The Lancet publishes Libtayo® (cemiplimab) data showing
extended overall survival in patients with first-line advanced
non-small cell lung cancer with PD-L1 expression of
³50%
- Libtayo was superior in
extending overall survival compared to chemotherapy even with a
high crossover rate
- Data are the basis for multiple ongoing regulatory submissions,
including in the U.S. and European Union
PARIS and TARRYTOWN, N.Y. – February
12, 2021 – The Lancet today published
results from a pivotal trial designed to evaluate the
investigational use of the PD-1 inhibitor Libtayo® (cemiplimab)
compared to platinum-doublet chemotherapy in patients with locally
advanced or metastatic non-small cell lung cancer (NSCLC) with ≥50%
PD-L1 expression in tumor cells.
The data were shared during a late-breaking
presentation at the 2020 European Society for Medical Oncology
(ESMO) Virtual Congress and formed the basis of regulatory
submissions in the U.S. and European Union (EU). The U.S. Food and
Drug Administration (FDA) granted a Priority Review with a target
action date of February 28, 2021. A European Commission decision is
expected by mid-2021. “These clinical results published in The
Lancet support regulatory submissions for Libtayo as a potential
new treatment option for patients with advanced NSCLC with PD-L1
expression of ≥50%,” said Ahmet Sezer, M.D., Professor in the
Department of Medical Oncology at Başkent University in Adana,
Turkey and a trial investigator. “Libtayo was superior in extending
overall survival compared to chemotherapy, even with 74% of
patients crossing over to the Libtayo arm following progression on
chemotherapy. Libtayo reduced the risk of death by 32% in all
patients in the pivotal trial and by 43% among those with confirmed
PD-L1 expression of 50% or higher. In addition, the data included
more advanced patient populations usually underrepresented in
advanced NSCLC trials – including 12% with pretreated and stable
brain metastases and 16% with locally advanced NSCLC who were not
candidates for definitive chemoradiation. As a result, the medical
community now has valuable new clinical evidence that could enhance
our understanding of how to treat this deadly cancer.”
The safety of Libtayo in the trial was generally consistent with
previous Libtayo pivotal trials, and according to the publication,
consistent with the safety profiles of other PD-1 or PD-L1
inhibitors in NSCLC and other tumor types. Grade 3 or 4 adverse
events occurred in 28% and 39% of patients in the Libtayo and
chemotherapy arms, respectively. Immune-mediated AEs were reported
in 17% of patients in the Libtayo arm, compared to 2% in the
chemotherapy arm, and included hypothyroidism (6% versus 0%),
hyperthyroidism (4% versus <1%), pneumonitis (2% versus 0%),
hepatitis (2% versus 0%), skin adverse reaction (2% versus <1%),
colitis (1% versus <1%), nephritis (<1% versus <1%),
arthritis, increased blood thyroid stimulating hormone,
thyroiditis, and peripheral neuropathy (all <1% versus 0%).
Libtayo is currently approved as the first
systemic treatment in the U.S., EU and other countries for adults
with metastatic cutaneous squamous cell carcinoma (CSCC) or locally
advanced CSCC who are not candidates for curative surgery or
curative radiation. Libtayo is also approved in the U.S. as the
first immunotherapy treatment indicated for patients with advanced
basal cell carcinoma (BCC) previously treated with a hedgehog
pathway inhibitor (HHI) or for whom an HHI is not appropriate, and
is under regulatory review in the EU for the treatment of locally
advanced BCC previously treated with an HHI.
Libtayo is being jointly developed and
commercialized by Sanofi and Regeneron under a global collaboration
agreement.
The use of Libtayo to treat advanced NSCLC is
investigational and has not been fully evaluated by any regulatory
authority.
About the Phase 3 Trial
The open-label, randomized, multi-center Phase 3
trial, called EMPOWER-Lung 1, was designed to investigate the
first-line treatment of Libtayo monotherapy compared to
platinum-doublet chemotherapy in patients with squamous or
non-squamous advanced NSCLC that tested positive for PD-L1 in ≥50%
of tumor cells, but not for ALK, EGFR or ROS1. PD-L1 expression was
confirmed using the PD-L1 IHC 22C3 pharmDx kit. The trial
randomized 710 patients with either locally advanced NSCLC (stage
IIIB/C) who were not candidates for surgical resection or
definitive chemoradiation or had progressed after treatment with
definitive chemoradiation, or previously untreated metastatic NSCLC
(stage IV). Of the 710 patients randomized to receive treatment,
563 patients had confirmed PD-L1 expression of ≥50%.
Patients were randomized 1:1 to receive either
Libtayo 350 mg administered intravenously every three weeks for up
to 108 weeks or an investigator-selected, standard-of-care,
platinum-based, doublet chemotherapy regimen for 4 to 6 cycles
(with or without histology relevant maintenance pemetrexed
chemotherapy). The co-primary endpoints were overall survival and
progression-free survival, and secondary endpoints included overall
response rate, duration of response and quality of life.
