20-May-2020

Sanofi to showcase oncology portfolio and innovative pipeline at ASCO20 Virtual Scientific Program

Emerging data demonstrate commitment to advancing cancer care, including two fully in-house investigational compounds: a potential best-in-class oral SERD for breast cancer and a first-in-class anti-CEACAM5 antibody-drug conjugate for non-small cell lung cancer
Positive data for Libtayo® (cemiplimab-rwlc) from largest-ever prospective clinical dataset of PD-1 inhibitors in advanced cutaneous squamous cell carcinoma to be presented
New data for Sarclisa® (isatuximab-irfc) and Jevtana® (cabazitaxel) in difficult-to-treat cancers reinforce breadth and depth of portfolio

Cambridge, MA – May 13, 2020 – Sanofi will present data from across its oncology franchise, including portfolio and pipeline compounds, during the upcoming American Society of Clinical Oncology (ASCO) Virtual Scientific Program from May 29-31. Among the abstracts are new research highlighting the company’s leadership and commitment to the care of patients with non-melanoma skin cancer, prostate cancer, and multiple myeloma, and early stage clinical data for two potentially transformative therapies for breast and lung cancer.

“We are determined to improve the outcomes for patients with cancer by developing transformative therapies, and this is a pivotal time to continue our commitment to patients and the oncology community,” said Dietmar Berger, Global Head of Clinical Development and Chief Medical Officer. "We are fortunate to have recently welcomed Dr. Peter C. Adamson to lead our Global Oncology Development team, and he will continue to oversee our emerging pipeline. We are at the forefront of translating scientific advances into potential new treatments in our pipeline, and focused on addressing critical gaps that may help advance the care of several difficult-to-treat cancers."

Early-stage clinical results support innovative approaches in metastatic breast cancer and advanced non-small cell lung cancer

"Building upon advances in molecular- and immuno- oncology, our portfolio and pipeline strategy leverage leading-edge technology platforms to develop better therapies for patients with diverse malignancies including skin, blood, breast and lung cancers”, said Peter C. Adamson, Global Development Head, Oncology and Pediatric Innovation. “We are leading the way with our investigational oral SERD that can serve as potential backbone treatment across multiple lines of therapy for patients with ER+ breast cancer, and our first-in-class investigational compound CEACAM5 antibody-drug conjugate for patients with lung cancer or potentially other CEACAM5-expressing solid tumors. We are excited to share early clinical and proof of concept data on both at the upcoming ASCO20 virtual meeting.”

In the U.S., more than 154,000 women are estimated to have metastatic breast cancer (mBC) and approximately 79% of breast cancers are estrogen receptor (ER) positive. SAR439859 is an investigational oral selective estrogen receptor degrader (SERD), a potential best-in-class small molecule targeted therapy that binds to ERs in breast cancer cells to inhibit ER signaling and trigger their degradation.

Abstract 1070: Phase 1/2 study of SAR439859, an oral selective estrogen receptor degrader (SERD), in estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (mBC) (TED14856 - Part A and B data)
Abstract TPS1108: Phase 2 preoperative window study of SAR439859 versus letrozole in post-menopausal women with newly diagnosed estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer
Abstract TPS1107: Phase 2 trial of SAR439859 vs endocrine monotherapy in pre- and post-menopausal, estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2−), locally advanced or metastatic breast cancer (BC) with prior exposure to hormonal therapies

Non-small cell lung cancer (NSCLC) is the most common type of lung cancer and accounts for 84% of all diagnoses. CEACAM5 is a cell-surface glycoprotein highly expressed in several tumor types, including NSCLC. Approximately 20% of lung cancers have a high expression of CEACAM5. Data will be presented on our first-in-class CEACAM5 antibody-drug conjugate during an oral presentation at ASCO20.

Abstract 9505: Efficacy and safety of the antibody-drug conjugate (ADC) SAR408701 in non-squamous non-small cell lung cancer (NSQ NSCLC) patients (pts) expressing carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) (Oral presentation)
Abstract TPS9625: Phase 3 trial comparing antibody-drug conjugate (ADC) SAR408701 with docetaxel in patients with metastatic non-squamous non-small cell lung cancer (NSQ NSCLC) failing chemotherapy and immunotherapy

Long-term data for Libtayo® (cemiplimab-rwlc) in advanced CSCC

Cutaneous squamous cell carcinoma (CSCC) is one of the most commonly diagnosed skin cancers worldwide, and although the majority of patients have a good prognosis when the cancer is discovered early, it can be especially difficult to treat successfully when it progresses to advanced stages. - New longer-term data from the pivotal Phase 2 study of Libtayo offer updated efficacy and safety outcomes that add to the most mature dataset for any therapy in advanced CSCC. 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. Libtayo is a PD-1 immune checkpoint inhibitor being jointly developed with Regeneron under a global collaboration agreement.

