- Oral presentation to highlight results of a first-in-human study of an investigational trifunctional anti-CD123 NK cell engager SAR443579, which was recently granted Fast Track Designation by the U.S. FDA for the treatment of hematological malignancies
- Sanofi continues to advance its research into potentially transformative therapies such as antibody drug conjugates, natural killer and T-cell therapeutics
Paris, June 2, 2023. Sanofi will present new data at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting from June 2-6, including an oral presentation where results will be shared for the first time of a first-in-human study of an investigational trifunctional anti-CD123 natural killer (NK) cell engager SAR443579 in relapsed or refractory acute myeloid leukemia, B-cell acute lymphoblastic leukemia or high risk-myelodysplasia.
Peter Adamson
Global Development Head, Oncology
“The presentation of data at ASCO from our initial clinical trial of SAR443579, a novel NK cell engager, supports the potential of this investigational approach for patients with hematologic malignancies. At Sanofi, we are continuing to build our early oncology pipeline, which leverages leading-edge R&D platforms, to drive a range of investigational approaches for patients with difficult-to-treat cancers.”
The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for SAR443579 for the treatment of hematological malignancies. Fast Track Designation is an FDA process designed to facilitate the development, and expedite the review of, medicines to treat serious conditions and fill unmet medical need. The FDA created this process to help deliver important new drugs to patients earlier, and it covers a broad range of serious illnesses.
Olivier Nataf
Global Head, Oncology
“Having recently joined Sanofi as Global Head, Oncology, I am looking forward to coming together with the global oncology community at ASCO to discuss the future of cancer treatment and latest oncology research. This year, we are focused on highlighting our pipeline and exploring new opportunities that allow us to continue helping those living with cancer. Cancer is complex and we understand that innovation does not happen in isolation, so exploring strategic partnerships and collaborations that align science and technology with evolving medical needs is essential to our journey.”
Sanofi’s oncology pipeline has doubled since 2019, and we are exploring the advancement of potentially transformative therapies and focusing research on areas of high unmet needs for those living with various types of cancer.
Other Sanofi data to be presented at ASCO include studies in several priority areas of focus, such as relapsed multiple myeloma, advanced solid tumors and non-small cell lung cancer.
Early data for SAR443579, an investigational trifunctional anti-CD123 NK cell engager*
Abstract #7005: A first-in-human study of CD123 NK Cell Engager SAR443579 in relapsed or refractory acute myeloid leukemia, B-cell acute lymphoblastic leukemia or high risk-myelodysplasia
Updated results of the Phase 3 IKEMA study of Sarclisa® (isatuximab) in relapsed multiple myeloma
Abstract #8029: Long-term outcomes with isatuximab-carfilzomib-dexamethasone (Isa-Kd) in relapsed multiple myeloma patients with 1q21+ status: updated results from the Phase 3 IKEMA study
Early safety results of investigational tusamitamab ravtansine in advanced solid tumors*
Abstract #e15003: Phase 1/2 study of tusamitamab ravtansine in patients with advanced solid tumors: pooled safety analysis of corneal adverse events
Analysis of extended adjuvant endocrine therapy in HR+/HER2- breast cancer
Abstract #e12509: Side effects and impacts of extended adjuvant endocrine therapy: A qualitative study among women with HR+/HER2- breast cancer
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.
- Have had shingles (herpes zoster)
- 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.
- 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.
- 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 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.
The most common side effects of SARCLISA in combination with pomalidomide and dexamethasone include:
- upper respiratory tract infection
- lung infection (pneumonia)
- diarrhea
- decreased red blood cell count (anemia)
- decreased platelet count (thrombocytopenia)
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 cell count (anemia)
- decreased platelet count (thrombocytopenia)
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
These are not all the possible side effects of SARCLISA. For more information, ask your healthcare provider or pharmacist.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see full Prescribing Information, including Patient Information.
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
Media Relations
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Investor Relations
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Corentine Driancourt | + 33 6 40 56 92 21 | corentine.driancourt@sanofi.com
Felix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.com
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Nathalie Pham | + 33 7 85 93 30 17 | nathalie.pham@sanofi.com
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