On September 4, 2022 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that new and updated data across its oncology pipeline will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022 from September 9 to 13 in Paris (Press release, Regeneron, SEP 4, 2022, View Source [SID1234618969]). Presentations will include first-in-class efficacy and safety data from Phase 1/2 trials of two investigational bispecific antibodies – ubamatamab (REGN4018; MUC16xCD3) in advanced ovarian cancer and REGN5093 (METxMET) in advanced MET-altered non-small cell lung cancer (NSCLC) – along with presentations of investigational Libtayo (cemiplimab) regimens in four advanced solid tumors, including a combination with investigational fianlimab (LAG-3 inhibitor).
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"Our ESMO (Free ESMO Whitepaper) presentations showcase the broad promise of Regeneron’s oncology pipeline of checkpoint inhibitors and bispecifics – many of which are also being studied in combinations for potentially synergistic treatments," said David Weinreich, M.D., Executive Vice President, Global Clinical Development at Regeneron. "To date, we’ve advanced 14 oncology medicines into the clinic, shown preliminary therapeutic benefits in solid tumors and clinically meaningful results for hematological malignancies with several investigational bispecific antibodies, and received global regulatory approvals for our PD-1 inhibitor Libtayo in multiple cancers. The achievements and progress we’ve made with our oncology pipeline provide a strong foundation as we propel our potentially transformative oncology research forward."
Regeneron currently has three classes of investigational bispecifics in ongoing Phase 1/2 trials. Data for two of these classes will be presented at ESMO (Free ESMO Whitepaper), including a mini-oral on the CD3-targeting bispecific ubamatamab (designed to bridge MUC16 on cancer cells with CD3-expressing T cells to facilitate local tumor-specific T-cell activation) and a poster presentation on the tumor-targeting bispecific REGN5093 (designed to target two different parts of the MET receptor on cancer cells to degrade the receptor and block its ability to trigger cell proliferation). Preliminary clinical data on a third class of investigational bispecific, REGN5678, a CD28-targeted costimulatory bispecific, in advanced castration-resistant prostate cancer were shared in August.
New and updated investigational data for Libtayo as monotherapy and as a potential backbone of several combination treatments will also be presented at ESMO (Free ESMO Whitepaper). In skin cancers, this includes a mini-oral sharing updated expansion cohort results for Libtayo in combination with Regeneron’s LAG-3 inhibitor fianlimab in advanced melanoma and an oral presentation on the primary analysis of a Phase 2 trial of Libtayo monotherapy in neoadjuvant cutaneous squamous cell carcinoma (CSCC). Other notable presentations include a late-breaking analysis from a Phase 3 trial investigating Libtayo in combination with chemotherapy in NSCLC, as well as a mini-oral on final, Phase 3 overall survival results of Libtayo monotherapy in advanced cervical cancer.
Investor Webcast Information
Regeneron will host a conference call and simultaneous webcast to share updates on the company’s oncology portfolio on Monday, September 12 at 14:00 CEST/8:00 AM ET. A link to the webcast may be accessed from the ‘Investors and Media’ page of Regeneron’s website at View Source To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay of the conference call and webcast will be archived on the company’s website for at least 30 days.
