CAMBRIDGE, Mass., May 13, 2020 /PRNewswire/ -- Sanofi will present data from across its oncology franchise, including portfolio and pipeline compounds, during the upcoming American Society of Clinical Oncology (ASCO) Virtual Scientific Program from May 29-31. Among the abstracts are new research highlighting the company's leadership and commitment to the care of patients with non-melanoma skin cancer, prostate cancer, and multiple myeloma, and early stage clinical data for two potentially transformative therapies for breast and lung cancer.
"We are determined to improve the outcomes for patients with cancer by developing transformative therapies, and this is a pivotal time to continue our commitment to patients and the oncology community," said Dietmar Berger, Global Head of Clinical Development and Chief Medical Officer. "We are fortunate to have recently welcomed Dr. Peter C. Adamson to lead our Global Oncology Development team, and he will continue to oversee our emerging pipeline. We are at the forefront of translating scientific advances into potential new treatments in our pipeline, and focused on addressing critical gaps that may help advance the care of several difficult-to-treat cancers."
Early-stage clinical results support innovative approaches in metastatic breast cancer and advanced non-small cell lung cancer
"Building upon advances in molecular- and immuno- oncology, our portfolio and pipeline strategy leverage leading-edge technology platforms to develop better therapies for patients with diverse malignancies including skin, blood, breast and lung cancers", said Peter C. Adamson, Global Development Head, Oncology and Pediatric Innovation. "We are leading the way with our investigational oral SERD that can serve as potential backbone treatment across multiple lines of therapy for patients with ER+ breast cancer, and our first-in-class investigational compound CEACAM5 antibody-drug conjugate for patients with lung cancer or potentially other CEACAM5-expressing solid tumors. We are excited to share early clinical and proof of concept data on both at the upcoming ASCO20 virtual meeting."
In the U.S., more than 154,000 women are estimated to have metastatic breast cancer (mBC)i and approximately 79% of breast cancers are estrogen receptor (ER) positive.ii SAR439859 is an investigational oral selective estrogen receptor degrader (SERD), a potential best-in-class small molecule targeted therapy that binds to ERs in breast cancer cells to inhibit ER signaling and trigger their degradation.
Non-small cell lung cancer (NSCLC) is the most common type of lung cancer and accounts for 84% of all diagnoses.iii CEACAM5 is a cell-surface glycoprotein highly expressed in several tumor types, including NSCLC. Approximately 20% of lung cancers have a high expression of CEACAM5. Data will be presented on our first-in-class CEACAM5 antibody-drug conjugate during an oral presentation at ASCO20.
Long-term data for Libtayo® (cemiplimab-rwlc) in advanced CSCC
Cutaneous squamous cell carcinoma (CSCC) is one of the most commonly diagnosed skin cancers worldwide, and although the majority of patients have a good prognosis when the cancer is discovered early, it can be especially difficult to treat successfully when it progresses to advanced stages.iv-v-vi-vii-viii New longer-term data from the pivotal Phase 2 study of Libtayo offer updated efficacy and safety outcomes that add to the most mature dataset for any therapy in advanced CSCC. In the U.S., Libtayo is approved for the treatment of patients with metastatic CSCC or locally advanced CSCC who are not candidates for curative surgery or curative radiation. Libtayo is a PD-1 immune checkpoint inhibitor being jointly developed with Regeneron under a global collaboration agreement.
Growing body of evidence in multiple myeloma and metastatic castration-resistant prostate cancer
Multiple myeloma (MM) is the second most common hematologic malignancy,ix and, despite available treatments, the disease is associated with significant patient burden. Results from a Phase 1b study evaluating Sarclisa® (isatuximab-irfc) in newly diagnosed MM patients who are ineligible for transplant add to a growing body of positive data. Sarclisa, a monoclonal antibody that binds to the CD38 receptor on MM cells, is approved for use in the U.S. in combination with pomalidomide and dexamethasone for the treatment of adults who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.
