Libtayo® (cemiplimab) Recommended for EU Approval by the CHMP for Adjuvant Treatment of Cutaneous Squamous Cell Carcinoma (CSCC) with a High Risk of Recurrence After Surgery and Radiation
Regeneron (NASDAQ: REGN) announced that the EMA CHMP issued a positive opinion for Libtayo (cemiplimab) as adjuvant treatment for adult cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation on Oct 17, 2025.
The decision is supported by Phase 3 C-POST results: risk of recurrence or death −68% (HR 0.32; 95% CI 0.20–0.51; p<0.0001). Locoregional recurrence was 4% vs 17% and distant recurrence 5% vs 13% (Libtayo vs placebo). Detailed data published in NEJM May 2025. European Commission final decision expected in the coming months.
Safety: AEs 91% vs 89%; Grade ≥3 AEs 24% vs 14%; discontinuation 10% vs 2%; two deaths per arm.
Regeneron (NASDAQ: REGN) ha annunciato che l'EMA CHMP ha emesso un'opinione positiva per Libtayo (cemiplimab) come trattamento adiuvante per l'adulto con carcinoma a cellule squamose cutaneo (CSCC) ad alto rischio di recidiva dopo chirurgia e radioterapia, il 17 ottobre 2025.
La decisione è supportata dai risultati di fase 3 C-POST: rischio di recidiva o morte −68% (HR 0,32; IC al 95% 0,20–0,51; p<0,0001). La recidiva loco-regionale è stata del 4% contro 17% e la recidiva a distanza 5% contro 13% (Libtayo vs placebo). Dati dettagliati pubblicati su NEJM maggio 2025. La decisione finale della Commissione europea è prevista nei prossimi mesi.
Sicurezza: Eventi avversi (EA) 91% vs 89%; eventi avversi di grado ≥3 24% vs 14%; interruzione 10% vs 2%; due decessi per braccio.
Regeneron (NASDAQ: REGN) anunció que la CHMP de la EMA emitió una opinión positiva para Libtayo (cemiplimab) como tratamiento adyuvante para adultos con carcinoma de células escamosas cutáneas (CSCC) de alto riesgo de recidiva tras cirugía y radioterapia, el 17 de octubre de 2025.
La decisión está respaldada por los resultados de la fase 3 C-POST: riesgo de recidiva o muerte −68% (HR 0,32; IC del 95% 0,20–0,51; p<0,0001). La recidiva locorregional fue del 4% frente a 17% y la recidiva a distancia del 5% frente a 13% (Libtayo vs placebo). Datos detallados publicados en NEJM mayo de 2025. Se espera la decisión final de la Comisión Europea en los próximos meses.
Seguridad: EA 91% vs 89%; EA de grado ≥3 24% vs 14%; interrupción 10% vs 2%; dos muertes por brazo.
Regeneron (NASDAQ: REGN)은 EMA CHMP가 성인 피부 편평세포암(CSCC)에서 수술 및 방사선 치료 후 재발 위험이 높은 환자에 대한 보조 치료제로 Libtayo (cemiplimab)에 대해 긍정적 의견을 발표했다는 소식을 2025년 10월 17일에 발표했다.
이 결정은 제3상 C-POST 결과로 뒷받침된다: 재발 또는 사망 위험 −68% (HR 0.32; 95% CI 0.20–0.51; p<0.0001). 국소-광역 재발은 4% 대 17%, 원격 재발은 5% 대 13%(Libtayo 대 위약). 자세한 데이터는 NEJM 2025년 5월에 게재됐다. 유럽 집행위원회의 최종 결정은 향후 몇 개월 내에 기대된다.
안전성: AEs 91% 대 89%; 등급 ≥3 AEs 24% 대 14%; 중단 10% 대 2%; 각 팔당 두 명의 사망.
Regeneron (NASDAQ: REGN) a annoncé que le CHMP de l'EMA a rendu une opinion positive pour Libtayo (cemiplimab) en tant que traitement adjuvant pour les adultes atteints de carcinome cutané épidermoïde (CSCC) à haut risque de récidive après chirurgie et radiothérapie, le 17 octobre 2025.
