TARRYTOWN, N.Y. and
BRIDGEWATER, N.J., June 4, 2017 /PRNewswire/ --
Oral presentation provides first REGN2810 data in patients
with advanced cutaneous squamous cell carcinoma (CSCC)
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi
today announced positive preliminary results with investigational
REGN2810, a checkpoint inhibitor targeting PD-1 (programmed death
1), in patients with advanced cutaneous squamous cell carcinoma
(CSCC). The data, pooled from two expansion cohorts
of the REGN2810 Phase 1 trial, will be presented today at the 2017
American Society of Clinical Oncology (ASCO) Annual Meeting in
Chicago during an oral
presentation (Abstract #9503). REGN2810 is also being investigated
in EMPOWER-CSCC 1, an ongoing Phase 2 potentially pivotal,
single-arm, open label clinical trial that is currently enrolling
advanced CSCC patients.
Treatment with REGN2810 led to an investigator-assessed overall
response rate (ORR) of 46.2 percent (12 of 26 patients, including 2
complete responses, 9 partial responses and 1 unconfirmed partial
response) and a disease control rate (DCR) of 69.2 percent (18 of
26 patients, including 12 ORR and 6 stable disease). The median
progression free survival and overall survival were not reached at
the data cutoff date with a median follow up of 6.9 months (range:
1.1 to 13.8 months; ongoing). One patient experienced progressive
disease during treatment with REGN2810 after the initial response,
and two patients were not evaluable due to death, which was
considered unrelated to REGN2810. Ten patients remain in response
as of the data cutoff date (range: 8 to 40 weeks duration of
response).
The most common treatment-related adverse event of any grade was
fatigue (23.1 percent). All grade 3 or higher adverse events
occurred once and included arthralgia (3.8 percent), maculopapular
rash (3.8 percent), asthenia (3.8 percent), aspartate
aminotransferase (AST) elevation (3.8 percent) and alanine
aminotransferase (ALT) elevation (3.8 percent).
"Cutaneous squamous cell carcinoma or CSCC is the second
deadliest skin cancer after melanoma, according to the most recent
data available," said Kyriakos P.
Papadopoulos, M.D., Senior Clinical Investigator at South
Texas Accelerated Research Therapeutics (START) and the study
presenter. "There are limited treatments and no established
standards of care for advanced stages of this disease. CSCC has one
of the highest mutation rates reported for any cancers, likely
contributing to the study findings, which represent a high
responder rate to a PD-1 antibody in a solid tumor cancer. These
results are promising and suggest the PD-1 pathway is an important
therapeutic target in these patients."
No apparent association between the objective response and level
of PD-L1 (programmed death ligand 1) expression was found. PD-L1
expression by immunohistochemistry (22C3 clone, Dako) was performed
in tumor cells for 21 expansion cohort patients, with 81 percent of
patients (17 of 21) having greater than or equal to 1 percent
positive PD-L1 expression. Additional correlative studies are in
process.
This Phase 1 study was designed with an initial dose-escalation
portion followed by multiple expansion cohorts that were opened to
investigate safety and antitumor activity in specific patient
populations. These results are from 10 patients with distantly
metastatic CSCC who were enrolled in one expansion cohort (Cohort
7) and 16 patients with inoperable (unresectable) locally or
regionally advanced CSCC who were enrolled in a second expansion
cohort (Cohort 8). All expansion cohort patients were treated with
3 mg/kg doses of REGN2810 by intravenous infusion over 30 minutes
every two weeks for up to 48 weeks.
REGN2810 is a human, monoclonal antibody targeting the
checkpoint inhibitor PD-1 and is being jointly developed by
Regeneron and Sanofi under a global collaboration agreement.
REGN2810 is currently being explored as a monotherapy for multiple
cancers – including cutaneous squamous cell carcinoma (CSCC), basal
cell carcinoma (BCC) and non-small cell lung cancer (NSCLC) – as
well as in combination with REGN3767, another investigational
immunotherapy targeting the checkpoint inhibitor LAG-3
(lymphocyte-activation gene 3).
REGN2810 and REGN3767 are currently under clinical development,
and their safety and efficacy have not been fully evaluated by any
regulatory authority.
About CSCC
CSCC is the second most common type of skin
cancer in the United States.
Although CSCC has a good prognosis when caught early and removed
with surgery, it can prove especially aggressive when it progresses
to advanced stages. Patients at this stage can be disfigured due to
multiple surgeries to remove skin-surface tumors on the head, neck
and other parts of the body. CSCC is responsible for the most
deaths among non-melanoma skin cancer patients.