The trial was designed to reflect current and
emerging treatment paradigms. Inclusion criteria allowed patients
with NSCLC who had: pre-treated and stable brain metastases;
locally advanced disease that was not a candidate for, or which had
progressed after, definitive chemoradiation; or controlled
hepatitis B, hepatitis C or HIV. Patients whose disease progressed
in the trial were able to change their therapy: those in the
chemotherapy arm were allowed to cross over into the Libtayo arm
following disease progression on chemotherapy; and those in the
Libtayo arm were allowed to combine Libtayo treatment with 4 to 6
cycles of chemotherapy.
About Non-small Cell Lung
Cancer
Lung cancer is the leading cause of cancer death
worldwide. In 2020, an estimated 2.2 million and 225,000 new cases
were diagnosed worldwide and in the U.S, respectively.
Approximately 84% of all lung cancers are NSCLC, and an estimated
25% to 30% of these cases are expected to test positive for PD-L1
in ≥50% of tumor cells. Additionally, an estimated 75% of patients
are diagnosed with advanced NSCLC and have a poor survival
prognosis. While immunotherapies have transformed advanced NSCLC
treatment in recent years, there remains an unmet need to optimize
the identification and treatment of patients with high PD-L1
expression and offer additional treatment options.
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.
In the U.S., the generic name for Libtayo in its
approved indication is cemiplimab-rwlc, with rwlc as the suffix
designated in accordance with Nonproprietary Naming of Biological
Products Guidance for Industry issued by the FDA. Outside of the
U.S., the generic name for Libtayo in its approved indication is
cemiplimab.
The extensive clinical program for Libtayo is
focused on difficult-to-treat cancers. In skin cancer, this
includes trials in adjuvant and neoadjuvant CSCC. Libtayo is also
being investigated in pivotal trials in NSCLC (in combination with
chemotherapy) and cervical cancer, as well as in trials combining
Libtayo with either conventional or novel therapeutic approaches
for both solid tumors and blood cancers. These potential uses are
investigational, and their safety and efficacy have not been
evaluated by any regulatory authority.
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 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, 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. Sanofi, Empowering Life |
|
Sanofi Media Relations Contact Sally Bain
Tel.: +1 (781) 264-1091 Sally.Bain@sanofi.com
Regeneron
Media Relations Contact Daren Kwok Tel.: +1 (914) 847 1328
daren.kwok@regeneron.com |
Sanofi Investor Relations Contacts ParisEva
Schaefer-JansenArnaud DelepineYvonne Naughton Sanofi
Investor Relations Contacts North AmericaFelix
LauscherFara BerkowitzSuzanne Greco Sanofi IR main
line:Tel.: +33 (0)1 53 77 45
45investor.relations@sanofi.comhttps://www.sanofi.com/en/investors/contact
Regeneron Investor Relations ContactVesna
TosicTel: +1 (914) 847-5443vesna.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 and their underlying assumptions, statements
regarding plans, objectives, intentions and expectations with
respect to future financial results, events, operations, services,
product development and potential, and statements regarding future
performance. 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, the uncertainties inherent in research and
development, future clinical data and analysis, including post
marketing, decisions by regulatory authorities, such as the FDA or
the EMA, regarding whether and when to approve any drug, device or
biological application that may be filed for any such product
candidates as well as their decisions regarding labelling and other
matters that could affect the availability or commercial potential
of such product candidates, the fact that product candidates if
approved may not be commercially successful, the future approval
and commercial success of therapeutic alternatives, Sanofi’s
ability to benefit from external growth opportunities, to complete
related transactions and/or obtain regulatory clearances, risks
associated with intellectual property and any related pending or
future litigation and the ultimate outcome of such
litigation, trends in exchange rates and prevailing interest
rates, volatile economic and market conditions, cost containment
initiatives and subsequent changes thereto, 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,
2019. 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); 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
Libtayo for the treatment of locally advanced or metastatic
non-small cell lung cancer, locally advanced basal cell carcinoma
previously treated with a hedgehog pathway inhibitor (in the
European Union and other potential jurisdictions), adjuvant and
neoadjuvant cutaneous squamous cell carcinoma, and cervical cancer
(as well as in combination with either conventional or novel
therapeutic approaches for both solid tumors and blood cancers);
uncertainty of market acceptance and commercial success of
Regeneron’s Products 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 the commercial success of Regeneron’s
Products and Regeneron’s 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; 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; 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 Regeneron’s Product Candidates;
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-COVTM (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. 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). |
|
Sanofi (EU:SAN)
Historical Stock Chart
From Mar 2024 to Apr 2024
Sanofi (EU:SAN)
Historical Stock Chart
From Apr 2023 to Apr 2024