Abstract 10018: Phase 2 study of cemiplimab in patients with advanced cutaneous squamous cell carcinoma: longer follow-up
Abstract TPS10084: A Phase 3, randomized, double-blind study of adjuvant cemiplimab versus placebo post-surgery and radiation therapy (RT) in patients (pts) with high-risk cutaneous squamous cell carcinoma (CSCC)
Abstract 10033: Health-related quality of life in patients with advanced cutaneous squamous cell carcinoma treated with cemiplimab: post hoc exploratory analysis of a phase 2 clinical trial
On-line Publication: Patterns of hedgehog inhibitor treatment interruptions and re-initiations among patients with basal cell carcinoma in real-world clinical practice
On-line Publication: Assessing the value of cemiplimab for adults with advanced cutaneous squamous cell carcinoma: a cost-effectiveness analysis

Growing body of evidence in multiple myeloma and metastatic castration-resistant prostate cancer

Multiple myeloma (MM) is the second most common hematologic malignancy, and, despite available treatments, the disease is associated with significant patient burden. Results from a Phase 1b study evaluating Sarclisa® (isatuximab-irfc) in newly diagnosed MM patients who are ineligible for transplant add to a growing body of positive data. Sarclisa, a monoclonal antibody that binds to the CD38 receptor on MM cells, is approved for use in the U.S. in combination with pomalidomide and dexamethasone for the treatment of adults who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.

Abstract 8529: Updates from a Phase Ib study of isatuximab, bortezomib and dexamethasone plus cyclophosphamide or lenalidomide in transplant ineligible newly diagnosed multiple myeloma

Prostate cancer is a very heterogenous disease and one of the most common types of cancer in men. Metastatic castration-resistant prostate cancer (mCRPC) is prostate cancer that has spread beyond the prostate gland and progressed despite androgen deprivation therapy. Results from a post-hoc analysis of the CARD clinical trial highlight that overall survival was significantly longer with Jevtana® (cabazitaxel) versus abiraterone or enzalutamide in patients with mCRPC who had been previously treated with docetaxel and had disease progression within 12 months on a prior androgen receptor-targeted agent.

Abstract 5569: CARD: Overall survival (OS) analysis of patients with metastatic castration-resistant prostate cancer (mCRPC) receiving cabazitaxel vs abiraterone or enzalutamide
Abstract 5559: Efficacy and safety in older patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) receiving cabazitaxel (CBZ) vs abiraterone (ABI) or enzalutamide (ENZ) in the CARD study
Abstract 5558: Pain progression at initiation of cabazitaxel in metastatic Castration-Resistant Prostate Cancer (mCRPC) is associated with a poor prognosis: a post-hoc analysis of PROSELICA

Additional research at ASCO20 Virtual Meeting supported by Sanofi include:

*Sarclisa (isatuximab-irfc)*
Abstract 8508	Depth of Response to Isatuximab, Carfilzomib, Lenalidomide and Dexamethasone (Isa-KRd ) in Front-Line Treatment of High-Risk Multiple Myeloma: Interim Analysis of the GMMG-CONCEPT Trial
*Mozobil (plerixafor)*
On-line publication	Real World Stem Cell Mobilization (PBSC) Patterns in MM Pts Receiving Autologous Transplant (ASCT)
*Eloxatin (oxaliplatin)*
Abstract 3522	Longitudinal Cumulative Dose: A Novel Measure to Assess Multiple Dimensions of Chemotherapy Adherence Over Time
Abstract 7067	Effectiveness of adjuvant FOLFOX vs 5FU for colon cancer treatment in community oncology practice using a hybrid study approach
*Taxotere (docetaxel)*
Abstract 4551	Diagnostic accuracy of CT-staging of advanced gastric cancer following neoadjuvant chemotherapy.
*Jevtana® (cabazitaxel)*
Abstract 11556	Activity of cabazitaxel in patients with metastatic or inoperable locally advanced dedifferentiated liposarcoma. European Organization for Research and Treatment of Cancer (EORTC) Phase 2 trial 1202

About Libtayo

Libtayo is approved in the U.S., EU, and other countries for adult patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. In the U.S., the generic name for Libtayo 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.

