TARRYTOWN, N.Y., Dec. 1, 2018 /PRNewswire/ --
100% overall and 80% complete response rate in 10 patients
with relapsed or refractory follicular lymphoma treated with 5 mg
or more of REGN1979
Plan to initiate in 2019 a potentially registrational Phase 2
trial in relapsed or refractory follicular lymphoma
Promising clinical activity also seen in ongoing study in
diffuse large B-cell lymphoma
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today
presented new data for REGN1979 in patients with relapsed or
refractory (R/R) B-cell non-Hodgkin lymphoma (B-NHL), including
promising clinical results in follicular lymphoma (FL) and diffuse
large B-cell lymphoma (DLBCL) which are the two most common types
of NHL. In this Phase 1 proof-of-concept trial, REGN1979
demonstrated an acceptable safety and tolerability profile with no
observed dose-limiting toxicities (DLTs). There were no
clinically-significant neurotoxicities, including no occurence of
seizures or encephalopathy. REGN1979 is a wholly-owned,
investigational, full-length bispecific monoclonal antibody
designed to trigger tumor killing by binding CD3 on immune system
T-cells and CD20 on B-cell malignancies.
In the data presented at the 2018 American Society of Hematology
(ASH) Annual Meeting, heavily pre-treated patients with R/R FL
grades 1 to 3a who received REGN1979 doses of 5 mg to 40 mg,
experienced a 100% overall response rate (ORR) (8 complete
responses [CR] and 2 partial responses [PR]); 90% of responders
maintained a response during treatment. Based on these data,
Regeneron plans to initiate in 2019 a potentially registrational
Phase 2 trial investigating REGN1979 in R/R FL.
REGN1979 also showed encouraging dose-dependent clinical
activity in heavily pre-treated patients with R/R DLBCL. Among
patients receiving doses between 5 mg and 12 mg, the ORR was 18% (2
of 11 patients, including 1 CR and 1 PR). At doses of 18 mg to 40
mg, the ORR increased to 60% (6 of 10 patients, including 2 CR and
4 PR). Regeneron plans to continue dose-escalation in
DLBCL.
"While a high response rate is frequently observed in the
first-line treatment of follicular lymphoma, it is remarkable to
see a 100% response rate in heavily pre-treated relapsed or
refractory follicular lymphoma patients," said Israel Lowy, M.D., Ph.D., Head of Clinical and
Translational Sciences, Oncology at Regeneron. "We plan to initiate
a potentially registrational Phase 2 trial in 2019 investigating
REGN1979 in relapsed or refractory follicular lymphoma, and are
also considering its potential as a first-line treatment for this
disease. Furthermore, we are continuing to dose-escalate in the
more difficult-to-treat DLBCL setting, to see if we can continue to
further improve efficacy. Finally, REGN1979 is being investigated
in combination with Libtayo® (cemiplimab-rwlc) in an
ongoing Phase 1 study, which we believe is the first to combine a
CD20xCD3 bispecific antibody with a PD-1 or PD-L1
inhibitor."
"There have been tremendous recent advances in the field of
immuno-oncology, with new breakthrough therapies including
checkpoint inhibitors and personalized cell-based therapies," said
George D. Yancopoulos, M.D., Ph.D.,
President and Chief Scientific Officer at Regeneron. "Regeneron has
recently launched its first checkpoint inhibitor, Libtayo, for a
serious skin cancer with no previously-approved therapies that were
available. Regeneron is also advancing a broad and deep bispecific
antibody platform – which may offer off-the-shelf alternatives to
cell-based therapies for both solid tumors and hematologic
malignancies. Our bispecific antibody pipeline includes REGN1979
and a MUC16xCD3 antibody for ovarian cancer in clinical
development, and a BCMAxCD3 antibody for multiple myeloma expected
to enter human studies before the end of this year. In 2019, we
expect to start clinical trials of a new class of bispecific
antibodies that engage cellular immunity in novel ways. We believe
that cancer treatment in the future will require precision
medicine-based combinations of these and other approaches and that
Regeneron is well positioned to be a future leader in this exciting
area."