La décision est soutenue par les résultats de la phase 3 C-POST: risque de récidive ou de décès −68% (HR 0,32; CI à 95% 0,20–0,51; p<0,0001). La récidive locorégionale était de 4% contre 17% et la récidive à distance de 5% contre 13% (Libtayo versus placebo). Données détaillées publiées dans NEJM mai 2025. La décision finale de la Commission européenne est attendue dans les mois à venir.
Sûreté: EA 91% contre 89%; EA de grade ≥3 24% contre 14%; interruption 10% contre 2%; deux décès par bras.
Regeneron (NASDAQ: REGN) kündigte an, dass der EMA-CHMP eine positive Stellungnahme zu Libtayo (cemiplimab) als adjuvante Behandlung für Erwachsene mit kutanem Plattenepithelkarzinom (CSCC) mit hohem Rezidivrisiko nach Operation und Strahlentherapie am 17. Oktober 2025 abgegeben hat.
Die Entscheidung wird von den Phase-3-Ergebnissen C-POST gestützt: Risikoreduktion für Rezidiv oder Tod −68% (HR 0,32; 95%-KI 0,20–0,51; p<0,0001). Lokoregionäre Rezidive 4% vs 17% und distale Rezidive 5% vs 13% (Libtayo vs Placebo). Detaillierte Daten veröffentlicht in NEJM Mai 2025. Die abschließende Entscheidung der Europäischen Kommission wird in den kommenden Monaten erwartet.
Sicherheit: Nebenwirkungen (AEs) 91% vs 89%; AEs Grad ≥3 24% vs 14%; Abbruch 10% vs 2%; zwei Todesfälle pro Arm.
Regeneron (NASDAQ: REGN) أعلنت أن EMA CHMP أصدرت رأيًا إيجابيًا بخصوص Libtayo (cemiplimab) كعلاج مساعد للبالغين المصابين بسرطان الخلايا الحرشفية الجلدية (CSCC) عالي الخطورة من الانتكاس بعد الجراحة والعلاج الإشعاعي في 17 أكتوبر 2025.
يستند القرار إلى نتائج المرحلة 3 C-POST: خطر الانتكاس أو الوفاة −68% (HR 0.32؛ CI 95% 0.20–0.51؛ p<0.0001). الانتكاس المحلي-الإقليمي كان 4% مقابل 17% والانتكاس البعيد 5% مقابل 13% (Libtayo مقابل البلاسيبو). البيانات التفصيلية منشورة في NEJM مايو 2025. من المتوقع أن تتخذ المفوضية الأوروبية القرار النهائي خلال الأشهر المقبلة.
السلامة: AEs 91% مقابل 89%; AEs من الدرجة ≥3 24% مقابل 14%; الانسحاب 10% مقابل 2%; وفاةان بكل ذراع.
Regeneron (NASDAQ: REGN)宣布，欧洲药品管理局药品委员会（EMA CHMP）就 Libtayo (cemiplimab) 作为术后高风险成人皮肤鳞状细胞癌（CSCC）辅助手段给予积极意见，适用于手术和放疗后的高风险复发患者，时间为 2025年 10月 17日。
该决定得到 III 期 C-POST 结果的支持：复发或死亡风险降低 −68%（HR 0.32；95% 置信区间 0.20–0.51；p<0.0001）。局部区域复发率为 4% 对 17%，远处转移为 5% 对 13%（Libtayo 对照安慰剂）。详细数据发表在 NEJM 2025年5月。欧洲委员会最终决定预计在未来几个月内公布。
安全性：不良事件（EA） 91% 对 89%；≥3 级不良事件 24% 对 14%；中断治疗 10% 对 2%；每臂两例死亡。
- CHMP issued a positive opinion for adjuvant CSCC (Oct 17, 2025)
- Risk of recurrence or death −68% (HR 0.32; 95% CI 0.20–0.51)
- Locoregional recurrence 4% vs 17% (Libtayo vs placebo)
- Distant recurrence 5% vs 13% (Libtayo vs placebo)
- Results published in NEJM May 2025
- Grade ≥3 adverse events higher: 24% vs 14%
- Treatment discontinuations higher: 10% vs 2%
- Hypertension was the only grade ≥3 AE >2% in Libtayo arm
Insights
Adjuvant Libtayo showed a large, statistically robust reduction in recurrence or death in high‑risk CSCC.