The extensive clinical program for Libtayo is focused on difficult-to-treat cancers. In skin cancer, this includes a potentially registrational Phase 2 trial in basal cell carcinoma, a Phase 3 trial in adjuvant setting in CSCC, and additional and neoadjuvant CSCC. . Libtayo is also being investigated in potentially registrational Phase 3 trials in non-small cell lung cancer and cervical cancer, as well as in trials combining Libtayo with 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 Sarclisa

Sarclisa is a monoclonal antibody that binds to the CD38 receptor on multiple myeloma cells. CD38 is highly and uniformly expressed on multiple myeloma cells and cell surface receptors, making it a target for antibody-based therapeutics such as Sarclisa. It is designed to induce programmed tumor cell death (apoptosis) and immunomodulatory activity.

Sarclisa is approved in the U.S. in combination with pomalidomide and dexamethasone for the treatment of adults with relapsed refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. In the U.S., the generic name for Sarclisa is isatuximab-irfc, with irfc as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the U.S. Food and Drug Administration.

Sarclisa has also received a positive CHMP opinion in combination with pomalidomide and dexamethasone for the treatment of adults with relapsed and refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy. A final decision on the Marketing Authorisation Application for Sarclisa in the E.U. is expected in the coming months. The safety and efficacy of Sarclisa have not been fully evaluated by any regulatory authority outside of the U.S., Switzerland, Canada, and Australia.

Sarclisa continues to be evaluated in multiple ongoing Phase 3 clinical trials in combination with current standard treatments across the multiple myeloma treatment continuum. It is also under investigation for the treatment of other hematologic malignancies and solid tumors. These potential uses are investigational, and their safety and efficacy have not been evaluated by any regulatory authority.

About Jevtana (cabazitaxel)

Jevtana is a semi-synthetic taxane chemotherapy. Jevtana is a microtubule inhibitor that binds to tubulin and promotes its assembly into microtubules while simultaneously inhibiting disassembly. This leads to the stabilization of microtubules, which results in the inhibition of mitotic and interphase cellular functions.

Jevtana is indicated, in combination with prednisone, for the treatment of adult men with mCRPC previously treated with a docetaxel-containing treatment regimen.

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR U.S. PATIENTS

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.

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.

For more information, please see full Prescribing Information, including Medication Guide.

What is SARCLISA?

SARCLISA is a prescription medicine used in combination with pomalidomide and dexamethasone to treat adults who have received at least 2 prior therapies, including lenalidomide and a proteasome inhibitor, to treat multiple myeloma.

It is not known if SARCLISA is safe and effective in children.

Do not receive SARCLISA if you have a history of severe allergic reaction to isatuximab-irfc or any of the ingredients in SARCLISA (see the list of ingredients in full Prescribing Information).

Before receiving SARCLISA, tell your healthcare provider about all of your medical conditions, including if you:

are pregnant or plan to become pregnant. SARCLISA may harm your unborn baby. You should not receive SARCLISA during pregnancy.
Females who are able to become pregnant should use an effective method of birth control during treatment and for 5 months after your last dose of SARCLISA. Talk to your healthcare provider about birth control methods that you can use during this time.

Tell your healthcare provider right away if you think you are pregnant or become pregnant during treatment with SARCLISA.
are breastfeeding or plan to breastfeed. It is not known if SARCLISA passes into your breast milk. You should not breastfeed during treatment with SARCLISA.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will I receive SARCLISA?

SARCLISA will be given to you by your healthcare provider by intravenous (IV) infusion into your vein.
SARCLISA is given in treatment cycles of 28 days (4 weeks), together with the medicines pomalidomide and dexamethasone.
In cycle 1, SARCLISA is usually given weekly.
Starting in cycle 2, SARCLISA is usually given every 2 weeks.

Your healthcare provider will decide how long you should receive SARCLISA.
If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.
Your healthcare provider will give you medicines before each dose of SARCLISA to help reduce the risk of infusion reactions (make them less frequent and severe).

What are the possible side effects of SARCLISA?

SARCLISA may cause serious side effects, including:

Infusion reactions. Infusion reactions are common with SARCLISA and can sometimes be severe.
Your healthcare provider will prescribe medicines before each infusion of SARCLISA to help decrease your risk for infusion reactions or to help make any infusion reaction less severe. You will be monitored for infusion reactions during each dose of SARCLISA.
Your healthcare provider may slow down or stop your infusion, or completely stop treatment with SARCLISA, if you have an infusion reaction.

Tell your healthcare provider right away if you develop any of the following symptoms of infusion reaction during or within 24 hours after an infusion of SARCLISA:

feeling short of breath
cough
chills
nausea
Decreased white blood cell counts. Decreased white blood cell counts are common with SARCLISA and certain white blood cells can be severely decreased. You may have an increased risk of getting certain infections, such as upper and lower respiratory infections.

