Sanofi: Libtayo® (cemiplimab) approved by the European Commission
as the first immunotherapy indicated for patients with advanced
basal cell carcinoma
Libtayo®
(cemiplimab)
approved by
the European Commission
as the first immunotherapy indicated for
patients with advanced basal cell carcinoma
- Approval based on data from the largest trial to date in
patients with advanced basal cell carcinoma previously treated with
a hedgehog pathway inhibitor
- Libtayo now approved by the European Commission for three
advanced cancers
PARIS
and TARRYTOWN,
NY –
June 25,
2021 – The European Commission (EC) has
approved Sanofi and Regeneron’s PD-1 inhibitor Libtayo®
(cemiplimab) to treat adults with locally advanced or metastatic
basal cell carcinoma (BCC) who have progressed on or are intolerant
to a hedgehog pathway inhibitor (HHI).
BCC is the most common type of skin cancer
worldwide, representing up to 80% of non-melanoma skin cancers, and
incidence is increasing across many European countries. While the
large majority of BCCs are caught early and easily cured with
surgery and/or radiation, a small proportion of cases can develop
into advanced BCC and penetrate deeper into surrounding tissues
(locally advanced) or spread to other parts of the body
(metastatic), becoming more difficult to treat.
“Since its launch in Europe just two years ago,
Libtayo has redefined the standard of care for advanced CSCC and
has the potential to do the same in advanced BCC,” said Peter C.
Adamson, M.D., Global Development Head, Oncology at Sanofi.
“Together with Regeneron, we’re committed to addressing gaps in the
treatment of advanced forms of non-melanoma skin cancer.”
Libtayo is now approved for three advanced
cancers in the European Union, following the EC’s concurrent
approval of Libtayo for the first-line treatment of adult patients
with advanced non-small cell lung cancer (NSCLC) whose tumor cells
have ≥50% PD-L1 expression and no EGFR, ALK or ROS1 aberrations. In
2019, Libtayo was approved by the EC as the first treatment for
adults with metastatic or locally advanced cutaneous squamous cell
carcinoma (CSCC) who are not candidates for curative surgery or
curative radiation. Across all of its approved indications, Libtayo
had a generally consistent safety profile. Immune-mediated adverse
reactions, which may be severe or fatal, can occur in any organ
system or tissue during or after treatment with Libtayo.
The EC approval in BCC is based on data from the
largest prospective clinical trial (n=119) in patients with
advanced BCC previously treated with an HHI to date.
Libtayo-treated patients with locally advanced BCC experienced an
objective response rate (ORR) of 32% (95% confidence interval [CI]:
22-43) (25% partial response, 7% complete response) by independent
central review. Libtayo-treated patients with metastatic BCC
demonstrated an ORR of 29% (95% CI: 15-46) (26% partial response,
3% complete response) by investigator assessment. In addition,
approximately 90% of patients across both groups had a duration of
response (DOR) of 6 months or longer per Kaplan Meier estimates,
and the median DOR has not been reached for either group. Median
duration of follow-up was 16 months for locally advanced BCC and 9
months for metastatic BCC.
Safety was assessed in 816 patients across all
four Libtayo monotherapy pivotal trials in its approved
indications. Adverse events were serious in 30% of patients
and led to permanent discontinuation in 8% of patients.
Immune-related adverse reactions occurred in 22% of patients
and led to permanent discontinuation in 4% of patients. The most
common immune-related adverse reactions were hypothyroidism (8%),
hyperthyroidism (3%), pneumonitis (3%), hepatitis (2%), colitis
(2%) and immune-related skin adverse reactions (2%).
“Libtayo is the first immunotherapy to show a
clinical benefit in patients with advanced BCC after HHI therapy in
a pivotal trial, and with this first-in-class approval has the
potential to transform treatment for patients in Europe whose
cancer has progressed despite HHI treatment,” said Israel Lowy,
M.D., Ph.D., Senior Vice President, Translational and Clinical
Sciences, Oncology at Regeneron. “We look forward to continuing to
investigate this medicine in additional settings, with the goal of
helping more patients with difficult-to-treat cancers around the
world.”
About the Phase 2 Trial in Advanced
BCC
The EC approval was based on data from an
ongoing open-label, multi-center, non-randomized Phase 2 trial of
patients with unresectable locally advanced BCC or metastatic BCC
(nodal or distant). Patients in both cohorts had either progressed
on HHI therapy, had not had an objective response after 9 months on
HHI therapy, or were intolerant of prior HHI therapy. The primary
efficacy endpoint was confirmed ORR, and a key secondary endpoint
was DOR, assessed by independent central review.
About
Libtayo
Libtayo is a fully human monoclonal antibody
targeting the immune checkpoint receptor PD-1 on T-cells. By
binding to PD-1, Libtayo has been shown to block cancer cells from
using the PD-1 pathway to suppress T-cell activation.
The recommended dose of Libtayo is 350 mg
administered as an intravenous infusion over 30 minutes every three
weeks, until disease progression or unacceptable toxicity. Libtayo
is available as a single-dose 350 mg vial. No PD-L1 or tumor
mutational burden (TMB) testing is required before starting
treatment with Libtayo for advanced BCC.
