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Libtayo® (cemiplimab-rwlc) Data Provide New Insights in Six Tumor Types Under Investigation

Regeneron Pharmaceuticals, Inc. and Sanofi will present a diverse set of data from their joint clinical program investigating Libtayo® (cemiplimab-rwlc) at the ESMO 2018 Congress (European Society for Medical Oncology) from October 19 to 23 in Munich, Germany.

These data span six different tumor types, including non-small cell lung cancer (NSCLC), cervical cancer, cutaneous squamous cell carcinoma (CSCC), hepatocellular carcinoma (HCC), head and neck squamous cell carcinoma (HNSCC) and basal cell carcinoma (BCC). Libtayo is a fully-human monoclonal antibody targeting the immune checkpoint receptor PD-1 (programmed cell death protein-1).

"Following the U.S. FDA approval of Libtayo in advanced CSCC, we remain focused on pursuing science that has the potential to change treatment paradigms in oncology," said Israel Lowy, M.D., Ph.D., Vice President of Global Clinical Development and Head of Translational Science and Clinical Oncology, Regeneron. "At ESMO, we look forward to sharing new data that support our rationale for pursuing registrational trials of Libtayo in lung, cervical and skin cancers."

All six of the abstracts accepted at ESMO focus on ongoing Libtayo clinical trials.

"Three years ago, Sanofi began its immuno-oncology collaboration with Regeneron with the shared vision to address significant unmet needs across various cancer types," said Joanne Lager, M.D., Head of Oncology Development, Sanofi. "This year's data being presented at ESMO are a testament to our commitment to patients and the potential to make our vision a reality."

Among the joint Regeneron and Sanofi presentations are new clinical data from a Phase 1 expansion cohort investigating Libtayo in combination with radiotherapy in advanced NSCLC as well as longer-term follow-up data from the advanced CSCC expansion cohorts in the Phase 1 trial. Additional abstracts will feature initial data from Phase 1 expansion cohorts investigating Libtayo in cervical cancer, HCC and HNSCC, alongside a trial-in-progress update on the potentially pivotal Phase 2 trial in BCC.

Regeneron and Sanofi joint presentations at ESMO include:

  • Cemiplimab, a human PD-1 monoclonal antibody, in patients with recurrent or metastatic cervical cancer: Interim data from phase 1 cohortsDanny Rischin Oct 20/12:30-13:30/958P
  • Cemiplimab, a human monoclonal anti-PD-1, plus radiotherapy in advanced non-small cell lung cancer (NSCLC): Results from a Phase 1 expansion cohort (EC 2)Victor Moreno, Oct 20/12:30-13:30/1162P
  • Phase 1 study of cemiplimab, a human monoclonal anti-PD-1, in patients with unresectable locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC): Longer follow-up efficacy and safety dataTaofeek K. Owonikoko, Oct 21/12:45-13:45/1292P
  • Cemiplimab, a human monoclonal anti-PD-1, in patients with advanced or metastatic hepatocellular carcinoma (HCC): Data from an expansion cohort in a Phase 1 studyMichael J. Pishvaian, Oct 20/12:30-13:30/1151P
  • Phase 1 expansion cohort results of cemiplimab, a human PD-1 monoclonal antibody, in combination with radiotherapy, cyclophosphamide and GM-CSF, in patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC)Hani Babiker, Oct 20/12:30-13:30/1171P
  • Phase 2 study of cemiplimab, a human monoclonal anti-PD-1, in patients with advanced basal cell carcinoma (BCC) who experienced progression of disease on, or were intolerant of prior hedgehog pathway inhibitor therapy Karl D. Lewis, Oct 20/12:30-13:30/1240TiP

Libtayo is being developed jointly by Regeneron and Sanofi under a global collaboration agreement, and was invented by Regeneron using the company's proprietary VelocImmune® technology that yields optimized fully-human antibodies. The potential uses of Libtayo as a treatment for NSCLC, cervical cancer, BCC, HCC and HNSCC are investigational, and its safety and efficacy have not been evaluated by any regulatory authority for these cancers.