Your healthcare provider will check your blood cell counts during treatment with SARCLISA. Your healthcare provider may prescribe an antibiotic or antiviral medicine to help prevent infection, or a medicine to help increase your white blood cell counts during treatment with SARCLISA.

Tell your healthcare provider right away if you develop any fever or symptoms of infection during treatment with SARCLISA.

Risk of new cancers. New cancers have happened in people during treatment with SARCLISA. Your healthcare provider will monitor you for new cancers during treatment with SARCLISA.
Change in blood tests. SARCLISA can affect the results of blood tests to match your blood type. Your healthcare provider will do blood tests to match your blood type before you start treatment with SARCLISA. Tell all of your healthcare providers that you are being treated with SARCLISA before receiving blood transfusions.

The most common side effects of SARCLISA include:

lung infection (pneumonia)
decreased red blood cell counts (anemia)
upper respiratory tract infection
decreased platelet counts (thrombocytopenia)
diarrhea

These are not all the possible side effects of SARCLISA. For more information, ask your healthcare provider or pharmacist.

Please see full Prescribing Information, including Patient Information.

What is JEVTANA?

JEVTANA is a prescription medicine used with the steroid medicine prednisone. JEVTANA is used to treat men with castration-resistant prostate cancer (prostate cancer that is resistant to medical or surgical treatments that lower testosterone) that has spread to other parts of the body, and that has worsened (progressed) after treatment with other medicines that included docetaxel.

It is not known if JEVTANA is safe and effective in children.

What is the most important information I should know about JEVTANA?

JEVTANA may cause serious side effects, including:

Low white blood cells, which can cause you to get serious infections, and may lead to death. Men who are 65 years or older may be more likely to have these problems. Your healthcare provider (HCP):

will do blood tests regularly to check your white blood cell counts during your treatment with JEVTANA.
may lower your dose of JEVTANA, change how often you receive it, or stop JEVTANA until your HCP decides that you have enough white blood cells.
may prescribe a medicine for you called G-CSF, to help prevent complications if your white blood cell count is too low.

Tell your HCP right away if you have any of these symptoms of infection during treatment with JEVTANA: fever (take your temperature often during treatment with JEVTANA), cough, burning during urination, or muscle aches. Also, tell your HCP if you have any diarrhea during the time that your white blood cell count is low. Your HCP may prescribe treatment for you as needed.

Severe allergic reactions can happen within a few minutes after your infusion of JEVTANA starts, especially during the first and second infusions. Your HCP should prescribe medicines before each infusion to help prevent severe allergic reactions.

Tell your HCP right away if you have any of these symptoms of a severe allergic reaction during or soon after an infusion of JEVTANA: rash or itching, skin redness, feeling dizzy or faint, breathing problems, chest or throat tightness, or swelling of face.
Severe stomach and intestine (gastrointestinal) problems.
JEVTANA can cause severe vomiting and diarrhea, which may lead to death. Severe vomiting and diarrhea with JEVTANA can lead to loss of too much body fluid (dehydration), or too much of your body salts (electrolytes). Death has happened from having severe diarrhea and losing too much body fluid or body salts with JEVTANA. You may need to go to the hospital for treatment. Your HCP will prescribe medicines to prevent or treat vomiting and diarrhea, as needed with JEVTANA. Tell your HCP if you have vomiting or diarrhea, or if your symptoms get worse or do not get better.
JEVTANA can cause a leak in the stomach or intestine, intestinal blockage, infection, and bleeding in the stomach or intestine, which may lead to death. Tell your HCP if you get any of these symptoms: severe stomach-area (abdomen) pain, constipation, fever, blood in your stool, or changes in the color of your stool
Kidney failure may happen with JEVTANA, because of severe infection, loss of too much body fluid (dehydration), and other reasons, which may lead to death. Your HCP will check you for this problem and treat you if needed.

Tell your HCP if you develop these signs or symptoms: swelling of your face or body, decrease in the amount of urine that your body makes each day or blood in your urine.

Inflammation of the bladder and blood in the urine. Blood in the urine is common with JEVTANA, but it can also sometimes be severe. Some people who have had pelvic radiation in the past may develop inflammation of the bladder and blood in the urine that is severe enough that they may need to be hospitalized for medical treatment or surgery. Your healthcare provider will check you for these problems during treatment with JEVTANA. Your healthcare provider may stop your treatment with JEVTANA for a short time, or permanently, if you develop inflammation of the bladder and bleeding that is severe.
Lung or breathing problems may happen with JEVTANA and may lead to death. Men who have lung disease before receiving JEVTANA may have a higher risk for developing lung or breathing problems with JEVTANA treatment. Your HCP will check you for this problem and treat you if needed. Tell your HCP right away if you develop any new or worsening symptoms, including trouble breathing, shortness of breath, chest pain, cough or fever.

