CAMBRIDGE, Mass., May 15, 2019 /PRNewswire/ -- Sanofi's
oncology franchise and robust pipeline will be featured at the 2019
American Society of Clinical Oncology (ASCO) Annual Meeting,
delivering against a renewed strategy to address difficult-to-treat
and difficult-to-eradicate cancers, including certain types of
multiple myeloma, skin cancer, breast cancer, and lung cancer.
Four key molecules in clinical development are the pillars of
Sanofi's late-stage and emerging oncology pipeline: isatuximab, an
investigational anti-CD38 monoclonal antibody; Libtayo
(cemiplimab), a PD-1 checkpoint inhibitor in development with
Regeneron; SAR439859, an
investigational oral selective estrogen receptor degrader (SERD);
and SAR408701, an investigational
anti-CEACAM5 antibody drug conjugate.
"We have a strategic focus to address unmet patient needs
across many therapeutic areas at Sanofi, and currently oncology
makes up a sizeable portion of our late-stage pipeline," said
John Reed, Head of Research and
Development at Sanofi. "Our oncology pipeline is flourishing,
offering a progressively expanding diversity of opportunities to
help advance the treatment of a variety of cancers. We are excited
to showcase this progress at ASCO."
Positive results in relapsed/refractory multiple
myeloma
Reed continued, "We are particularly excited to share the
results from our pivotal Phase 3 ICARIA-MM trial of isatuximab in
patients with a difficult-to-treat relapse/refractory multiple
myeloma. This is the first of multiple Phase 3 trials with
isatuximab, our wholly-owned molecule under investigation for the
treatment of multiple myeloma. We look forward to the presentation
of data at ASCO and believe that the ICARIA-MM data serve as the
basis for the first regulatory filings of isatuximab."
- A phase 3 randomized, open-label, multicenter study
comparing isatuximab, pomalidomide, and low-dose dexamethasone
versus pomalidomide and low-dose dexamethasone in patients with
relapsed/refractory multiple myeloma (RRMM) (Dr. Paul Richardson; Sunday,
June 2: Oral Abstract Session, 9:45-12:45 AM, ICARIA presentation,10:57-11:09 AM)
- Treatment patterns in patients with multiple myeloma (MM): A
retrospective study using Medicare data (Dr. Parameswaran Hari; Publication Only)
Growing body of evidence in advanced cutaneous squamous cell
carcinoma
Cutaneous squamous cell carcinoma (CSCC) is one of the most
commonly diagnosed skin cancers worldwide. Although the majority of
patients with CSCC have a good prognosis when the cancer is found
early, the cancer can be especially difficult to treat when it
progresses to advanced stages.i-v New longer-term data
with Libtayo offer updated efficacy and safety outcomes that add to
the growing body of evidence for Libtayo in patients with
metastatic CSCC or locally advanced CSCC who are not candidates for
curative surgery or curative radiation. Libtayo is being jointly
developed by Regeneron and Sanofi under a global collaboration
agreement.
- Primary analysis of Phase 2 results of cemiplimab, a human
monoclonal anti-PD-1, in patients with locally advanced cutaneous
squamous cell carcinoma (Dr. Michael
Migden; Saturday, June 1:
Poster Display, 1:15-4:15 PM and
Poster Discussion, 4:30-6:00 PM)
- Phase 2 study of cemiplimab, a human monoclonal anti-PD-1,
in patients with metastatic cutaneous squamous cell carcinoma
(mCSCC ; Group 1): 12 month follow-up (Dr. Alexander Guminski; Monday, June 3: Poster Display, 1:15-4:15 PM)
- Treatment patterns and outcomes among patients with advanced
cutnaeous squamous cell carcinoma in a US community oncology
setting (Dr. C. Lance Cowey;
Publication Only)
- Patterns of major surgeries among patients diagnosed with
cutaneous squamous cell carcinoma (Chieh-I Chen; Publication
Only)
Evolving evidence in breast and lung cancers
Breast cancer is the second most common form of cancer. An
estimated 70% of breast cancers are estrogen receptor (ER)
positive. SAR439859 is an
investigational oral selective estrogen receptor degrader (SERD), a
small molecule targeted therapy that binds to estrogen receptors in
breast cancer cells to trigger their degradation.
