Regeneron Presents Positive Data at ASH for REGN1979 CD20xCD3 Bispecific Antibody in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
100% overall and 80% complete response rate in 10 patients with relapsed or refractory follicular lymphoma treated with 5 mg or more of REGN1979
Plan to initiate in 2019 a potentially registrational Phase 2 trial in relapsed or refractory follicular lymphoma
Promising clinical activity also seen in ongoing study in diffuse large B-cell lymphoma
In the data presented at the 2018
REGN1979 also showed encouraging dose-dependent clinical activity in heavily pre-treated patients with R/R DLBCL. Among patients receiving doses between 5 mg and 12 mg, the ORR was 18% (2 of 11 patients, including 1 CR and 1 PR). At doses of 18 mg to 40 mg, the ORR increased to 60% (6 of 10 patients, including 2 CR and 4 PR). Regeneron plans to continue dose-escalation in DLBCL.
"While a high response rate is frequently observed in the first-line treatment of follicular lymphoma, it is remarkable to see a 100% response rate in heavily pre-treated relapsed or refractory follicular lymphoma patients," said
"There have been tremendous recent advances in the field of immuno-oncology, with new breakthrough therapies including checkpoint inhibitors and personalized cell-based therapies," said
The objectives for this ongoing Phase 1 proof-of-concept trial are to assess safety, tolerability and efficacy of REGN1979 monotherapy. The data presented at ASH included a total of 68 patients with R/R B-
In the trial, the most common TEAEs occurring in at least 25% of patients were pyrexia, chills, cytokine release syndrome (CRS), fatigue, increased C-reactive protein, anemia, hypotension, infusion-related reaction (IRR) and nausea. IRR and CRS events were generally mild to moderate in severity, and neither resulted in trial discontinuations. Three patients in the trial died due to adverse events. Of these, one death, in a patient with a tumor involving the gastric lining who experienced a gastric perforation, was attributed to REGN1979.
REGN1979 was invented by Regeneron using the company's proprietary VelocImmune® technology that yields optimized fully-human antibodies, and Regeneron's proprietary Veloci-Bi™ bispecific platform. Veloci-Bi allows for the generation of full-length bispecific antibodies similar to native antibodies that are amenable to production by standard antibody manufacturing techniques, and likely to have favorable antibody-like pharmaco-kinetic properties.
REGN1979 was granted orphan drug designation by the
Libtayo is being developed jointly by Regeneron and
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
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.
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
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.
For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.
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