Who should not receive JEVTANA?

Do not receive JEVTANA if: your white blood cell (neutrophil count) is too low, you have had a severe allergic reaction to cabazitaxel or other medicines that contain polysorbate 80 (ask your HCP if you are not sure), you have severe liver problems.

What should I tell my HCP before receiving JEVTANA?

Before receiving JEVTANA, tell your HCP if you:

are age 65 or older
had allergic reactions in the past
have kidney or liver problems
have lung problems
are pregnant or plant to become pregnant. JEVTANA can cause harm to your unborn baby and loss of pregnancy (miscarriage).
are a male with a female partner who is able to become pregnant. Males should use effective birth control (contraception) during treatment with JEVTANA and for 3 months after the last dose of JEVTANA.

JEVTANA may cause fertility problems in males. This may affect your ability to father a child. Talk to your HCP if you have concerns about fertility.

Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. JEVTANA can interact with many other medicines. Do not take any new medicines without asking your HCP first. Your HCP will tell you if it is safe to take the new medicine with JEVTANA.

What are the most common side effects of JEVTANA?

The most common side effects of JEVTANA include:

low red blood cell count (anemia), which is common with JEVTANA, but can sometimes also be serious. Your HCP will regularly check your red blood cell count. Symptoms of anemia include shortness of breath and tiredness.
low blood platelet count, which is common with JEVTANA, but can sometimes also be serious. Tell your HCP if you have any unusual bruising or bleeding.
fever
Back pain
diarrhea
Change in your sense of appetite
tiredness
decreased appetite
nausea
shortness of breath
vomiting
cough
constipation
hair loss
weakness
numbness, tingling, burning or decreased sensation in your hands or feet
stomach (abdominal) pain

Tell your HCP if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of JEVTANA. For more information, ask your HCP or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see full Pre scribing Information/Patient Information, including Serious Side Effects.

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 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, 2019. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

___________________________________________________

[1] Metastatic Breast Cancer Introduction. Susan G. Komen website. https://ww5.komen.org/BreastCancer/MetastaticBreastCancerIntroduction.html. Accessed April 17, 2020.

[1] Li Y, et al. Clinicopathology Characteristics and Breast Cancer-Specific Survival of Patients with Single Hormone Receptor-Positive Breast Cancer. JAMA Netw Open. 2020;3(1):e1918160.

[1] Lung Cancer – Non Small Cell: Statistics. Cancer.net. https://www.cancer.net/cancer-types/lung-cancer-non-small-cell/statistics. Accessed April 17, 2020.

[1] 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.

[1] 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.

[1] Skin cancer treatment (PDQ®). National Cancer Institute website. https://www.cancer.gov/types/skin/hp/skin-treatment-pdq. Updated February 1, 2018. Accessed April 17, 2020.

[1] Jennings L, Schmults CD. Management of high-risk cutaneous squamous cell carcinoma. J Clin Aesthet Dermatol. 2010;3(4):39-48.

[1] 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.

[1] Kazandjian. Multiple myeloma epidemiology and survival: A unique malignancy. Semin Oncol. 2016;43(6):676-681. doi:10.1053/j/seminoncol.2016.11.004.

[1] Boyd LK, Mao X, Lu YJ. The complexity of prostate cancer: genomic alterations and heterogeneity. Nat Rev Urol. 2012 Nov;9(11):652-64. https://www.ncbi.nlm.nih.gov/pubmed/23132303.

[1] Saad F, Hotte S. Guidelines for the management of castrate-resistant prostate cancer. Can Urol Assoc J 2010;4(6):380-4. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2997826/pdf/cuaj-6-380.pdf.

Sanofi Media Relations Contact
Sally Bain
Tel.: +1 617 834 6026
sally.bain@sanofi.com

Sanofi Investor Relations Contact
Felix Lauscher
Tel.: +33 (0)1 53 77 45 45
ir@sanofi.com

+++

Sanofi pipeline and portfolio in multiple myeloma and cold agglutinin disease featured at the annual European Hematology Association Virtual Congress

Clinical data to be presented for SarclisaÒ (isatuximab) in investigational settings of multiple myeloma, including newly diagnosed, relapsed refractory, and high-risk patients
Quality of life data for investigational sutimlimab in patients with cold agglutinin disease to be featured in oral presentation

Cambridge, MA – May 14, 2020 -- Clinical data in challenging blood cancers, rare blood disorders and rare disease featuring Sanofi investigational and marketed therapies will be presented at the 25th Annual European Hematology Association (EHA) Virtual Congress (EHA25) June 11-14, 2020.

