PHASE 3 TRIAL OF LIBTAYO? (CEMIPLIMAB) MONOTHERAPY IN ADVANCED CERVICAL CANCER STOPPED EARLY FOR POSITIVE RESULT ON OVERALL SURVIVAL
Regeneron Pharmaceuticals, Inc.?(NASDAQ:?REGN) and Sanofi today announced positive results demonstrating an overall survival (OS) benefit from the Phase 3 trial investigating the PD-1 inhibitor Libtayo??(cemiplimab) monotherapy compared to chemotherapy, in patients previously treated with chemotherapy whose cervical cancer is recurrent or metastatic. The trial will be stopped early based on a unanimous recommendation by the Independent Data Monitoring Committee (IDMC), and the data will form the basis of regulatory submissions in 2021.
"Libtayo monotherapy is the first medicine to demonstrate an improvement in overall survival in women with recurrent or metastatic cervical cancer following progression on platinum-based chemotherapy in a Phase 3 trial," said Krishnansu S. Tewari, M.D., Professor and Director of the?Division of Gynecologic Oncology?at the?University of California, Irvine?and a trial investigator. "This landmark clinical achievement will bring hope to women with advanced cervical cancer who are often younger than patients with other cancers. This is reflected in this trial where the average age was 51."
This is the largest Phase 3 randomized clinical trial in advanced cervical cancer, and included women (median age: 51 years) with either squamous cell carcinoma or adenocarcinoma. Patients were randomized to receive Libtayo monotherapy (350 mg every 3 weeks) or an investigator's choice of commonly used chemotherapy (pemetrexed, vinorelbine, topotecan, irinotecan or gemcitabine). Compared to chemotherapy, patients receiving Libtayo experienced:
- Total population:?31% reduced risk of death
- Median 12.0 months survival for Libtayo (n=304) compared to 8.5 months for chemotherapy (n=304); hazard ratio (HR): 0.69; 95% confidence interval (CI): 0.56-0.84 (p<0.001)
- Squamous cell carcinoma:?27% reduced risk of death
- Median 11.1 months survival for Libtayo (n=239) compared to 8.8 months for chemotherapy (n=238); HR: 0.73; 95% CI: 0.58-0.91 (p=0.003)
- Adenocarcinoma:?44% reduced risk of death
- Median 13.3 months survival for Libtayo (n=65) compared to 7.0 months for chemotherapy (n=66); HR: 0.56; 95% CI: 0.36-0.85 (p<0.005; not adjusted for multiplicity)
- 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.
- 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-Barr? 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.
Regeneron Contacts: | Sanofi Contacts: |
Media Relations Taylor Ramsey Tel: +1 914-409-2381 taylor.ramsey@regeneron.com Investor Relations Vesna Tosic Tel: +1 914-847-5443 vesna.tosic@regeneron.com | Media Relations
Sally Bain
Tel: +1 781-264-1091
sally.bain
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