early-stage dose-escalation trial
are included in the EHA presentation; these include data from
fully-monitored patients as of the March
15 cut-off as well as preliminary results from additional
evaluable patients. The primary objective was to assess the safety,
tolerability and dose-limiting toxicities of REGN1979. Secondary
objectives included an evaluation of the pharmacokinetics,
immunogenicity and antitumor activity of REGN1979. In the trial,
there were no dose-limiting toxicities.
As shown in the EHA presentation:
- R/R follicular lymphoma (FL) grades 1 to 3a: the overall
response rate was 93% (13 of 14 patients) in those who received
doses of 5 mg or more, with a complete response rate of 71% (10 of
14 patients).
- R/R DLBCL: 4 of 7 patients receiving doses of 80 mg to
160 mg achieved complete responses, with all responses
ongoing.
-
- In R/R DLBCL patients who had not received prior CAR-T therapy:
2 of 3 achieved a complete response.
- In R/R DLBCL patients whose disease progressed after CD-19
directed CAR-T therapy: 2 of 4 achieved a complete response.
As of the March 2019 data cutoff,
safety was evaluated in 81 patients. The most common
treatment-emergent adverse events (AEs) were pyrexia (83%),
cytokine release syndrome (CRS; 57%), chills (54%), infections and
infestations (49%), increased C-reactive protein (38%), fatigue
(38%), anemia (36%) and thrombocytopenia (30%). Six patients
experienced Grade 3 or higher CRS (7%). The incidence and severity
of CRS declined through optimized pre-medication, even with
REGN1979 dose escalation. Grade 3 or higher AEs that occurred in at
least 10% of patients were anemia (21%), lymphopenia (20%),
neutropenia (17%), infections and infestations (15%),
thrombocytopenia (14%) and hypophosphatemia (11%). Four patients
discontinued due to AEs, which included Grade 3 hemolysis, fatigue,
pneumonia and neck abscess (n=1 each). Fifty-two patients
discontinued, 27 due to disease progression/recurrence, and 10 due
to death. Deaths were caused by progressive disease (n=6, one with
an AE of Grade 5 multi-organ failure) as well as cardiac arrest,
gastric perforation, lung infection and pneumonia (n=1 each).
"REGN1979 is paving the way for a diverse and proprietary new
platform of home-grown bispecific antibodies, which lack mutations
or other foreign sequences and are designed to look and perform
like natural human antibodies," said David M Weinreich, M.D.,
Senior Vice President, Head, Global Clinical Development and
Co-Head, Global Development. "We currently have four different
bispecific antibodies in clinical trials for both solid tumors and
blood cancers and expect to add more by the end of the year. Among
them is our first costimulatory bispecific antibody REGN5678, which
will be investigated in combination with Libtayo in prostate
cancer."
REGN1979 was granted orphan drug designation by the U.S. Food
and Drug Administration (FDA) for the treatment of DLBCL in 2017
and was invented by Regeneron using the company's proprietary
VelocImmune® technology and proprietary
Veloci-Bi™ bispecific platform. Veloci-Bi allows for
the generation of full-length bispecific antibodies similar to
native antibodies that are amenable to production by standard
antibody manufacturing techniques, and likely to have favorable
antibody-like pharmaco-kinetic properties.
REGN1979 and REGN5678 are currently under clinical development
for B-NHL and prostate cancer, respectively, and their safety and
efficacy have not been evaluated by any regulatory authority. In
addition, the potential use of REGN5678 in combination with
Libtayo® (cemiplimab-rwlc) is investigational, and its
safety and efficacy have not been evaluated by any regulatory
authority.
Libtayo is being developed jointly by Regeneron and Sanofi under
a global collaboration agreement. The generic name for Libtayo in
the U.S. is cemiplimab-rwlc, with rwlc as the suffix designated in
accordance with Nonproprietary Naming of Biological Products
Guidance for Industry issued by the FDA.