“Some of the most serious unmet patient needs today are in the field of hematology, and we are committed to investigating ways to significantly improve the health of people suffering from challenging blood cancers and rare blood disorders,” said Bill Sibold, EVP, Specialty Care at Sanofi Genzyme. “The data featured at EHA have the potential to transform care and outcomes for patients on a global scale.”

In line with EHA25 embargo policies, for poster and oral presentations the embargo is lifted at the beginning of the EHA25 Press Briefing on Friday June 12, 8:30 AM CEST.

Clinical data evaluating SarclisaÒ (isatuximab) in difficult-to-treat blood cancers

Multiple myeloma (MM) is the second most common hematologic malignancy. Despite available treatments, MM remains incurable and is associated with significant patient burden. Since MM does not have a cure, most patients will relapse.

Data will be presented exploring the impact of our anti-CD38 mAb isatuximab in combination with other therapies in newly diagnosed patients with MM. Depth of response data in newly diagnosed high-risk MM patients will be featured as an oral presentation.

Abstract #S204 (ISS): Depth of Response to Isatuximab, Carfilzomib, Lenalidomide and Dexamethasone (Isa-KRd) in Front-Line Treatment of High-Risk Multiple Myeloma: Interim Analysis of the GMMG-CONCEPT Trial. Oral Presentation
Abstract #EP987 (ISS): Mobilization of Autologous Stem Cells Under Induction Therapy with Isatuximab, Carfilzomib, Lenalidomide, Dexamethasone (Isa-KRd) in High-Risk Myeloma Patients: First Results of the GMMG-CONCEPT Trial. Poster Presentation
Abstract #EP983: Updates from a Phase Ib Study of Isatuximab, Bortezomib and Dexamethasone Plus Cyclophosphamide or Lenalidomide in Transplant Ineligible Newly Diagnosed Multiple Myeloma. Poster Presentation

New data with isatuximab in relapsed refractory MM explore insights from various subpopulations, including heavily pre-treated and renally impaired patients, from multiple trials.

Abstract #EP1009: Isatuximab Short-Duration Fixed-Volume Infusion Combination Therapy for Relapsed/Refractory Multiple Myeloma: Final Results of a Phase 1b Feasibility/Safety Study. Poster Presentation
Abstract #EP1017: Isatuximab plus Pomalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma Patients with 1q21 Gain: Insights from Phase 1 and Phase 3 Studies. Poster Presentation
Abstract #EP1028: Health-Related Quality of Life in Heavily Pre-Treated and Renally Impaired Patients with Relapsed/Refractory Multiple Myeloma Receiving Isatuximab plus Pomalidomide and Dexamethasone: ICARIA-MM Study. Poster Presentation

In addition to MM, data with isatuximab will be presented in Acute Myeloid Leukemia (AML), which is a rapid, aggressive and progressive cancer. New data explore the mode of action of anti-CD38 mAb isatuximab in this difficult-to-treat cancer.

Abstract #EP467: The Mode of Action of the Anti-CD38 Monoclonal Antibody Isatuximab in Acute Myeloid Leukemia. Poster Presentation

Advancing research addressing treatment gaps for rare blood disorders

Cold agglutinin disease (CAD) is a chronic and rare autoimmune hemolytic anemia that causes the body’s immune system to mistakenly attack healthy red blood cells and cause their rupture (hemolysis). CAD patients may experience chronic anemia, profound fatigue, acute hemolytic crisis, and other potential complications, including an increased risk of thromboembolic events and early death.ii,iii,iv CAD affects an estimated 12,000 people in the United States, Europe and Japan and there are currently no approved therapies.

We will present retrospective analyses of the Optum® database assessing the potential for serious complications for patients with CAD.

Abstract #S329: Impact of Cold Agglutinin Disease Real-world Treatments on Thrombosis and Mortality—A United States Electronic Heath Record Database Analysis. Oral Presentation
Abstract #EP1565: Increased Hemolysis Markers Are Predictors of Mortality in Patients With Cold Agglutinin Disease—Real-world Evidence From a United States Electronic Health Record Database. Poster Presentation

We will present an overview of the CADENCE registry, which will examine the natural history of CAD, the long-term impact of the comorbidities associated with the disease and the outcomes of various treatments.

Abstract #EP1618: Cold Agglutinin Disease (CAD) Real World Evidence (CADENCE) Registry: the Design of the First International, Prospective CAD Registry. Poster Presentation

New data from the pivotal Phase 3 trial of sutimlimab, our investigational monoclonal antibody designed to selectively inhibit C1s, and potential first-in-class therapy, evaluate the impact of sutimlimab on quality of life in patients with CAD.