The objectives for this ongoing Phase 1 proof-of-concept trial
are to assess safety, tolerability and efficacy of REGN1979
monotherapy. The data presented at ASH included a total of 68
patients with R/R B-NHL who were treated with REGN1979. These
patients had received a median of three prior therapies, including
an anti-CD20 therapy. As of September
2018, 14 patients had completed treatment, 13 patients
remained on treatment and 41 had discontinued treatment. The most
common reason for treatment discontinuation was progressive disease
(27 patients). Two patients discontinued treatment due to a
treatment-emergent adverse event (TEAE; grade 3 hemolysis and grade
3 fatigue).
In the trial, the most common TEAEs occurring in at least 25% of
patients were pyrexia, chills, cytokine release syndrome (CRS),
fatigue, increased C-reactive protein, anemia, hypotension,
infusion-related reaction (IRR) and nausea. IRR and CRS events were
generally mild to moderate in severity, and neither resulted in
trial discontinuations. Three patients in the trial died due to
adverse events. Of these, one death, in a patient with a tumor
involving the gastric lining who experienced a gastric perforation,
was attributed to REGN1979.
REGN1979 was invented by Regeneron using the company's
proprietary VelocImmune® technology that yields
optimized fully-human antibodies, and Regeneron's 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 was granted orphan drug designation by the U.S. Food
and Drug Administration for the treatment of DLBCL in 2017.
REGN1979, REGN4018 (MUC16xCD3 bispecific antibody) and REGN5458
(BCMAxCD3 bispecific antibody) are currently under clinical
development for B-NHL, ovarian cancer and multiple myeloma,
respectively, and their safety and efficacy have not been evaluated
by any regulatory authority. In addition, the potential use of
REGN1979 in combination with Libtayo 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. In the U.S., Libtayo is currently
approved for the treatment of patients with metastatic CSCC or
locally advanced CSCC who are not candidates for curative surgery
or curative radiation. Regeneron and Sanofi Genzyme, the specialty
care global business unit of Sanofi, market Libtayo jointly in the
U.S.
IMPORTANT SAFETY INFORMATION AND INDICATION FOR U.S.
PATIENTS
What is the most important information I should know about
Libtayo?
Libtayo is a medicine that may treat a type of skin
cancer by working with your immune system. Libtayo can cause your
immune system to attack normal organs and tissues in any area of
your body and can affect the way they work. These problems can
sometimes become severe or life-threatening and can lead to death.
These problems may happen anytime during treatment or even after
your treatment has ended.
Call or see your healthcare provider right away if you
develop any symptoms of the following problems or these symptoms
get worse:
- Lung problems (pneumonitis). Signs and symptoms
of pneumonitis may include new or worsening cough, shortness of
breath, and chest pain.
- Intestinal problems (colitis) that can lead to tears or
holes in your intestine. Signs and symptoms of colitis
may include diarrhea (loose stools) or more frequent bowel
movements than usual; stools that are black, tarry, sticky or that
have blood or mucus; and severe stomach-area (abdomen) pain or
tenderness.
- Liver problems (hepatitis). Signs and symptoms of
hepatitis may include yellowing of your skin or the whites of your
eyes, severe nausea or vomiting, pain on the right side of your
stomach area (abdomen), drowsiness, dark urine (tea colored),
bleeding or bruising more easily than normal, and feeling less
hungry than usual.
- Hormone gland problems (especially the adrenal glands,
pituitary, thyroid and pancreas). Signs and symptoms that your
hormone glands are not working properly may include headaches that
will not go away or unusual headaches, rapid heartbeat, increased
sweating, extreme tiredness, weight gain or weight loss, dizziness
or fainting, feeling more hungry or thirsty than usual, hair loss,
feeling cold, constipation, deeper voice, very low blood pressure,
urinating more often than usual, nausea or vomiting, stomach-area
(abdomen) pain, and changes in mood or behavior, such as decreased
sex drive, irritability, or forgetfulness.
