On May 16, 2019 Sanofi and Regeneron Pharmaceuticals, Inc. reported that positive updated data for Libtayo (cemiplimab-rwlc) in locally advanced and metastatic cutaneous squamous cell carcinoma (CSCC) will be shared at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from May 31 to June 4 in Chicago (Press release, Sanofi Genzyme, MAY 16, 2019, View Source [SID1234536428]). Libtayo is a fully-human monoclonal antibody targeting the immune checkpoint receptor PD-1 and is the first and only treatment approved and available for patients with metastatic CSCC or locally advanced CSCC who are not candidates for curative surgery or curative radiation in the U.S.
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These data from the pivotal Phase 2 EMPOWER-CSCC-1 trial include the primary analysis for the locally advanced CSCC group and longer-term data from the metastatic CSCC group. Together, they provide updated Libtayo efficacy and safety outcomes following its approval by the U.S. Food and Drug Administration (FDA) in September 2018 and will be shared alongside two additional joint Sanofi and Regeneron abstracts on CSCC.
Key data from EMPOWER-CSCC-1 published online in advance of ASCO (Free ASCO Whitepaper) include:
Locally Advanced CSCC
(n=78a)
Metastatic CSCC
(n=59b)
Median follow upa
9 months
(Range: 1 to 28 months)
17 months
(Range: 1 to 27 months)
Overall response rated
(n; 95% confidence interval [CI])
44%
(34; 32%, 55%)
49%
(29; 36%, 63%)
Complete responsed
13% (10)
17% (10)
Partial responsed
31% (24)
32% (19)
Median duration of response (DOR)
Not yet reached
Not yet reached
Median observed time to response
2 months
(Range: 2 to 9 months)
2 months
(Range: 2 to 9 months)
Durable disease control rate (DCR) of ≥16 weekse
63%
(95% CI: 51% to 74%)
63%
(95% CI: 49% to 75%)
Median progression free survival
Not yet reached
18 months
(95% CI: 7 months to not evaluable)
Median overall survival
Not yet reached
Not yet reached
a October 10, 2018 data cutoff
b September 20, 2018 data cutoff
c Excluding survival follow-up
d As assessed by central review
e Durable DCR includes stable disease or response
Among patients with locally advanced CSCC, the most common adverse events (AEs) were fatigue (42%), diarrhea and pruritus (both 27%) and nausea (22%). Grade 3 or higher immune-related AEs occurred in 10% of patients; one patient died due to an unknown cause assessed as treatment-related. Among patients with metastatic CSCC, the most common AEs were diarrhea (29%), fatigue (25%) and nausea (24%). Investigator-assessed Grade 3 or higher immune-related AEs occurred in 14% of patients.
In addition to the EMPOWER-CSCC-1 data, Sanofi and Regeneron are also sharing results from the largest retrospective data set of patients with metastatic or locally advanced CSCC who were treated with chemotherapy or an EGFR (epidermal growth factor receptor) inhibitor but who did not receive anti-PD-1 or anti-PD-L1 therapy.
Sanofi and Regeneron joint presentations at ASCO (Free ASCO Whitepaper) include:
Poster Discussion & Poster Sessions
Primary analysis of Phase 2 results of cemiplimab, a human monoclonal anti-PD-1, in patients with locally advanced cutaneous squamous cell carcinoma (Dr. Michael Migden; Saturday, June 1; Poster Display: 1:15-4:15 PM; Poster Discussion: 4:30-6:00 PM)
Phase 2 study of cemiplimab, a human monoclonal anti-PD-1, in patients with metastatic cutaneous squamous cell carcinoma (mCSCC; Group 1): 12 month follow-up (Dr. Alexander Guminski; Monday, June 3; Poster Display: 1:15-4:15 PM)
Publication-Only Abstracts
Treatment patterns and outcomes among patients with advanced cutaneous squamous cell carcinoma in a US community oncology setting (Dr. C. Lance Cowey; Publication Only)
Patterns of major surgeries among patients diagnosed with cutaneous squamous cell carcinoma (Chieh-I Chen; Publication Only)
Libtayo is being jointly developed by Sanofi and Regeneron under a global collaboration agreement.
About CSCC
CSCC is the second most common type of skin cancer in the world, accounting for approximately 20% of all skin cancers, and the number of newly diagnosed cases is expected to rise substantially in many countries. Although CSCC has a good prognosis when caught early, the cancer can prove especially difficult to treat effectively when it is advanced, and patients can experience reduced quality of life due to the impact of the disease as it progresses. Advanced CSCC is the deadliest non-melanoma skin cancer. While estimates vary, sources suggest that 7,000 people in the U.S. die annually of advanced CSCC.
About Libtayo
Libtayo is approved in the U.S., Canada and Brazil, and 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. 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. FDA.
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:
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.