Sanofi and
Regeneron announce positive topline pivotal results for PD-1
antibody cemiplimab in advanced cutaneous squamous cell
carcinoma High and durable response rate in disease without any
FDA-approved therapies Cemiplimab rolling BLA submission initiated
per FDA Breakthrough Therapy Designation, with completed submission
expected in Q1 2018 Paris, France & Tarrytown,
N.Y. - December 13, 2017 - Sanofi and Regeneron
Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive
topline results from a pivotal Phase 2 clinical study of cemiplimab
in 82 patients with advanced cutaneous squamous cell carcinoma
(CSCC), the second deadliest skin cancer after melanoma.[i],[ii]
Cemiplimab, an investigational human antibody targeting PD-1
(programmed cell death protein 1), demonstrated an overall response
rate (ORR) of 46.3%, as determined by independent review. The
median duration of response had not yet been reached at the data
cut-off point (32 of 38 responses are ongoing). At the time of this
analysis all patients had a minimum of 6 months of follow up. The
safety profile in this study was generally consistent with approved
anti-PD-1 agents. These pivotal data will form the basis of a
rolling Biologics License Application (BLA) submission to the U.S.
Food and Drug Administration (FDA), which has been initiated and is
expected to be completed in the first quarter of 2018. A rolling
BLA submission allows for portions of the regulatory application to
be submitted to the FDA as they are completed.[iii] A submission to
the European Medicines Agency (EMA) is also expected to be
completed in the first quarter of 2018. These data confirm the
positive Phase 1 clinical trial expansion cohort results reported
at ASCO 2017, which led to a Breakthrough Therapy Designation for
cemiplimab in advanced CSCC in September 2017. "EMPOWER-CSCC 1 was
initiated in 2016 and has enrolled rapidly, underscoring the
serious unmet need in advanced CSCC," said Elias Zerhouni, M.D.,
President, Global R&D, Sanofi. "We look forward to working with
regulatory agencies globally to bring this important therapy to
advanced CSCC patients as quickly as possible. We continue to
rapidly advance a broad development program to evaluate cemiplimab
both as monotherapy and combination across a number of solid tumor
and blood cancers." The efficacy data reported today include
results from 82 patients in the Phase 2 EMPOWER-CSCC 1 study.
Approximately two-thirds of patients had progressed after prior
systemic chemotherapy or radiation. "For patients with CSCC
that cannot be cured by surgery or radiation, there are no
FDA-approved treatment options, and advanced CSCC is responsible
for 3,900 to 8,800 deaths per year in the U.S.,[iv]" said Israel
Lowy, MD, PhD, Vice President of Global Clinical Development and
Head of Translational Science and Clinical Oncology, Regeneron.
"This is the largest prospective study ever conducted in this
disease, and we are pleased that many people were able to achieve
deep and durable responses with cemiplimab monotherapy. The high
and durable response rates seen in this study are particularly
notable given that the study enrolled patients regardless of
biomarker status." EMPOWER-CSCC 1 is a single-arm,
open-label clinical trial and remains active. Enrollment is
complete in the study arm of patients with metastatic CSCC
receiving a 3 mg/kg dose of cemiplimab every two weeks. Enrollment
continues in the remaining two study arms of patients with
metastatic CSCC receiving a 350 mg flat dose of cemiplimab every
three weeks and patients with locally advanced and unresectable
CSCC receiving a 3 mg/kg dose of cemiplimab every two weeks.
Updated results from both the EMPOWER-CSCC 1 Phase 2 trial and the
Phase 1 clinical trial will be submitted for presentation at a 2018
medical congress. Cemiplimab is being jointly developed by
Regeneron and Sanofi under a global collaboration agreement.
Cemiplimab is currently under clinical development, and its safety
and efficacy has not been fully evaluated by any regulatory
authority. About Cutaneous Squamous Cell Carcinoma
(CSCC)CSCC is the second most common type of skin cancer in the
United States. Although CSCC has a good prognosis when caught
early, it can prove especially difficult to treat when it
progresses to advanced stages.[v] Patients at this stage can be
disfigured due to multiple surgeries to remove CSCC tumors on the
head, neck and other parts of the body.[vi] CSCC is the second
deadliest skin cancer after melanoma[vii],[viii] and is responsible
for the most deaths among non-melanoma skin cancer patients.6
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regarding whether and when to approve any drug, device or
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and the ultimate outcome of such litigation, trends in
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Regeneron Forward-Looking Statements and Use of Digital
MediaThis 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 cemiplimab
(REGN2810) for the treatment of patients with advanced cutaneous
squamous cell carcinoma (CSCC) or other potential indications;
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
cemiplimab; 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, such as cemiplimab for the treatment of patients
with advanced CSCC and other potential indications (including the
impact (if any) of the Breakthrough Therapy designation status
granted to cemiplimab for the treatment of patients with advanced
CSCC by the U.S. Food and Drug Administration); the extent to which
the results from the research and development programs conducted by
Regeneron or its collaborators may be replicated in later studies
and lead to therapeutic applications; ongoing regulatory
obligations and oversight impacting Regeneron's marketed products,
research and clinical programs (such as the clinical programs
relating to cemiplimab 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
proceedings relating to 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 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 September 30, 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
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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
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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
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Twitter feed (http://twitter.com/regeneron). |