The Phase 3 C-POST result shows a hazard ratio of 0.32 with a 95% CI of 0.20-0.51 and p<0.0001, indicating a 68% lower risk of disease recurrence or death versus placebo.
The benefit appears across locoregional and distant recurrence rates (4% vs. 17% and 5% vs. 13%, respectively). Safety findings are consistent with known monotherapy data: AEs occurred in 91% versus 89%, grade ≥3 AEs in 24% versus 14%, and treatment discontinuation in 10% versus 2% for Libtayo and placebo.
Watch the
CHMP positive opinion materially advances European regulatory pathway for adjuvant Libtayo.
The CHMP positive opinion follows a clear primary endpoint success in C-POST and an FDA approval earlier this month, creating sequential regulatory momentum toward European authorization.
Key dependencies include the European Commission's final decision in the coming months and the tolerability trade-offs shown by higher grade ≥3 AEs and discontinuations with Libtayo. Monitor the Commission decision timeline and any labeling or post‑marketing commitments tied to the NEJM data.
Positive opinion based on results of Phase 3 C-POST trial that show Libtayo significantly reduced the risk of disease recurrence or death by
TARRYTOWN, N.Y., Oct. 17, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Libtayo® (cemiplimab) as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation. The European Commission is expected to make a final decision on the application in the coming months. Libtayo was approved by the U.S. Food and Drug Administration (FDA) for these patients in the U.S. earlier this month.
The positive opinion is supported by results from the global Phase 3 C-POST trial investigating adjuvant Libtayo versus placebo in patients with CSCC at high risk of recurrence following surgery and radiation. In the trial, Libtayo reduced the risk of disease recurrence or death by
The safety profile of Libtayo as adjuvant treatment of patients with CSCC at high risk of recurrence after surgery and radiation is consistent with the known safety profile for Libtayo monotherapy in advanced cancers. In the trial, adverse events (AEs) occurred in
About the Phase 3 Trial
C-POST was a randomized, placebo-controlled, double-blind, multicenter, global Phase 3 trial investigating Libtayo versus placebo as adjuvant treatment for patients with features associated with a high risk of CSCC recurrence and who had completed surgery and post-operative radiation therapy. Trial participants were at high risk of recurrence due to nodal features (extracapsular extension or ≥3 involved lymph nodes) and/or non-nodal features (in-transit metastases, T4 lesion, perineural invasion, or locally recurrent tumor with ≥1 additional poor prognostic features).
The trial enrolled 415 patients who were randomized to receive either Libtayo (n=209) or placebo (n=206) for up to 48 weeks. For the first 12 weeks, Libtayo 350 mg or placebo was administered intravenously every three weeks, followed by Libtayo 700 mg or placebo administered intravenously every six weeks for 36 weeks.
About CSCC
Cutaneous squamous cell carcinoma (CSCC) is a type of non-melanoma skin cancer (NMSC), and one of the most common cancers in the world. In the EU, the incidence of NMSC overall is expected to increase by
About Regeneron in Cancer
We aspire to turn revolutionary discoveries into medicines that can transform the lives of those impacted by cancer. Our team around the world is driven to solve the needs and challenges of those affected by one of the most serious diseases of our time.
Backed by our legacy of scientific innovation and a deep understanding of biology, genetics and the immune system, we’re pursuing potential therapies across more than 30 types of solid tumors and blood cancers. Our cancer strategy is powered by cutting-edge technologies and therapies that can be flexibly combined to investigate potentially transformative treatments for patients. Oncology assets in clinical development comprise nearly half of Regeneron’s pipeline, and include checkpoint inhibitors, bispecific antibodies and costimulatory bispecific antibodies. Our approved PD-1 inhibitor Libtayo serves as the backbone of many of our investigational combinations.
