Paris, May 17, 2022. New research at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting from June 3-7 underscores Sanofi’s commitment to improving care across its core focus areas, including multiple myeloma, lung and breast cancers.

Dietmar Berger
Chief Medical Officer, Global Head of Development at Sanofi
“Oncology is a core area for Sanofi, as evidenced by the doubling of our pipeline between 2019 and 2022. As we continue to pursue transformative research to develop advanced medicines for people living with cancer, our portfolio has grown to more than ten therapies in clinical trials. In parallel, we continue to leverage external innovation through strategic collaborations and investments in cutting edge technologies. Over ten value-creating acquisitions and business development deals in the past two years have reshaped our footprint in oncology, expanding our capacities with leading talent, as well as state-of-the-art molecules and technologies in immuno-oncology, molecular oncology, and genomic medicine.”

Safety and efficacy data for tusamitamab ravtansine add to growing body of evidence for our potential first-in-class therapy for the treatment of nonsquamous non-small cell lung cancer (NSQ NSCLC) with CEACAM5 expression*

• Abstract 9039: Safety and efficacy of tusamitamab ravtansine (SAR408701) in long-term treated patients with NSQ NSCLC expressing carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5)

Early clinical data for Sarclisa^® (isatuximab-irfc) in combination with pomalidomide-dexamethasone highlight potential for subcutaneous administration by an on-body delivery system for the treatment of relapsed refractory multiple myeloma (RRMM) 

• Abstract 8025: Subcutaneous (SC) isatuximab administration by an on-body delivery system (OBDS) in combination with pomalidomide-dexamethasone (Pd) in patients with RRMM: Interim phase 1b study results

Updates on trials for amcenestrant, an oral selective estrogen receptor degrader (SERD), for the potential treatment of breast cancer*

• Abstract TPS607: Adjuvant study of amcenestrant (SAR439859) versus tamoxifen for patients with hormone receptor-positive (HR+) early breast cancer (EBC), who have discontinued adjuvant aromatase inhibitor therapy due to treatment-related toxicity (AMEERA-6)
• Abstract 528: AMEERA-4: A preoperative window-of-opportunity (WOO) study to assess the pharmacodynamic (PD) activity of amcenestrant or letrozole in postmenopausal patients with ER+/HER2- primary breast cancer

Biomarker research for SAR444881, a potential first-in-class anti-ILT2 monoclonal antibody*

• Abstract 2571: Evaluation of pharmacodynamic and patient enrichment biomarkers for SAR444881, a first-in-class anti-ILT2 monoclonal antibody for cancer immunotherapy

Trial in progress for investigational use of Libtayo^® (cemiplimab-rwlc) in patients with high-risk cutaneous squamous cell carcinoma (CSCC)

• Abstract TPS9592: C-POST protocol update: A Phase 3, randomized, double-blind study of adjuvant cemiplimab versus placebo post surgery and radiation therapy (RT) in patients with high-risk CSCC

Libtayo is being jointly developed by Sanofi and Regeneron under a global collaboration agreement.

Safety and efficacy data for SAR439459, a transforming growth factor beta (TGF-β) inhibitor*

• Abstract 2524: Safety and efficacy results from the expansion phase of the first-in-human study evaluating TGFβ inhibitor SAR439459 alone and combined with cemiplimab in adults with advanced solid tumors

Immunogenomic analysis for IL-2-based immunotherapies*

• Publication Only: Detailed immunogenomic analysis of high dose IL-2 pharmacodynamic effects: A benchmark for next-generation IL-2-based immunotherapies

Health economics and outcomes research in NSCLC

• Publication Only: Insights into the advanced non-small cell lung cancer patient journey: Treatment decision-making, preferences, and quality of life considerations

Click here to view these abstracts located in the ASCO Meeting Library.

*These assets are currently under investigation and their safety and efficacy has not been fully evaluated by any health authority.

IMPORTANT SAFETY INFORMATION AND INDICATION FOR U.S. PATIENTS

What is SARCLISA?

SARCLISA is a prescription medicine used in combination with:

• The medicines pomalidomide and dexamethasone, to treat adults who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor to treat multiple myeloma.
• The medicines carfilzomib and dexamethasone, to treat adults with multiple myeloma who have already received 1 to 3 lines of treatment and they did not work or are no longer working.

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

Important Safety Information

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

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

• Have heart problems, if your healthcare provider prescribes SARCLISA in combination with carfilzomib and dexamethasone for 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. Especially tell your healthcare provider if you have ever taken a medicine for your heart.

