Libtayo (cemiplimab-rwlc) Data at ESMO 2018 Congress Provide New Insights in Six Tumor Types Under Investigation
ESMO data demonstrate breadth of joint Regeneron and Sanofi immuno-oncology development program- ESMO presentations follow the recent U.S. FDA approval of Libtayo for patients with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) who are not candidates for curative surgery or curative radiation
TARRYTOWN, N.Y. and PARIS,? --?Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) 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 cohorts Danny 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 data Taofeek 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 study Michael 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
- 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.
- 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.
Regeneron Contacts: | Sanofi Contacts: |
Media Relations Daren Kwok Tel: +1 (914) 847-1328 daren.kwok@regeneron.com | Media Relations Ashleigh Koss Tel: +1 (908) 981-8745 ashleigh.koss@sanofi.com |
Investor Relations Manisha Narasimhan, Ph.D. Tel: +1 (914) 847-5126 manisha.narasimhan@regeneron.com | Investor Relations George Grofik Tel: +33 (0)1 53 77 45 45 ir@sanofi.com |
View original content:http://www.prnewswire.com/news-releases/libtayo-cemiplimab-rwlc-data-at-esmo-2018-congress-provide-new-insights-in-six-tumor-types-under-investigation-300727269.html
SOURCE Regeneron Pharmaceuticals, Inc.