- Clinical data to be presented for Sarclisa (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 Sarclisa (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?
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
- 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)
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.
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.
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.
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