- Kidney problems, including nephritis and kidney failure.
Signs of these problems may include decrease in your amount of
urine, blood in your urine, swelling in your ankles, and loss of
appetite.
- Skin problems. Signs of these problems may include rash,
itching, skin blistering, and painful sores or ulcers in the mouth,
nose, throat, or genital area.
- Problems in other organs. Signs of these problems may
include headache, tiredness or weakness, sleepiness, changes in
heartbeat (such as beating fast, seeming to skip a beat, or a
pounding sensation), confusion, fever, muscle weakness, balance
problems, nausea, vomiting, stiff neck, memory problems, seizures
(encephalitis), swollen lymph nodes, rash or tender lumps on skin,
cough, shortness of breath, vision changes, or eye pain
(sarcoidosis), seeing or hearing things that are not there
(hallucinations), severe muscle weakness, low red blood cells
(anemia), bruises on the skin or bleeding, and changes in
eyesight.
- Rejection of a transplanted organ. Your doctor should
tell you what signs and symptoms you should report and monitor you,
depending on the type of organ transplant that you have had.
- Infusion (IV) reactions that can sometimes be severe
and life-threatening. Signs of these problems may include
chills or shaking, itching or rash, flushing, shortness of breath
or wheezing, dizziness, fever, feeling of passing out, back or neck
pain, and facial swelling.
Getting medical treatment right away may help keep these
problems from becoming more serious.
Your healthcare provider will check you for these problems
during your treatment with Libtayo. Your healthcare provider may
treat you with corticosteroid or hormone replacement medicines.
Your healthcare provider may delay or completely stop treatment if
you have severe side effects.
Before you receive Libtayo, tell your healthcare
provider about all your medical conditions, including if
you:
- have immune system problems such as Crohn's disease, ulcerative
colitis, or lupus;
- have had an organ transplant;
- have lung or breathing problems;
- have liver or kidney problems;
- have diabetes;
- are pregnant or plan to become pregnant; Libtayo can harm your
unborn baby
Females who are able to become pregnant:
- Your healthcare provider will give you a pregnancy test before
you start treatment.
- You should use an effective method of birth control during your
treatment and for at least 4 months after your last dose of
Libtayo. Talk with your healthcare provider about birth control
methods that you can use during this time.
- Tell your healthcare provider right away if you become pregnant
or think you may be pregnant during treatment with Libtayo.
- are breastfeeding or plan to breastfeed. It is not known
if Libtayo passes into your breast milk. Do not breastfeed during
treatment and for at least 4 months after the last dose of
Libtayo.
Tell your healthcare provider about all the medicines you
take, including prescription and
over-the-counter medicines, vitamins, and herbal supplements.
The most common side effects of Libtayo include tiredness, rash,
and diarrhea. These are not all the possible side effects of
Libtayo. Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088. You may also
report side effects to Regeneron Pharmaceuticals and Sanofi at
1-877-542-8296.
Please see accompanying full Prescribing Information,
including Medication Guide.
What is Libtayo?
Libtayo is a prescription medicine used to treat people with a
type of skin cancer called cutaneous squamous cell carcinoma (CSCC)
that has spread or cannot be cured by surgery or radiation.
It is not known if Libtayo is safe and effective in
children.
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 (as
monotherapy or in combination with Libtayo®
(cemiplimab-rwlc)) 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 REGN4018
(MUC16xCD3 bispecific antibody), REGN5458 (BCMAxCD3 bispecific
antibody), 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 REGN1979) 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 to perform 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 proceedings relating to EYLEA®
(aflibercept) Injection, Dupixent® (dupilumab)
Injection, and Praluent ® (alirocumab) Injection, the
ultimate outcome of any such litigation 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-Q for the quarterly period ended
September 30, 2018. 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
Mark
Hudson
Tel: +1 (914) 847-3482
Mark.Hudson@regeneron.com
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SOURCE Regeneron Pharmaceuticals, Inc.