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 either the medicines pomalidomide and dexamethasone, or carfilzomib and dexamethasone.
  • In cycle 1, SARCLISA is usually given weekly.
  • Starting in cycle 2, SARCLISA is usually given every 2 weeks.
• 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 or life threatening.
  • 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.

Get medical help right away if you develop any of the following symptoms of infusion reaction during or after an infusion of SARCLISA:

—  shortness of breath, wheezing, or trouble breathing
—  swelling of the face, mouth, throat, or tongue
—  throat tightness
—  palpitations
—  dizziness, lightheadedness, or fainting
—  headache
—  cough
—  rash or itching
—  nausea
—  runny or stuffy nose
—  chills

• 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 tract infections and urinary tract 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.
   
• Heart failure. Heart failure can happen during treatment with SARCLISA in combination with carfilzomib and dexamethasone. Tell your healthcare provider right away if you develop any of the following symptoms:
  • trouble breathing
  • cough
  • swelling of your ankles, feet or legs

The most common side effects of SARCLISA in combination with pomalidomide and dexamethasone include:

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

The most common side effects of SARCLISA in combination with carfilzomib and dexamethasone include:

• upper respiratory tract infection
• tiredness and weakness
• high blood pressure
• diarrhea
• lung infection (pneumonia)
• trouble breathing
• trouble sleeping
• bronchitis
• cough
• back pain
• decreased red blood cells (anemia)
• decreased platelet counts (thrombocytopenia)           

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.

IMPORTANT SAFETY INFORMATION AND INDICATION 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.

LIBTAYO is a prescription medicine used to treat people with a type of skin cancer called basal cell carcinoma that cannot be removed by surgery (locally advanced BCC) and have received treatment with a hedgehog pathway inhibitor (HHI) or cannot receive treatment with an HHI.

LIBTAYO is a prescription medicine used to treat people with a type of lung cancer called non–small cell lung cancer (NSCLC). LIBTAYO may be used as your first treatment when your lung cancer has not spread outside your chest (locally advanced lung cancer) and you cannot have surgery or chemotherapy with radiation, or your lung cancer has spread to other areas of your body (metastatic lung cancer), and your tumor tests positive for high “PD-L1,” and your tumor does not have an abnormal “EGFR,” “ALK,” or “ROS1” gene.

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 certain cancers 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. You can have more than one of these problems at the same time. 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 new or worsening signs or symptoms, including:

• Lung problems: cough, shortness of breath, or chest pain
• Intestinal problems: diarrhea (loose stools) or more frequent bowel movements than usual, stools that are black, tarry, sticky or have blood or mucus, or severe stomach-area (abdomen) pain or tenderness
• Liver problems: yellowing of your skin or the whites of your eyes, severe nausea or vomiting, pain on the right side of your stomach area (abdomen), dark urine (tea colored), or bleeding or bruising more easily than normal
• Hormone gland problems: headache that will not go away or unusual headaches, eye sensitivity to light, eye problems, rapid heartbeat, increased sweating, extreme tiredness, weight gain or weight loss, feeling more hungry or thirsty than usual, urinating more often than usual, hair loss, feeling cold, constipation, your voice gets deeper, dizziness or fainting, or changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness
• Kidney problems: decrease in your amount of urine, blood in your urine, swelling of your ankles, or loss of appetite
• Skin problems: rash, itching, skin blistering or peeling, painful sores or ulcers in mouth or nose, throat, or genital area, fever or flu-like symptoms, or swollen lymph nodes
• Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with LIBTAYO. Call or see your healthcare provider right away for any new or worsening signs or symptoms, which may include: chest pain, irregular heartbeat, shortness of breath or swelling of ankles, confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs, double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight, persistent or severe muscle pain or weakness, muscle cramps, low red blood cells, or bruising
• Infusion reactions that can sometimes be severe. Signs and symptoms of infusion reactions may include: nausea, chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, feel like passing out, fever, back or neck pain, or facial swelling
• Rejection of a transplanted organ. Your healthcare provider should tell you what signs and symptoms you should report and monitor you, depending on the type of organ transplant that you have had
• Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with LIBTAYO. Your healthcare provider will monitor you for these complications

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 also need to delay or completely stop treatment with LIBTAYO 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 received an organ transplant
• have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
• have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
• 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 muscle or bone pain, 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.

About Sanofi
We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.

Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY

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