Sanofi's emerging oncology pipeline highlighted at the AACR Virtual Annual Meeting II
"We believe the innovation and efforts we are driving in oncology have the potential to make a significant difference in the lives of people living with cancer," said
Preclinical data show anti-tumor activity and support further research across a range of solid tumors, including evolving evidence in breast and lung cancers
Abstract 3452: Pre-clinical development of next generation Selective Estrogen Receptor Degrader –
- Preclinical research from SERD '859 demonstrated anti-tumor activity in HR+ breast cancer cell lines.
- SERD '859 showed significant anti-tumor activity against endocrine-therapy-resistant, patient-derived tumor models that correlated with pharmacokinetic (PK) exposure and pharmacodynamic (PD) modulation in target tissue.
- Looking to potential combination therapies, researchers observed strong synergistic activity between SERD '859 and palbociclib, a CDK4/6 inhibitor
Abstract 561/16: Pre-clinical efficacy data for the anti-CEACAM5-DM4 ADC
- Results from patient-derived xenograft mouse studies of SAR '701 in non-small cell lung cancer will be presented.
- Findings revealed a potential correlation between preclinical activity of the compound and the expression of CEACAM5 in lung tumors.
- Further exploration of SAR '701 clinical activity is also ongoing across a number of CEACAM5-expressing solid tumors.
- Results from preclinical combination studies showed
SAR442720enhanced the anti-tumor activity of EGFR-mutant or KRASG12C inhibitors.
Preclinical data add to growing body of evidence supporting Sarclisa (isatuximab-irfc) in multiple myeloma and other blood cancers
Abstract 5179/5: Isatuximab based combinations induce potent tumor growth inhibition in pre-clinical models of multiple myeloma and acute lymphocytic leukemia (Dr.
Sarclisa is a monoclonal antibody that binds to the CD38 receptor on multiple myeloma cells. It is currently approved for use in the
- Results from a study using patient-derived mouse xenograft models showed anti-tumor activity with Sarclisa in combination with standard-of-care treatments in both multiple myeloma (pomalidomide, lenalidomide, bortezomid, carfilzomib, melphalan) and acute lymphocytic leukemia (vincristine, cytarabine, cyclophosphamide). These potential uses of Sarclisa are investigational, and their safety and efficacy have not been evaluated by any regulatory authority.
Early science: new approaches in blood cancer research
Abstract 2266/1: SAR442085, a next generation anti-CD38 antibody with enhanced antibody-dependent cellular cytotoxicity (ADCC) against multiple myeloma (Dr.
Current anti-CD38 treatments in combination with standard treatments represent a major advancement in the treatment of patients with relapsed and refractory multiple myeloma, but unmet needs remain. Sanofi scientists investigating a next-generation anti-CD38 antibody SAR442085 for the treatment of multiple myeloma will present preclinical data at the meeting.
- Findings from a study of SAR442085 include antibody-dependent cellular cytotoxicity activity in vivo compared to currently available anti-CD38 antibodies.
- SAR442085 demonstrated a higher level of natural killer (NK) cell activation against primary plasma cells in patient samples and potent in vivo single-agent activity against tumor cells expressing human CD38 in a C57BL/6 mouse model.
- SAR442085 is currently being evaluated in Phase I clinical trials in patients with relapsed/refractory multiple myeloma.
Abstract 5641/2: CD28 expression on multiple myeloma cells enhances the cytotoxic activity of CD38/CD28xCD3 trispecific T-cell engager (Dr.
- Preclinical data show that
SAR442257is active on CD38 in multiple myeloma models.
SAR442257can also directly target CD28, a T-cell activating protein expressed on tumor cells, enhancing the protein's anti-tumor activity and allowing it to bind to tumor cells when CD38 is occupied by other antibodies.
The clinical significance of the preclinical findings relating to SERD '859, SAR '701,
Sarclisa is a monoclonal antibody that binds to a specific epitope on the CD38 receptor on MM cells. It is designed to work through multiple mechanisms of action including programmed tumor cell death (apoptosis) and immunomodulatory activity. CD38 is highly and uniformly expressed on the surface of MM cells, making it a potential target for antibody-based therapeutics such as Sarclisa.
Sarclisa is approved in the EU,
Sarclisa continues to be evaluated in multiple ongoing Phase 3 clinical trials in combination with current standard treatments across the MM treatment continuum. It is also under investigation for the treatment of other hematologic malignancies and solid tumors. The safety and efficacy of these additional uses have not been evaluated by any regulatory authority.
For more information on Sarclisa clinical trials please visit www.clinicaltrials.gov.
IMPORTANT SAFETY INFORMATION AND INDICATION FOR
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)
-upper respiratory tract infection
-decreased red blood cell counts
-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.
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