Abstract #S333: Sutimlimab, a Complement C1s Inhibitor, Improves Quality of Life in Patients with Cold Agglutinin Disease: Patient-Reported Outcomes Results of the Phase 3 Cardinal Study. Oral Presentation

Additional data from a Phase 1 study explore the potential of sutimlimab in immune thrombocytopenia purpura, a rare autoimmune disease where the body destroys healthy platelets leading to excessive bruising and bleeding.

Abstract #EP1630: Inhibition of the Classical Complement Pathway With Sutimlimab in Patients With Chronic Immune Thrombocytopenia Without Adequate Response to Two or More Prior Therapies. Poster Presentation

Acquired thrombotic thrombocytopenic purpura (aTTP) is a rare, life-threatening, autoimmune blood disorder and is considered an urgent, medical emergency. New investigational data for Cablivi® (caplacizumab-yhdp), our first-in-class treatment in combination with plasma exchange and immunosuppressive therapy for adult patients with aTTP will be presented.

Abstract #EP1626: Caplacizumab Induces Fast and Durable Platelet Count Responses With Improved Time to Complete Remission and Recurrence-Free Survival in Patients With Acquired Thrombotic Thrombocytopenic Purpura. Poster Presentation
Abstract #EP1729: Survivorship in Acute Acquired Thrombotic Thrombocytopenic Purpura (aTTP) – Impacts on Quality of Life (QoL) and Cognitive Functioning in Patients from the UK. Poster Presentation
Abstract #PB2477: Early Engagement of the ‘Patient Voice’ to Inform Selection of Outcome Measures in Rare Disease: an Example from a Survey Study in Acquired Thrombotic Thrombocytopenic Purpura (aTTP). Poster Presentation

Registry analysis of malignancies in Gaucher disease

Abstract #EP1044: Hematologic malignancies and gammopathies in Gaucher disease type 1. Poster Presentation

About Sarclisa (isatuximab)

Isatuximab is an anti-CD38 mAb that binds to the CD38 receptor on MM cells. It is designed to induce programmed tumor cell death (apoptosis) and immunomodulatory activity. CD38 is highly and uniformly expressed on MM cells and cell surface receptors, making it a target for antibody-based therapeutics such as isatuximab.

Isatuximab was approved by the U.S. Food and Drug Administration (FDA) in March 2020 under the trade name Sarclisa® (isatuximab-irfc), in combination with pomalidomide and dexamethasone (pom-dex), for the treatment of adults with relapsed refractory MM who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. In the U.S., the generic name for Sarclisa is isatuximab-irfc, with irfc as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the U.S. Food and Drug Administration.

Also in March 2020, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for isatuximab in combination with pom-dex for the treatment of adult patients with relapsed and refractory MM who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy. A decision from the EMA on the Marketing Authorization Application for isatuximab in the E.U. is expected this quarter. Sarclisa has not been approved for commercial use in the E.U.

Isatuximab continues to be evaluated in multiple ongoing Phase 3 clinical trials in combination with current standard treatments across the myeloma treatment continuum. It is also under investigation for the treatment of other blood cancer types (hematologic malignancies) and solid tumors. The safety and efficacy of these additional uses have not been reviewed by any regulatory authority worldwide.

What is SARCLISA?

It is not known if SARCLISA is safe and effective in children.

Do not receive SARCLISA if you have a history of severe allergic reaction to isatuximab-irfc or any of the ingredients in SARCLISA (see the list of ingredients in full Prescribing Information).

Before receiving SARCLISA, tell your healthcare provider about all of your medical conditions, including if you:

are pregnant or plan to become pregnant. SARCLISA may harm your unborn baby. You should not receive SARCLISA during pregnancy.
Females who are able to become pregnant should use an effective method of birth control during treatment and for 5 months after your last dose of SARCLISA. Talk to your healthcare provider about birth control methods that you can use during this time.

Tell your healthcare provider right away if you think you are pregnant or become pregnant during treatment with SARCLISA.
are breastfeeding or plan to breastfeed. It is not known if SARCLISA passes into your breast milk. You should not breastfeed during treatment with SARCLISA.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will I receive SARCLISA?

SARCLISA will be given to you by your healthcare provider by intravenous (IV) infusion into your vein.
SARCLISA is given in treatment cycles of 28 days (4 weeks), together with the medicines pomalidomide and dexamethasone.
In cycle 1, SARCLISA is usually given weekly.
Starting in cycle 2, SARCLISA is usually given every 2 weeks.

Your healthcare provider will decide how long you should receive SARCLISA.
If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.
Your healthcare provider will give you medicines before each dose of SARCLISA to help reduce the risk of infusion reactions (make them less frequent and severe).