Prostate cancer is a very heterogenous disease and one of the most common types of cancer in men.x Metastatic castration-resistant prostate cancer (mCRPC) is prostate cancer that has spread beyond the prostate gland and progressed despite androgen deprivation therapy.xi Results from a post-hoc analysis of the CARD clinical trial highlight that overall survival was significantly longer with Jevtana® (cabazitaxel) versus abiraterone or enzalutamide in patients with mCRPC who had been previously treated with docetaxel and had disease progression within 12 months on a prior androgen receptor-targeted agent.
Additional research at ASCO20 Virtual Meeting supported by Sanofi include:
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
Real World Stem Cell Mobilization (PBSC) Patterns in MM Pts Receiving Autologous Transplant (ASCT)
Longitudinal Cumulative Dose: A Novel Measure to Assess Multiple Dimensions of Chemotherapy Adherence Over Time
Effectiveness of adjuvant FOLFOX vs 5FU for colon cancer treatment in community oncology practice using a hybrid study approach
Diagnostic accuracy of CT-staging of advanced gastric cancer following neoadjuvant chemotherapy.
Activity of cabazitaxel in patients with metastatic or inoperable locally advanced dedifferentiated liposarcoma. European Organization for Research and Treatment of Cancer (EORTC) Phase 2 trial 1202
Libtayo is approved in the U.S., EU, and other countries for adult patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. In the U.S., the generic name for Libtayo is cemiplimab-rwlc, with rwlc as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the U.S. Food and Drug Administration.
The extensive clinical program for Libtayo is focused on difficult-to-treat cancers. In skin cancer, this includes a potentially registrational Phase 2 trial in basal cell carcinoma, a Phase 3 trial in adjuvant setting in CSCC, and additional and neoadjuvant CSCC. . Libtayo is also being investigated in potentially registrational Phase 3 trials in non-small cell lung cancer and cervical cancer, as well as in trials combining Libtayo with novel therapeutic approaches for both solid tumors and blood cancers. These potential uses are investigational, and their safety and efficacy have not been evaluated by any regulatory authority.
Sarclisa is a monoclonal antibody that binds to the CD38 receptor on multiple myeloma cells. CD38 is highly and uniformly expressed on multiple myeloma cells and cell surface receptors, making it a target for antibody-based therapeutics such as Sarclisa. It is designed to induce programmed tumor cell death (apoptosis) and immunomodulatory activity.
Sarclisa is approved in the U.S. in combination with pomalidomide and dexamethasone for the treatment of adults with relapsed refractory multiple myeloma 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.
Sarclisa has also received a positive CHMP opinion in combination with pomalidomide and dexamethasone for the treatment of adults with relapsed and refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy. A final decision on the Marketing Authorisation Application for Sarclisa in the E.U. is expected in the coming months. The safety and efficacy of Sarclisa have not been fully evaluated by any regulatory authority outside of the U.S., Switzerland, Canada, and Australia.
Sarclisa continues to be evaluated in multiple ongoing Phase 3 clinical trials in combination with current standard treatments across the multiple myeloma treatment continuum. It is also under investigation for the treatment of other hematologic malignancies and solid tumors. These potential uses are investigational, and their safety and efficacy have not been evaluated by any regulatory authority.
About Jevtana (cabazitaxel)
Jevtana is a semi-synthetic taxane chemotherapy. Jevtana is a microtubule inhibitor that binds to tubulin and promotes its assembly into microtubules while simultaneously inhibiting disassembly. This leads to the stabilization of microtubules, which results in the inhibition of mitotic and interphase cellular functions.
Jevtana is indicated, in combination with prednisone, for the treatment of adult men with mCRPC previously treated with a docetaxel-containing treatment regimen.
IMPORTANT SAFETY INFORMATION AND INDICATIONS 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.
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 a type of skin cancer 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. 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 symptoms of the following problems or these symptoms get worse:
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 delay or completely stop treatment if you have severe side effects.
Before you receive Libtayo, tell your healthcare provider about all your medical conditions, including if you:
Females who are able to become pregnant:
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 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.
For more information, please see full Prescribing Information, including Medication Guide.