- Dose-escalation study of SAR439859, an oral selective estrogen receptor
(ER) degrader (SERD), in postmenopausal women with ER+/HER2-
metastatic breast cancer (Dr. Aditya Bardia; Poster Display,
Sunday, June 2, 8:00-11:00 AM)
- Phase 1/2 dose-escalation and expansion study investigating
SAR439859 +/- palbociclib in
postmenopausal women with estrogen receptor-positive (ER+)/HER2-
metastatic breast cancer (Dr. Aditya Bardia; Poster Display,
Sunday, June 2, 8:00-11:00 AM)
Carcinoembryonic antigen-related cell adhesion molecule 5
(CEACAM5) is a cell-surface glycoprotein highly expressed in
several tumor types, including non-squamous non-small cell lung
cancer (NSQ NSCLC). Approximately 20% of lung cancers have a high
expression of CEACAM5.
- First-in-human Phase 1 study of the antibody-drug conjugate
(ADC) SAR408701 in advanced solid
tumors: dose-expansion cohort of patients (pts) with non-squamous
non-small cell lung cancer (NSQ NSCLC) (Dr. Anas Gazzah; Poster
Display, Sunday, June 2, 8:00-11:00 AM)
Additional abstracts supported by Sanofi include:
Abstract
title
|
Abstract
number
|
Oral Abstract,
Friday, May 31, 2:45-5:45 PM
|
Updated results from
a randomized phase II study of cabazitaxel
(CAB) versus abiraterone (ABI) or enzalutamide (ENZ) in poor
prognosis metastatic CRPC
|
5003
|
Poster Session,
Saturday, June 1, 1:15-4:15 PM
|
Cell-free DNA as a
biomarker for taxane treatment in advanced
prostate cancer
|
5070
|
Cabazitaxel with
Abiraterone Versus Abiraterone Alone
Randomized Trial for Extensive Disease Following Docetaxel: the
CHAARTED2 Trial: A trial of the ECOG-ACRIN Cancer
Research
Group (EA8153)
|
TPS5094
|
HSD3B1 and Overall
Survival in Men with Low-Volume Metastatic
Disease Treated with Androgen Deprivation Therapy or
Chemohormonal Therapy in the CHAARTED Randomized Trial
|
5020
|
CALGB 90203
(Alliance): Radical prostatectomy (RP) with or
without neoadjuvant chemohormonal therapy (CHT) in men with
clinically localized, high-risk prostate cancer
(CLHRPC).
|
5079
|
Oral Abstract,
Saturday, June 1, 3:00-6:00 PM
|
Association of Colon
Cancer (CC) Molecular Signatures with
Prognosis and Oxaliplatin Prediction-Benefit in the MOSAIC
Trial
(Multicenter International Study of Oxaliplatin/5FU-LV in the
Adjuvant Treatment of Colon Cancer)
|
3503
|
Clinical Science
Symposium, Sunday, June 2, 8:00-9:00 AM
|
Evolutionary action
score of TP53 analysis in pathologically high-
risk HPV-negative head and neck cancer from a phase II clinical
trial: NRG Oncology RTOG 0234
|
6010
|
Poster Session,
Monday, June 3, 8:00-11:00 AM
|
|
Repeated centralized
MDT resectability assessment during first-line
treatment in 1086 Finnish metastatic colorectal cancer (mCRC)
patients nationwide (prospective RAXO study).
|
3517
|
Combination of
tissues analysis and immune infiltrate in localized
colon cancer using Using artificial intelligence in PETACC8
study
|
3574
|
Relative Contribution
of Clinical and Molecular Features to
Outcome Within Low and High Risk T and N Groups in Patients
with Stage III Colon Cancers (Alliance)
|
3520
|
Is the predictive and
prognostic impact of sporadic and familial
microsatellite instable stage III colon cancer different? A
pooled
analysis of the PETACC8 and NCCTG N0147 (Alliance)
trials
|
3583
|
About Isatuximab
Isatuximab is an investigational
anti-CD38 monoclonal antibody (mAb) for the treatment of patients
with relapsed/refractory multiple myeloma. Developed by Sanofi,
isatuximab targets a specific epitope of CD38 capable of triggering
multiple, distinct mechanisms of action that are believed to
promote programmed tumor cell death (apoptosis) and
immunomodulatory activity. CD38 is highly and uniformly expressed
on multiple myeloma cells and is a cell surface receptor target for
antibody-based therapeutics in multiple myeloma and other
malignancies. The clinical significance of these findings is under
investigation.