Libtayo is currently approved in the U.S. for the treatment of patients with metastatic CSCC or locally advanced CSCC who are not candidates for curative surgery or curative radiation. 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. Regeneron and Sanofi Genzyme, the specialty care global business unit of Sanofi, market Libtayo jointly in the U.S. The safety and efficacy of Libtayo have not been evaluated by any regulatory authority outside of the U.S. for the treatment of advanced CSCC.

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:

  • Lung problems (pneumonitis). Signs and symptoms of pneumonitis may include new or worsening cough, shortness of breath, and chest pain.
  • Intestinal problems (colitis) that can lead to tears or holes in your intestine. Signs and symptoms of colitis may include diarrhea (loose stools) or more frequent bowel movements than usual; stools that are black, tarry, sticky or that have blood or mucus; and severe stomach-area (abdomen) pain or tenderness.
  • Liver problems (hepatitis). Signs and symptoms of hepatitis may include yellowing of your skin or the whites of your eyes, severe nausea or vomiting, pain on the right side of your stomach area (abdomen), drowsiness, dark urine (tea colored), bleeding or bruising more easily than normal, and feeling less hungry than usual.
  • Hormone gland problems (especially the adrenal glands, pituitary, thyroid and pancreas). Signs and symptoms that your hormone glands are not working properly may include headaches that will not go away or unusual headaches, rapid heartbeat, increased sweating, extreme tiredness, weight gain or weight loss, dizziness or fainting, feeling more hungry or thirsty than usual, hair loss, feeling cold, constipation, deeper voice, very low blood pressure, urinating more often than usual, nausea or vomiting, stomach-area (abdomen) pain, and changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness.
  • Kidney problems, including nephritis and kidney failure. Signs of these problems may include decrease in your amount of urine, blood in your urine, swelling in your ankles, and loss of appetite.
  • Skin problems. Signs of these problems may include rash, itching, skin blistering, and painful sores or ulcers in the mouth, nose, throat, or genital area.
  • Problems in other organs. Signs of these problems may include headache, tiredness or weakness, sleepiness, changes in heartbeat (such as beating fast, seeming to skip a beat, or a pounding sensation), confusion, fever, muscle weakness, balance problems, nausea, vomiting, stiff neck, memory problems, seizures (encephalitis), swollen lymph nodes, rash or tender lumps on skin, cough, shortness of breath, vision changes, or eye pain (sarcoidosis), seeing or hearing things that are not there (hallucinations), severe muscle weakness, low red blood cells (anemia), bruises on the skin or bleeding, and changes in eyesight.
  • Rejection of a transplanted organ. Your doctor should tell you what signs and symptoms you should report and monitor you, depending on the type of organ transplant that you have had.
  • Infusion (IV) reactions that can sometimes be severe and life-threatening. Signs of these problems may include chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, fever, feeling of passing out, back or neck pain, and facial swelling.

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:

  • have immune system problems such as Crohn's disease, ulcerative colitis, or lupus;
  • have had an organ transplant;
  • have lung or breathing problems;
  • have liver or kidney problems;
  • have diabetes;
  • are pregnant or plan to become pregnant; Libtayo can harm your unborn baby

    Females who are able to become pregnant:
    • Your healthcare provider will give you a pregnancy test before you start treatment.
    • You should use an effective method of birth control during your treatment and for at least 4 months after your last dose of Libtayo. Talk with your healthcare provider about birth control methods that you can use during this time.
    • Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Libtayo.
  • are breastfeeding or plan to breastfeed. It is not known if Libtayo passes into your breast milk. Do not breastfeed during treatment and for at least 4 months after the last dose of Libtayo.

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.

About Regeneron Pharmaceuticals, Inc.
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neuromuscular diseases, infectious diseases and rare diseases.

Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.


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