The extensive clinical program for Libtayo is
focused on difficult-to-treat cancers. Current clinical development
programs include Libtayo in combination with chemotherapy for
advanced NSCLC irrespective of PD-L1 expression and Libtayo
monotherapy for advanced cervical cancer. Libtayo is also being
investigated in combination with either conventional or novel
therapeutic approaches for other solid tumors and blood
cancers. These potential uses are investigational, and their
safety and efficacy have not been evaluated by any regulatory
authority.
The generic name for Libtayo in its
approved U.S. indications is cemiplimab-rwlc, with rwlc
as the suffix designated in accordance with Nonproprietary Naming
of Biological Products Guidance for Industry issued by the U.S.
Food and Drug Administration (FDA). Libtayo is being jointly
developed by Regeneron and Sanofi under a global collaboration
agreement.
About Regeneron
Regeneron (NASDAQ: REGN) is a leading
biotechnology company that invents life-transforming medicines for
people with serious diseases. Founded and led for over 30 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 additional information about the company,
please visit www.regeneron.com or follow @Regeneron on Twitter.
About Sanofi Sanofi is dedicated to
supporting people through their health challenges. We are a global
biopharmaceutical company focused on human health. We prevent
illness with vaccines, provide innovative treatments to fight pain
and ease suffering. We stand by the few who suffer from rare
diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is
transforming scientific innovation into healthcare solutions around
the globe. |
|
Media Relations Contacts Ashleigh
KossTel: +1 (908) 205-2572ashleigh.koss@sanofi.com
|
Investor Relations - Paris Eva
Schaefer-Jansen Arnaud Delepine Natalie Pham
Investor Relations – North America Felix
Lauscher Fara Berkowitz Suzanne Greco
IR main line: Tel.: +33 (0)1 53 77 45
45 investor.relations@sanofi.com https://www.sanofi.com/en/investors/contact |
Regeneron Media Relations Contact Taylor
Ramsey Tel: +1
914-847-5459 taylor.ramsey@regeneron.com |
Regeneron Investor Relations
Contacts Vesna Tosic Tel: +1
914-847-5443 vesna.tosic@regeneron.com |
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
facts. These statements include projections and estimates regarding
the marketing and other potential of the product, or regarding
potential future revenues from the product. Forward-looking
statements are generally identified by the words “expects”,
“anticipates”, “believes”, “intends”, “estimates”, “plans” and
similar expressions. Although Sanofi’s management believes that the
expectations reflected in such forward-looking statements are
reasonable, investors are cautioned that forward-looking
information and statements are subject to various risks and
uncertainties, many of which are difficult to predict and generally
beyond the control of Sanofi, that could cause actual results and
developments to differ materially from those expressed in, or
implied or projected by, the forward-looking information and
statements. These risks and uncertainties include among other
things, unexpected regulatory actions or delays, or government
regulation generally, that could affect the availability or
commercial potential of the product, the fact that product may not
be commercially successful, the uncertainties inherent in research
and development, including future clinical data and analysis of
existing clinical data relating to the product, including post
marketing, unexpected safety, quality or manufacturing issues,
competition in general, risks associated with intellectual property
and any related future litigation and the ultimate outcome of such
litigation, and volatile economic and market conditions, and the
impact that COVID-19 will have on us, our customers, suppliers,
vendors, and other business partners, and the financial condition
of any one of them, as well as on our employees and on the global
economy as a whole. Any material effect of COVID-19 on any of the
foregoing could also adversely impact us. This situation is
changing rapidly and additional impacts may arise of which we are
not currently aware and may exacerbate other previously identified
risks. The risks and uncertainties also include the uncertainties
discussed or identified in the public filings with the SEC and the
AMF made by Sanofi, including those listed under “Risk Factors” and
“Cautionary Statement Regarding Forward-Looking Statements” in
Sanofi’s annual report on Form 20-F for the year ended December 31,
2020. 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 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 (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 (collectively, “Regeneron’s
Product Candidates”) and research and clinical programs now
underway or planned, including without limitation Libtayo®
(cemiplimab) for the treatment of locally advanced or metastatic
basal cell carcinoma; uncertainty of the utilization, market
acceptance, and commercial success of Regeneron's Products (such as
Libtayo) and Regeneron’s Product Candidates and the impact of
studies (whether conducted by Regeneron or others and whether
mandated or voluntary), including the study discussed in this press
release, on any of the foregoing; 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 possible regulatory approval of Libtayo in
combination with chemotherapy for advanced non-small cell lung
cancer irrespective of PD-L1 expression and as monotherapy for
advanced cervical cancer (as well as in combination with either
conventional or novel therapeutic approaches for both solid tumors
and blood cancers); 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
Regeneron’s Product Candidates; the ability of Regeneron to
manufacture and manage supply chains for multiple products and
product candidates; safety issues resulting from the administration
of Regeneron's Products (such as Libtayo) and Regeneron’s Product
Candidates 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, including without limitation Libtayo; 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 may be replicated
in other studies and/or lead to advancement of product candidates
to clinical trials, therapeutic applications, or regulatory
approval; 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, collaboration, or supply 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; 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), 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,
2020 and its Form 10-Q for the quarterly period ended March 31,
2021. 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). |
- 2021_06_25_SANOFI_LIBTAYO_BCC_EC_Approval_PR_EN
Sanofi (BIT:1SAN)
Historical Stock Chart
Von Mär 2024 bis Apr 2024
Sanofi (BIT:1SAN)
Historical Stock Chart
Von Apr 2023 bis Apr 2024