Regeneron presentations at ESMO (Free ESMO Whitepaper):
Medicine
Abstract title
Abstract
Presentation
date/time
(all CEST)
Skin cancer
Libtayo
Neoadjuvant cemiplimab in patients with
stage II–IV CSCC: Primary analysis of a
Phase 2 study
#789O
Monday,
September 12
11:05 – 11:15
Libtayo
Phase 2 study of cemiplimab in patients
with advanced CSCC: Final analysis from
EMPOWER-CSCC-1 Groups 1, 2 and 3
#814P
Saturday,
September 10
09:00 – 17:00
Libtayo
Phase 2 confirmatory study of cemiplimab
in patients with locally advanced or
metastatic CSCC: Study 1540 Group 6
#818P
Saturday,
September 10
09:00 – 17:00
Libtayo
CemiplimAb-rwlc Survivorship and
Epidemiology (CASE): A prospective|
study of the safety and efficacy of
cemiplimab in patients with advanced
CSCC in a real-world setting
#825P
Saturday,
September 10
09:00 – 17:00
Fianlimab, Libtayo
Phase 1 study of fianlimab, a human
lymphocyte activation gene-3 (LAG-3)
monoclonal antibody, in combination with
cemiplimab in advanced melanoma
#790MO
Monday,
September 12
08:35 – 08:40
Vidutolimod
Vidutolimod + pembrolizumab as 2L+
treatment in patients with anti-PD-1
refractory melanoma and adrenal
insufficiency: subgroup analyses of a
tudy
#845P
Saturday,
September 10
09:00 – 17:00
Ovarian cancer
Ubamatamab
Ubamatamab (REGN4018, MUC16xCD3
bispecific antibody) monotherapy in
patients with recurrent ovarian cancer:
Phase 1 dose-escalation analysis
#523MO
Saturday,
September 10
09:25 – 09:30
Lung cancer
Libtayo
Cemiplimab with platinum-based
chemotherapy for first-line locally
advanced NSCLC: EMPOWER-Lung 3
subgroup analysis
#954P
Saturday,
September 10
09:00 – 17:00
Libtayo
Clinical interchangeability of PD-L1
immunohistochemistry assays
for the treatment of first-line NSCLC with
cemiplimab
#114P
Saturday,
September 10
09:00 – 17:00
Libtayo
Continued cemiplimab with addition of
chemotherapy in patients with progressive
disease after first-line cemiplimab
monotherapy for advanced NSCLC:
analysis from EMPOWER-Lung 1
LBA54
Sunday,
September 11
15:37-15:47
Libtayo
Patient-reported outcomes of cemiplimab
vs chemotherapy in advanced NSCLC:
EMPOWER-Lung 1 histology subgroups
#1183P
Monday,
September 12
09:00 – 17:00
Libtayo
Factors associated with not receiving first-
line immune checkpoint inhibitor
treatment among patients with advanced
NSCLC and high PD-L1 expression: an
evaluation by age
#1149P
Monday,
September 12
09:00 – 17:00
Libtayo
Outcomes of real-world patients with
advanced NSCLC and high PD-L1
expression receiving first line immune
checkpoint inhibitor therapy
#1105P
Monday,
September 12
09:00 – 17:00
REGN5093
Early safety, tolerability, and efficacy of
REGN5093 in patients with MET-altered
advanced NSCLC from a first in human
study
#1173P
Monday,
September 12
09:00 – 17:00
Cervical cancer
Libtayo
Phase 3 EMPOWER-Cervical 1/GOG-3
016/ENGOT-cx9 trial of cemiplimab in
recurrent or metastatic cervical cancer:
Long-term survival analysis
#519MO
Saturday,
September 10
08:30 – 08:35
Blood cancer
N/A
Real-world health-related quality of life in
patients with Follicular Lymphoma:
Comparisons by line of therapy and
region (Europe vs US)
#634P
Sunday,
September 11
09:00 – 17:00
The potential uses of Libtayo, REGN5678, REGN5093, fianlimab, ubamatamab and vidutolimod described above are investigational, and their safety and efficacy have not been fully evaluated by any regulatory authority.
About Regeneron in Oncology
At Regeneron, we’re applying more than three decades of scientific innovation with the goal of developing paradigm-changing therapies for patients with cancer. Our oncology portfolio is built around two foundational approaches – our approved PD-1 inhibitor Libtayo and investigational bispecific antibodies – which are being evaluated both as monotherapies and in combination with emerging therapeutic modalities. Together, they provide us with unique combinatorial flexibility to develop potentially synergistic treatments for a wide range of solid tumors and blood cancers.
If you are interested in learning more about our clinical trials, please contact us ([email protected] or 844-734-6643) or visit our clinical trials website.
About Libtayo
Libtayo, which was invented using Regeneron’s proprietary VelocImmune technology, 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. In the U.S. and other countries Libtayo is indicated in certain patients with advanced basal cell carcinoma (BCC), advanced cutaneous squamous cell carcinoma (CSCC) and advanced non-small cell lung cancer (NSCLC), as well as in advanced cervical cancer in Canada and Brazil.