What are the possible side effects of SARCLISA?

SARCLISA may cause serious side effects, including:

Infusion reactions. Infusion reactions are common with SARCLISA and can sometimes be severe.
Your healthcare provider will prescribe medicines before each infusion of SARCLISA to help decrease your risk for infusion reactions or to help make any infusion reaction less severe. You will be monitored for infusion reactions during each dose of SARCLISA.
Your healthcare provider may slow down or stop your infusion, or completely stop treatment with SARCLISA, if you have an infusion reaction.

Tell your healthcare provider right away if you develop any of the following symptoms of infusion reaction during or within 24 hours after an infusion of SARCLISA:

feeling short of breath
cough
chills
nausea
Decreased white blood cell counts. Decreased white blood cell counts are common with SARCLISA and certain white blood cells can be severely decreased. You may have an increased risk of getting certain infections, such as upper and lower respiratory infections.

Your healthcare provider will check your blood cell counts during treatment with SARCLISA. Your healthcare provider may prescribe an antibiotic or antiviral medicine to help prevent infection, or a medicine to help increase your white blood cell counts during treatment with SARCLISA.

Tell your healthcare provider right away if you develop any fever or symptoms of infection during treatment with SARCLISA.
Risk of new cancers. New cancers have happened in people during treatment with SARCLISA. Your healthcare provider will monitor you for new cancers during treatment with SARCLISA.
Change in blood tests. SARCLISA can affect the results of blood tests to match your blood type. Your healthcare provider will do blood tests to match your blood type before you start treatment with SARCLISA. Tell all of your healthcare providers that you are being treated with SARCLISA before receiving blood transfusions.
The most common side effects of SARCLISA include:

lung infection (pneumonia)
decreased red blood cell counts (anemia)
upper respiratory tract infection
decreased platelet counts (thrombocytopenia)
diarrhea

These are not all the possible side effects of SARCLISA. For more information, ask your healthcare provider or pharmacist.

Please see full Prescribing Information, including Patient Information.

About Sutimlimab

Sutimlimab is monoclonal antibody designed to target and inhibit C1s, a serine protease within the C1-complex in the classical complement pathway of the immune system, which is thought to directly impact the central mechanism of hemolysis in CAD. Similarly, the classical complement pathway has been shown to contribute to the physiopathology of immune thrombocytopenic purpura (ITP). With a unique mechanism of action and high target specificity, sutimlimab is designed to selectively inhibit disease processes by upstream blockade of the classical complement pathway while aiming to maintain activity of the alternative and lectin complement pathways.

Sutimlimab is currently under review by the US Food and Drug Administration as a potential treatment for C1-activated hemolysis in adult patients with CAD based on data from the pivotal Phase 3 Cardinal study. No conclusions can or should be drawn regarding the safety or effectiveness of this investigational therapeutic.

About Cablivi

Cablivi was developed by Ablynx, which was acquired by Sanofi in 2018. Cablivi was approved in the European Union in August 2018 and in the United States in February 2019. Cablivi is part of the company's rare blood disorders franchise within Sanofi Genzyme, the specialty care global business unit of Sanofi.

CABLIVI IMPORTANT SAFETY INFORMATION

What is CABLIVI?

CABLIVI (caplacizumab-yhdp) is a prescription medicine used for the treatment of adults with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy.

Who should not take CABLIVI?

Do not take CABLIVI if you've had an allergic reaction to caplacizumab-yhdp or to any of the ingredients in CABLIVI.

What should I tell my healthcare team before starting CABLIVI?

Tell your doctor if you have a medical condition including if you have a bleeding disorder. Tell your doctor about any medicines you take.

Talk to your doctor before scheduling any surgery, medical or dental procedure.

What are the possible side effects of CABLIVI?

CABLIVI can cause severe bleeding. In clinical studies, severe bleeding adverse reactions of nosebleed, bleeding from the gums, bleeding in the stomach or intestines, and bleeding from the uterus were each reported in 1% of subjects. Contact your doctor immediately if excessive bleeding or bruising occur.

You may have a higher risk of bleeding if you have a bleeding disorder (i.e Hemophilia) or if you take other medicines that increase your risk of bleeding such as anti-coagulants.

CABLIVI should be stopped for 7 days before surgery or any medical or dental procedure. Talk to your doctor before you stop taking CABLIVI.

The most common side effects include nosebleed, headache and bleeding gums.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of CABLIVI. Call your doctor for medical advice about side effects.

Click here for full prescribing information.

About Sanofi

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life

Sanofi Forward-Looking Statements

Editor Details

Company:
- Sanofi
Name:
- Sanofi

Last Updated: 20-May-2020