To complement our extensive in-house capabilities, we collaborate with patients, healthcare providers, governments, biopharma companies and each other to further our shared goals. Together, we are united in the mission to serve as a beacon of transformation in cancer care.
About Libtayo
Libtayo is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T cells and was invented using Regeneron's proprietary VelocImmune® technology. By binding to PD-1, Libtayo has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation. Libtayo has been approved by regulatory authorities in more than 30 countries in one or more indications, including for certain adult patients with advanced basal cell carcinoma (BCC), CSCC that is advanced or at high risk of recurrence, advanced non-small cell lung cancer (NSCLC) and advanced cervical cancer.
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. FDA. Outside of the U.S., the generic name of Libtayo in its approved indications 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:
- Adults with a type of skin cancer called cutaneous squamous cell carcinoma (CSCC):
- that has spread or cannot be cured by surgery or radiation, or
- to help prevent CSCC from coming back if your CSCC is at high risk of coming back after it has been removed by surgery and radiation.
- Adults with a type of skin cancer called basal cell carcinoma (BCC) when your BCC cannot be removed by surgery (locally advanced BCC) or when it has spread (metastatic BCC) and have received treatment with a hedgehog pathway inhibitor (HHI), or cannot receive treatment with a HHI.
- Adults with a type of lung cancer called non-small cell lung cancer (NSCLC).
- LIBTAYO may be used in combination with chemotherapy that contains a platinum medicine 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 does not have an abnormal “EGFR,” “ALK,” or “ROS1” gene.
- LIBTAYO may be used alone 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.
IMPORTANT SAFETY INFORMATION 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 or life-threatening. Signs and symptoms of infusion reactions may include: nausea, vomiting, 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 or tissue. Your healthcare provider should tell you what signs and symptoms you should report and monitor you, depending on the type of organ or tissue 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 complication
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 or tissue transplant, including corneal transplant
- have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
- have received radiation treatment to your chest area
- 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 to 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 when used alone to treat CSCC that has spread or cannot be cured by surgery or radiation, BCC or NSCLC include tiredness, muscle or bone pain, rash, diarrhea, and low levels of red blood cells (anemia).
The most common side effects of LIBTAYO when used alone to help prevent CSCC from coming back include rash and itching.
The most common side effects of LIBTAYO when used in combination with platinum-containing chemotherapy to treat NSCLC include hair loss, muscle or bone pain, nausea, tiredness, numbness, pain, tingling, or burning in your hands or feet, and decreased appetite.
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 at 1-877-542-8296.
Please see full Prescribing Information, including Medication Guide.
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 a substantial proportion of all original, FDA-approved or authorized fully human monoclonal antibodies. This includes Dupixent® (dupilumab), Libtayo, Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab-dgnb), Inmazeb® (atoltivimab, maftivimab and odesivimab-ebgn) and Veopoz® (pozelimab-bbfg). In addition, REGEN-COV® (casirivimab and imdevimab) had been authorized by the FDA during the COVID-19 pandemic until 2024.
About Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases.
Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite®, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases.
For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn, Instagram, Facebook or X.
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These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Products”) and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Product Candidates”) and research and clinical programs now underway or planned, including without limitation Libtayo® (cemiplimab); the impact of the opinion adopted by the European Medicines Agency's Committee for Medicinal Products for Human Use discussed in this press release on the potential approval by the European Commission of Libtayo as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma (“CSCC”) at high risk of recurrence after surgery and radiation; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron’s Product Candidates and new indications for Regeneron’s Products, including Libtayo for the treatment of CSCC in the European Union as discussed in this press release, Libtayo as a monotherapy or in combination with either conventional or novel therapeutic approaches for other solid tumors and blood cancers, and Regeneron’s other oncology assets in clinical development referenced in this press release; 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FAQ
What did Regeneron (REGN) announce about Libtayo on Oct 17, 2025?
How much did Libtayo reduce recurrence or death in the Phase 3 C‑POST trial (REGN)?
What were the recurrence rates with Libtayo versus placebo in C‑POST (REGN)?
What safety differences did the C‑POST trial report for Libtayo (REGN)?
Has Libtayo been published or peer‑reviewed for the adjuvant CSCC data (REGN)?
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