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:
Tell your healthcare provider right away if you think you are pregnant or become pregnant 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?
Your healthcare provider will decide how long you should receive SARCLISA.
What are the possible side effects of SARCLISA?
SARCLISA may cause serious side effects, including:
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:
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 include:
- lung infection (pneumonia)
- upper respiratory tract infection
- decreased red blood cell counts (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.
What is JEVTANA?
JEVTANA is a prescription medicine used with the steroid medicine prednisone. JEVTANA is used to treat men with castration-resistant prostate cancer (prostate cancer that is resistant to medical or surgical treatments that lower testosterone) that has spread to other parts of the body, and that has worsened (progressed) after treatment with other medicines that included docetaxel.
It is not known if JEVTANA is safe and effective in children.
What is the most important information I should know about JEVTANA?
JEVTANA may cause serious side effects, including:
Tell your HCP right away if you have any of these symptoms of infection during treatment with JEVTANA: fever (take your temperature often during treatment with JEVTANA), cough, burning during urination, or muscle aches.
Also, tell your HCP if you have any diarrhea during the time that your white blood cell count is low. Your HCP may prescribe treatment for you as needed.
Tell your HCP right away if you have any of these symptoms of a severe allergic reaction during or soon after an infusion of JEVTANA: rash or itching, skin redness, feeling dizzy or faint, breathing problems, chest or throat tightness, or swelling of face.
Who should not receive JEVTANA?
Do not receive JEVTANA if: your white blood cell (neutrophil count) is too low, you have had a severe allergic reaction to cabazitaxel or other medicines that contain polysorbate 80 (ask your HCP if you are not sure), you have severe liver problems..
What should I tell my HCP before receiving JEVTANA?
Before receiving JEVTANA, tell your HCP if you:
JEVTANA may cause fertility problems in males. This may affect your ability to father a child. Talk to your HCP if you have concerns about fertility.
Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. JEVTANA can interact with many other medicines. Do not take any new medicines without asking your HCP first. Your HCP will tell you if it is safe to take the new medicine with JEVTANA.
What are the most common side effects of JEVTANA?
The most common side effects of JEVTANA include:
- low red blood cell count (anemia), which is common with JEVTANA, but can sometimes also be serious. Your HCP will regularly check your red blood cell count. Symptoms of anemia include shortness of breath and tiredness.
- low blood platelet count, which is common with JEVTANA, but can sometimes also be serious. Tell your HCP if you have any unusual bruising or bleeding.
- Back pain
- Change in your sense of appetite
- decreased appetite
- shortness of breath
- hair loss
- numbness, tingling, burning or decreased sensation
- Stomach (abdominal) pain
Tell your HCP if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of JEVTANA. For more information, ask your HCP or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Please see full Prescribing Information/Patient Information, including Serious Side Effects.
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i Metastatic Breast Cancer Introduction. Susan G. Komen website. https://ww5.komen.org/BreastCancer/MetastaticBreastCancerIntroduction.html. Accessed April 17, 2020.
ii Li Y, et al. Clinicopathology Characteristics and Breast Cancer-Specific Survival of Patients with Single Hormone Receptor-Positive Breast Cancer. JAMA Netw Open. 2020;3(1):e1918160.
iii Lung Cancer – Non Small Cell: Statistics. Cancer.net. https://www.cancer.net/cancer-types/lung-cancer-non-small-cell/statistics. Accessed April 17, 2020.
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ix Kazandjian. Multiple myeloma epidemiology and survival: A unique malignancy. Semin Oncol. 2016;43(6):676-681. doi:10.1053/j/seminoncol.2016.11.004.
x Boyd LK, Mao X, Lu YJ. The complexity of prostate cancer: genomic alterations and heterogeneity. Nat Rev Urol. 2012 Nov;9(11):652-64. https://www.ncbi.nlm.nih.gov/pubmed/23132303.
xi Saad F, Hotte S. Guidelines for the management of castrate-resistant prostate cancer. Can Urol Assoc J 2010;4(6):380-4. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2997826/pdf/cuaj-6-380.pdf.