On September 3, 2020 Sanofi and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that will present new, positive data for PD-1 inhibitor Libtayo (cemiplimab) at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020 from September 19-21 (Press release, Sanofi, SEP 3, 2020, View Source [SID1234564443]). Among the accepted abstracts are two late-breaking oral presentations on the investigational use of Libtayo monotherapy in first-line advanced non-small cell lung cancer (NSCLC) and locally advanced basal cell carcinoma (BCC) previously treated with a hedgehog inhibitor.
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Additional presentations will include patient-reported quality-of-life and real-world patient data for Libtayo in advanced cutaneous squamous cell carcinoma (CSCC).
"The Libtayo clinical development program, as monotherapy or in combination with either conventional or novel therapies, focuses on the real-world challenges of patients confronting difficult-to-treat or rare cancers," said Peter Adamson, M.D., Global Development Head, Oncology and Pediatric Innovation at Sanofi. "This development approach was evidenced by the initial approval of Libtayo for patients with advanced cutaneous squamous cell carcinoma, and it continues to guide our Libtayo clinical development program for non-small cell lung cancer and basal cell carcinoma."
Late-breaking oral presentations include:
EMPOWER-Lung 1: Phase 3 first-line cemiplimab monotherapy vs platinum-doublet chemotherapy in advanced NSCLC with programmed cell death ligand-1 (PD-L1) ≥50% (Abstract 1158, LBA52; Ahmet Sezer, M.D.; Proffered Paper Presentation)
Primary analysis of Phase 2 results for cemiplimab in patients with locally advanced BCC who progress on or are intolerant to hedgehog inhibitors (HHIs) (Abstract 3933, LBA47; Alexander Stratigos, M.D.; Mini-oral Presentation)
"Libtayo monotherapy continues to demonstrate significant results in pivotal trials across diverse cancers, and we are excited to share these data at ESMO (Free ESMO Whitepaper)," said Israel Lowy, M.D., Ph.D., Senior Vice President, Translational and Clinical Sciences, Oncology, at Regeneron. "These trial outcomes highlight the potential of Libtayo to advance treatment of non-small cell lung cancer and basal cell carcinoma, and will form the basis for regulatory submissions in the U.S. and European Union."
Additional Libtayo presentations include:
Time to clinically meaningful changes in pain in patients with advanced CSCC treated with cemiplimab in a Phase 2 clinical trial (Abstract 3955; Poster 1087P; Michael Migden, M.D.; Poster Presentation)
Demographics, prior therapies and reasons for cemiplimab treatment: prospective CemiplimAb-rwlc Survivorship and Epidemiology (C.A.S.E.) study in patients with advanced CSCC (Abstract 1996; Poster 1094P; Guilherme Rabinowits, M.D.; Poster Presentation)
EMPOWER-Lung 4: Phase 2, randomized, open-label high dose or standard dose cemiplimab alone/plus ipilimumab in the second-line treatment of advanced NSCLC (Abstract 4033; Poster 1269P; Byoung Yong Shim, M.D.; Poster Presentation)
Libtayo is being jointly developed by Regeneron and Sanofi under a global collaboration agreement.
About Libtayo
Libtayo is a fully-human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T-cells. By binding to PD-1, Libtayo has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation.
Libtayo is the first immunotherapy approved in the U.S., EU, and other countries for adults with metastatic CSCC or locally advanced CSCC who are not candidates for curative surgery or curative radiation. In the U.S., the generic name for Libtayo in its approved indication 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 trials in adjuvant and neoadjuvant CSCC in addition to the pivotal trial in advanced BCC. Libtayo is also being investigated in pivotal trials in NSCLC and cervical cancer, as well as in trials combining Libtayo with either conventional or 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.
IMPORTANT SAFETY INFORMATION AND INDICATION 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. You can have more than one problem at the same time. 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 or persistent muscle pain, 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, diarrhea, muscle or bone pain, and nausea. 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.