CAMBRIDGE, Mass., May 15, 2019 /PRNewswire/ -- Sanofi's oncology franchise and robust pipeline will be featured at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting, delivering against a renewed strategy to address difficult-to-treat and difficult-to-eradicate cancers, including certain types of multiple myeloma, skin cancer, breast cancer, and lung cancer.
Four key molecules in clinical development are the pillars of Sanofi's late-stage and emerging oncology pipeline: isatuximab, an investigational anti-CD38 monoclonal antibody; Libtayo (cemiplimab), a PD-1 checkpoint inhibitor in development with Regeneron; SAR439859, an investigational oral selective estrogen receptor degrader (SERD); and SAR408701, an investigational anti-CEACAM5 antibody drug conjugate.
"We have a strategic focus to address unmet patient needs across many therapeutic areas at Sanofi, and currently oncology makes up a sizeable portion of our late-stage pipeline," said John Reed, Head of Research and Development at Sanofi. "Our oncology pipeline is flourishing, offering a progressively expanding diversity of opportunities to help advance the treatment of a variety of cancers. We are excited to showcase this progress at ASCO."
Positive results in relapsed/refractory multiple myeloma
Reed continued, "We are particularly excited to share the results from our pivotal Phase 3 ICARIA-MM trial of isatuximab in patients with a difficult-to-treat relapse/refractory multiple myeloma. This is the first of multiple Phase 3 trials with isatuximab, our wholly-owned molecule under investigation for the treatment of multiple myeloma. We look forward to the presentation of data at ASCO and believe that the ICARIA-MM data serve as the basis for the first regulatory filings of isatuximab."
Growing body of evidence in advanced cutaneous squamous cell carcinoma
Cutaneous squamous cell carcinoma (CSCC) is one of the most commonly diagnosed skin cancers worldwide. Although the majority of patients with CSCC have a good prognosis when the cancer is found early, the cancer can be especially difficult to treat when it progresses to advanced stages.i-v New longer-term data with Libtayo offer updated efficacy and safety outcomes that add to the growing body of evidence for Libtayo in patients with metastatic CSCC or locally advanced CSCC who are not candidates for curative surgery or curative radiation. Libtayo is being jointly developed by Regeneron and Sanofi under a global collaboration agreement.
Evolving evidence in breast and lung cancers
Breast cancer is the second most common form of cancer. An estimated 70% of breast cancers are estrogen receptor (ER) positive. SAR439859 is an investigational oral selective estrogen receptor degrader (SERD), a small molecule targeted therapy that binds to estrogen receptors in breast cancer cells to trigger their degradation.
Carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) is a cell-surface glycoprotein highly expressed in several tumor types, including non-squamous non-small cell lung cancer (NSQ NSCLC). Approximately 20% of lung cancers have a high expression of CEACAM5.
Additional abstracts supported by Sanofi include:
Oral Abstract, Friday, May 31, 2:45-5:45 PM
Updated results from a randomized phase II study of cabazitaxel
Poster Session, Saturday, June 1, 1:15-4:15 PM
Cell-free DNA as a biomarker for taxane treatment in advanced
Cabazitaxel with Abiraterone Versus Abiraterone Alone
HSD3B1 and Overall Survival in Men with Low-Volume Metastatic
CALGB 90203 (Alliance): Radical prostatectomy (RP) with or
Oral Abstract, Saturday, June 1, 3:00-6:00 PM
Association of Colon Cancer (CC) Molecular Signatures with
Clinical Science Symposium, Sunday, June 2, 8:00-9:00 AM
Evolutionary action score of TP53 analysis in pathologically high-
Poster Session, Monday, June 3, 8:00-11:00 AM
Repeated centralized MDT resectability assessment during first-line
Combination of tissues analysis and immune infiltrate in localized
Relative Contribution of Clinical and Molecular Features to
Is the predictive and prognostic impact of sporadic and familial
Isatuximab is an investigational anti-CD38 monoclonal antibody (mAb) for the treatment of patients with relapsed/refractory multiple myeloma. Developed by Sanofi, isatuximab targets a specific epitope of CD38 capable of triggering multiple, distinct mechanisms of action that are believed to promote programmed tumor cell death (apoptosis) and immunomodulatory activity. CD38 is highly and uniformly expressed on multiple myeloma cells and is a cell surface receptor target for antibody-based therapeutics in multiple myeloma and other malignancies. The clinical significance of these findings is under investigation.
Isatuximab is currently being evaluated in multiple ongoing Phase 3 clinical trials in combination with currently available treatments across the multiple myeloma treatment continuum. Isatuximab is also under investigation for the treatment of other hematologic malignancies and solid tumors. Isatuximab is an investigational agent and its safety and efficacy have not been evaluated by the U.S. Food and Drug Administration, the European Medicines Agency, or any other regulatory authority.
Libtayo is approved in the U.S., Canada and Brazil, and is under review by the European Commission following a positive opinion by the Committee for Medicinal Products for Human Use (CHMP). 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.vi The generic name for Libtayo in the U.S. 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.
Libtayo is also being investigated in potential registrational trials in non-small cell lung cancer, basal cell carcinoma and cervical cancer, along with additional trials in squamous cell carcinoma of the head and neck, melanoma, colorectal cancer, prostate cancer, multiple myeloma, Hodgkin's lymphoma and non-Hodgkin's lymphoma. These trials are designed to investigate Libtayo as monotherapy; in combination with conventional treatments like chemotherapy; or in combination with other investigational agents, including vaccines, oncolytic viruses and bispecific antibodies, among others. These potential uses are investigational, and their safety and efficacy have not been evaluated by any regulatory authority.
IMPORTANT SAFETY INFORMATION AND INDICATION FOR U.S. PATIENTS
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:
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.
Please see accompanying full Prescribing Information, including Medication Guide.
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.
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i Stratigos, Alexander et al. Diagnosis and treatment of invasive squamous cell carcinoma of the skin: European consensus-based interdisciplinary guideline. European Journal of Cancer, Vol 51(14);14, 1989-2007
ii Califano JA, Lydiatt WM, Nehal KS, et al. Cutaneous squamous cell carcinoma of the head and neck. In: Amin MB, Edge SB, Greene FL, et al, eds. AJCC Cancer Staging Manual. 8th ed. Springer; 2017:171-181.
iii Skin cancer treatment (PDQ®). National Cancer Institute website. https://www.cancer.gov/types/skin/hp/skin-treatment-pdq. Updated February 1, 2018. Accessed February 13, 2018.
iv Jennings L, Schmults CD. Management of high-risk cutaneous squamous cell carcinoma. J Clin Aesthet Dermatol. 2010;3(4):39-48.
v Brunner M, Veness MJ, Ch'ng S, Elliott M, Clark JR. Distant metastases from cutaneous squamous cell carcinoma—analysis of AJCC stage IV. Head Neck. 2013;35(1):72-75.
vi LIBTAYO® (cemiplimab-rwlc) full US Prescribing Information. Regeneron Pharmaceuticals, Inc. / sanofi-aventis U.S. LLC.