In the U.S., the generic name for Libtayo in its approved indications 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 (FDA). Outside of the U.S., the generic name of Libtayo in its approved indication is cemiplimab.
The extensive clinical program for Libtayo is focused on difficult-to-treat cancers. Libtayo is currently being investigated in trials as a monotherapy, as well as in combination with either conventional or novel therapeutic approaches for other solid tumors and blood cancers. These potential uses are investigational, and their safety and efficacy have not been evaluated by any regulatory authority.
U.S. FDA-approved Indications
Libtayo is a prescription medicine used to treat people with:
– A type of skin cancer called advanced CSCC that has spread or cannot be cured by surgery or radiation.
– A type of skin cancer called BCC:
That cannot be removed by surgery (locally advanced BCC) and have received treatment with a hedgehog pathway inhibitor (HHI), or cannot receive treatment with an HHI.
That has spread (metastatic BCC) and have received treatment with an HHI, or cannot receive treatment with an HHI. This use is approved based on how many patients responded to treatment and how long they responded. Studies are ongoing to provide additional information about clinical benefit.
– A type of lung cancer called NSCLC. Libtayo may be used as your first treatment when your lung cancer has not spread outside your chest (locally advanced lung cancer) and you cannot have surgery or chemotherapy with radiation, or your lung cancer has spread to other areas of your body (metastatic lung cancer), and your tumor tests positive for high "PD-L1" and your tumor does not have an abnormal "EGFR", "ALK "or "ROS1" gene.
It is not known if Libtayo is safe and effective in children.
About Regeneron’s VelocImmune Technology
Regeneron’s VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron’s co-Founder, President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create approximately one in five of all original, FDA-approved or authorized fully human monoclonal antibodies. This includes REGEN-COV (casirivimab and imdevimab), Dupixent (dupilumab), Libtayo (cemiplimab-rwlc), Praluent (alirocumab), Kevzara (sarilumab), Evkeeza (evinacumab-dgnb) and Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn).
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 certain cancers 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 of these problems 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 new or worsening signs or symptoms, including:
Lung problems: cough, shortness of breath, or chest pain
Intestinal problems: diarrhea (loose stools) or more frequent bowel movements than usual, stools that are black, tarry, sticky or have blood or mucus, or severe stomach area (abdomen) pain or tenderness
Liver problems: yellowing of your skin or the whites of your eyes, severe nausea or vomiting, pain on the right side of your stomach area (abdomen), dark urine (tea colored), or bleeding or bruising more easily than normal
Hormone gland problems: headache that will not go away or unusual headaches, eye sensitivity to light, eye problems, rapid heartbeat, increased sweating, extreme tiredness, weight gain or weight loss, feeling more hungry or thirsty than usual, urinating more often than usual, hair loss, feeling cold, constipation, your voice gets deeper, dizziness or fainting, or changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness
Kidney problems: decrease in your amount of urine, blood in your urine, swelling of your ankles, or loss of appetite
Skin problems: rash, itching, skin blistering or peeling, painful sores or ulcers in mouth or nose, throat, or genital area, fever or flu-like symptoms, or swollen lymph nodes
Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with Libtayo. Call or see your healthcare provider right away for any new or worsening signs or symptoms, which may include: chest pain, irregular heartbeat, shortness of breath or swelling of ankles, confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs, double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight, persistent or severe muscle pain or weakness, muscle cramps, low red blood cells, or bruising
Infusion reactions that can sometimes be severe. Signs and symptoms of infusion reactions may include: nausea, chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, feel like passing out, fever, back or neck pain, or facial swelling
Rejection of a transplanted organ. Your healthcare provider should tell you what signs and symptoms you should report and monitor you, depending on the type of organ transplant that you have had
Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with Libtayo. Your healthcare provider will monitor you for these complications
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 also need to delay or completely stop treatment with Libtayo 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 received an organ transplant
– have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
– have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome 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 muscle or bone pain, 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.