About Sanofi
Sanofi, a global healthcare leader,
discovers, develops and distributes therapeutic solutions focused
on patients' needs. Sanofi is organized into five global business
units: Diabetes and Cardiovascular, General Medicines and Emerging
Markets, Sanofi Genzyme, Sanofi Pasteur and Consumer Healthcare.
Sanofi is listed in Paris
(EURONEXT: SAN) and in New York
(NYSE: SNY).
About Regeneron Pharmaceuticals, Inc.
Regeneron
(NASDAQ: REGN) is a leading science-based biopharmaceutical company
that discovers, invents, develops, manufactures and commercializes
medicines for the treatment of serious medical conditions. All
Regeneron commercialized medicines were discovered and developed by
our own scientists, including therapies for eye diseases, high LDL
cholesterol, atopic dermatitis, rheumatoid arthritis, and a rare
inflammatory condition. Regeneron also has product candidates in
development in other areas of high unmet medical need, including
asthma, pain, cancer and infectious diseases.
Regeneron invented the leading VelociSuite® technologies, which
are a suite of complementary genetics-based technologies that
accelerate, improve and disrupt the traditional drug discovery and
development process and established the Regeneron Genetics Center,
one of the largest genetic sequencing efforts in the world. For
additional information about the company, please visit
www.regeneron.com or follow @Regeneron on Twitter.
Sanofi Forward-Looking Statements
This press
release contains forward-looking statements as defined in the
Private Securities Litigation Reform Act of 1995, as amended.
Forward-looking statements are statements that are not historical
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underlying assumptions, statements regarding plans, objectives,
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for the year ended December 31, 2016.
Other than as required by applicable law, Sanofi does not undertake
any obligation to update or revise any forward-looking information
or statements.
Regeneron Forward-Looking Statements and Use of Digital
Media
This news 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 Regeneron's
immuno-oncology program, REGN2810 (an investigational antibody
targeting the checkpoint inhibitor PD-1 (programmed death 1) that
is being jointly developed by Regeneron and Sanofi), REGN3767 (an
investigational antibody targeting the checkpoint inhibitor LAG-3
(lymphocyte-activation gene 3) that is being jointly
developed by Regeneron and Sanofi), and the combination therapy
involving REGN2810 and REGN3767 (the "PD-1/LAG-3 Combination
Therapy"); 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 in clinical trials, such
as REGN2810, REGN3767, and the PD-1/LAG-3 Combination Therapy;
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; 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 (such as the
clinical programs referenced in this news release), and business,
including those relating to patient privacy; 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's collaborators, suppliers, or other third parties to
perform filling, finishing, packaging, labelling, distribution, and
other steps related to Regeneron's products and product candidates;
coverage and reimbursement determinations by third-party payers,
including Medicare and Medicaid; the ability of Regeneron to
manufacture and manage supply chains for multiple products and
product candidates; unanticipated expenses; the costs of
developing, producing, and selling products; the ability of
Regeneron to meet any of its sales or other 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 HealthCare LLC, 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 relating to
Praluent® (alirocumab) Injection, the permanent
injunction granted by the United States District Court for the
District of Delaware that, if
upheld on appeal, would prohibit Regeneron and Sanofi from
marketing, selling, or commercially manufacturing Praluent in
the United States, the outcome of
any appeals regarding such injunction, the ultimate outcome of such
litigation, 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 United States
Securities and Exchange Commission, including its Form 10-K for the
year ended December 31, 2016 and its
Form 10-Q for the quarterly period ended March 31, 2017. 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
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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.
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(http://newsroom.regeneron.com) and its
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(http://twitter.com/regeneron).
Contacts
Sanofi:
Media
Relations
Ashleigh
Koss
Tel: +1 (908)
981-8745
ashleigh.koss@sanofi.com
Investor
Relations
George
Grofik
Tel: +33 (0)1 53 77
45 45
ir@sanofi.com
|
Contacts
Regeneron:
Media
Relations
Daren Kwok
Tel: +1 (914)
847-1328
daren.kwok@regeneron.com
Investor
Relations
Manisha Narasimhan,
Ph.D.
Tel: +1 (914)
847-5126
manisha.narasimhan@regeneron.com
|
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SOURCE Regeneron Pharmaceuticals, Inc.