About the Phase 1 trial
Phase 1, open-label,
dose-escalation trial involves 81
B-NHL patients to date (45 DLBCL, 21 FL grades 1 to 3a, 6
mantle cell lymphoma, 6 marginal zone lymphoma and 3 with other
subtypes of B-NHL) who had received prior treatment with an
anti-CD20 antibody. The trial has a "3 + 3" design, in which
patients are enrolled into groups receiving increasing doses of
REGN1979 to help determine the recommended effective dose for later
stage trials. Following enrollment in their dosing group, patients
initially received REGN1979 weekly for 12 weeks, followed by doses
every-other-week for 12 weeks, and then are followed for a
subsequent 15 months.
About DLBCL and FL
DLBCL and FL are the two most
common subtypes of B-NHL with approximately 18,000 and 14,800 new
cases diagnosed in the U.S. in 2019, respectively.
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 R/R DLBCL, treatment options are limited and the prognosis is
poor.
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 5 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 Pharmaceuticals, Inc.
Regeneron
(NASDAQ: REGN) is a leading biotechnology company that invents
life-transforming medicines for people with serious diseases.
Founded and led for 30 years by physician-scientists, our unique
ability to repeatedly and consistently translate science into
medicine has led to seven FDA-approved treatments and numerous
product candidates in development, 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, neuromuscular
diseases, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug
development process through our proprietary
VelociSuite® technologies, such as
VelocImmune® which produces optimized fully-human
antibodies, and 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 the company, please visit
www.regeneron.com or follow @Regeneron on Twitter.
Regeneron 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 nature, timing, and
possible success and therapeutic applications of Regeneron's
products, product candidates, and research and clinical programs
now underway or planned, including without limitation REGN1979 in
patients with relapsed or refractory B-cell non-Hodgkin lymphoma,
follicular lymphoma, diffuse large B-cell lymphoma, and other
potential indications, as well as REGN5678 (costimulatory
bispecific antibody being investigated in combination with
Libtayo® (cemiplimab-rwlc) Injection in prostate
cancer), and Regeneron's earlier-stage product candidates (such as
Regeneron's other bispecific antibodies); unforeseen safety issues
resulting from the administration of products and product
candidates in patients, including serious complications or side
effects in connection with the use of Regeneron's product
candidates (such as Libtayo, REGN1979, and REGN5678 (each, as
applicable, as monotherapy or
in combination with other products or product candidates)) in clinical trials; the extent to which
the results from the research and development programs conducted by
Regeneron or its collaborators may be replicated in other studies
and lead to therapeutic applications; the likelihood, timing, and
scope of possible regulatory approval and commercial launch of
Regeneron's late-stage product candidates and new indications for
marketed products; ongoing regulatory obligations and oversight
impacting Regeneron's marketed products, research and clinical
programs, and business, including those relating to patient
privacy; 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 product candidates; competing drugs and product
candidates that may be superior to Regeneron's products and product
candidates; uncertainty of market acceptance and commercial success
of Regeneron's products and product candidates and the impact of
studies (whether conducted by Regeneron or others and whether
mandated or voluntary) on the commercial success of Regeneron's
products and product candidates; the ability of Regeneron to
manufacture and manage supply chains for multiple products and
product candidates; the ability of Regeneron's collaborators,
suppliers, or other third parties (as applicable) to perform
manufacturing, filling, finishing, packaging, labeling,
distribution, and other steps related to Regeneron's products and
product candidates; the availability and extent of reimbursement of
the Company'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; 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, Bayer, and Teva
Pharmaceutical Industries Ltd. (or their respective affiliated
companies, as applicable), to be cancelled or terminated without
any further product success; 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, Dupixent® (dupilumab)
Injection, and Praluent® (alirocumab) Injection, the
ultimate outcome of any such proceedings, 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 fiscal year ended December
31, 2018 and its Form 10-Q for the quarterly period ended
March 31, 2019. 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 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).
Regeneron Contacts:
Media Relations
Daren
Kwok
Tel: +1 (914) 847-1328
Daren.Kwok@regeneron.com
Investor Relations
Justin
Holko
Tel: +1 (914) 847-7786
Justin.Holko@regeneron.com
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