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.
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.
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:
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:
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?
What are the possible side effects of SARCLISA?
SARCLISA may cause serious side effects, including:
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
— dizziness, lightheadedness, or fainting
— rash or itching
— runny or stuffy nose
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.
The most common side effects of SARCLISA in combination with pomalidomide and dexamethasone include:
The most common side effects of SARCLISA in combination with carfilzomib and dexamethasone include:
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:
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.
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.
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