Isatuximab is currently being evaluated in multiple ongoing
Phase 3 clinical trials in combination with currently available
treatments across the multiple myeloma treatment continuum.
Isatuximab is also under investigation for the treatment of other
hematologic malignancies and solid tumors. Isatuximab is an
investigational agent and its safety and efficacy have not been
evaluated by the U.S. Food and Drug Administration, the European
Medicines Agency, or any other regulatory authority.
About Libtayo
Libtayo is approved in the U.S.,
Canada and Brazil, and is under review by the European
Commission following a positive opinion by the Committee for
Medicinal Products for Human Use (CHMP). In the U.S., Libtayo is
approved for the treatment of patients with metastatic CSCC or
locally advanced CSCC who are not candidates for curative surgery
or curative radiation.vi The generic name for Libtayo in
the U.S. 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.
Libtayo is also being investigated in potential registrational
trials in non-small cell lung cancer, basal cell carcinoma and
cervical cancer, along with additional trials in squamous cell
carcinoma of the head and neck, melanoma, colorectal cancer,
prostate cancer, multiple myeloma, Hodgkin's lymphoma and
non-Hodgkin's lymphoma. These trials are designed to investigate
Libtayo as monotherapy; in combination with conventional treatments
like chemotherapy; or in combination with other investigational
agents, including vaccines, oncolytic viruses and bispecific
antibodies, among others. These potential uses are investigational,
and their safety and efficacy have not been evaluated by any
regulatory authority.
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 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
Media Relations Contact Ashleigh Koss
Tel.: +1 908-981-8745
Ashleigh.Koss@sanofi.com
|
Investor Relations Contact George Grofik
Tel.: +33 (0)1 53 77 45 45
ir@sanofi.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 absence of guarantee that the
product candidates if approved will be commercially successful, the
future approval and commercial success of therapeutic alternatives,
Sanofi's ability to benefit from external growth opportunities
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
conditions, the impact of cost containment initiatives and
subsequent changes thereto, the average number of shares
outstanding as well as those 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, 2018. Other than as required by
applicable law, Sanofi does not undertake any obligation to update
or revise any forward-looking information or
statements.
|
_________________________
i Stratigos, Alexander et al. Diagnosis and treatment of
invasive squamous cell carcinoma of the skin: European
consensus-based interdisciplinary guideline. European Journal of
Cancer, Vol 51(14);14, 1989-2007
ii Califano JA, Lydiatt WM, Nehal KS, et al. Cutaneous squamous
cell carcinoma of the head and neck. In: Amin MB, Edge SB, Greene
FL, et al, eds. AJCC Cancer Staging Manual. 8th ed. Springer;
2017:171-181.
iii Skin cancer treatment (PDQ®). National Cancer Institute
website. https://www.cancer.gov/types/skin/hp/skin-treatment-pdq.
Updated February 1, 2018. Accessed
February 13, 2018.
iv Jennings L, Schmults CD. Management of high-risk cutaneous
squamous cell carcinoma. J Clin Aesthet Dermatol.
2010;3(4):39-48.
v Brunner M, Veness MJ, Ch'ng S, Elliott M, Clark JR. Distant
metastases from cutaneous squamous cell carcinoma—analysis of AJCC
stage IV. Head Neck. 2013;35(1):72-75.
vi LIBTAYO® (cemiplimab-rwlc) full US Prescribing Information.
Regeneron Pharmaceuticals, Inc. / sanofi-aventis U.S.
LLC.
View original
content:http://www.prnewswire.com/news-releases/sanofi-oncology-pipeline-targeting-various-cancers-highlighted-at-asco-2019-300850806.html
SOURCE Sanofi