Regeneron’s Libtayo Trial Shows Promise for High-Risk CSCC
Key Trial Findings
Regeneron Pharmaceuticals revealed significant results from its Phase 3 C-POST trial of Libtayo (cemiplimab), a PD-1 inhibitor. This treatment showed a 68% reduction in disease recurrence or death in high-risk cutaneous squamous cell carcinoma (CSCC) patients after surgery. Libtayo outperformed placebo in disease-free survival and recurrence rates. Results were presented at the 2025 American Society of Clinical Oncology Annual Meeting and published in the New England Journal of Medicine. Regulatory applications for Libtayo’s use in adjuvant CSCC treatment have been submitted in the U.S. and EU.
Positive Highlights
- Libtayo’s 68% reduction in disease recurrence or death indicates its strong efficacy.
- Presentation at a major oncology conference raises the credibility of the findings.
- Regulatory applications could expand market opportunities for Libtayo.
Challenges Faced
- Adverse events occurred in both treatment and placebo groups, with 91% and 89% experiencing any grade of adverse events, respectively.
- 10% of Libtayo patients discontinued treatment due to adverse events, compared to 2% in the placebo group.
- Two deaths during treatment raised safety concerns for Libtayo.
Frequently Asked Questions
What were the main findings of the Libtayo trial?
Libtayo demonstrated a 68% reduction in disease recurrence or death among high-risk CSCC patients.
How does Libtayo compare to placebo?
Libtayo achieved significant reductions in locoregional and distant recurrences of 80% and 65%, respectively, compared to placebo.
Where were the trial results presented?
The results were shared at the 2025 American Society of Clinical Oncology Annual Meeting and published in NEJM.
What is the current regulatory status of Libtayo?
Regulatory applications for Libtayo have been submitted in the U.S. and EU for adjuvant CSCC treatment.
How does PD-L1 expression affect Libtayo’s effectiveness?
Libtayo reduced disease recurrence risk by 72% in tumors with PD-L1 ≥1% and by 68% in PD-L1 1% tumors.
Disclaimer: This is an AI-generated summary based on a press release from GlobeNewswire, which may contain inaccuracies. For full details, refer directly to the original source.
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Summary of Libtayo Performance
Libtayo showed a 68% reduction in disease recurrence or death and significant reductions in locoregional and distant recurrence rates of 80% and 65%, respectively. Presentations were made at the 2025 American Society of Clinical Oncology Annual Meeting, with regulatory submissions pending in the U.S. and EU.
# Libtayo Shows Promise in Phase 3 Trial for High-Risk Skin Cancer
## Overview of the C-POST Trial Findings
Regeneron announced the results of the Phase 3 C-POST trial evaluating PD-1 inhibitor Libtayo (cemiplimab) in patients with high-risk cutaneous squamous cell carcinoma (CSCC) post-surgery. The findings were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and published in the *New England Journal of Medicine*.
### Importance of Systemic Therapies
Lead investigator Dr. Danny Rischin highlighted the lack of effective systemic therapies to prevent relapse in high-risk CSCC. He emphasized that the C-POST trial demonstrated cemiplimab’s efficacy, showcasing clinically significant outcomes and low recurrence rates.
## Efficacy Results
Earlier results established Libtayo as the first immunotherapy to show a significant benefit in the adjuvant setting for high-risk CSCC. At ASCO, additional data confirmed positive effects on disease-free survival (DFS), defined as the time from randomization to recurrence or death.
With a median follow-up of 24 months, Libtayo outperformed placebo:
– **DFS** improved significantly: 68% reduction in recurrence or death (hazard ratio [HR]: 0.32; 95% confidence interval [CI]: 0.20-0.51; p<0.0001), with median DFS not reached for Libtayo (49 months for placebo).
- DFS at two years: 87% for Libtayo vs. 64% for placebo.
- **Locoregional recurrence** risk reduced by 80% (HR: 0.20; 95% CI: 0.09-0.40).
- **Distant recurrence** risk reduced by 65% (HR: 0.35; 95% CI: 0.17-0.72).
Updated overall survival (OS) data indicated a potential benefit (HR: 0.78; 95% CI: 0.39-1.56).
## Safety Profile
Safety assessments involved 205 patients receiving Libtayo and 204 on placebo. Adverse events (AEs) occurred in 91% of the Libtayo group and 89% of the placebo group. Serious AEs (Grade ≥3) were noted in 24% of Libtayo patients versus 14% in placebo. Common AEs in Libtayo patients included fatigue, rash, and hypothyroidism. Treatment discontinuation due to AEs was 10% for Libtayo compared to 2% for placebo.
## Regulatory Status
Regeneron has submitted applications for Libtayo's use in treating adjuvant CSCC in the U.S. and European Union.
## About the Phase 3 Trial
The C-POST trial was a randomized, placebo-controlled study involving 415 patients with high-risk CSCC features after surgery and post-operative radiation. Subjects received Libtayo for up to 48 weeks, with dosing adjustments over time.
## About Libtayo
Libtayo is a human monoclonal antibody targeting the PD-1 receptor on T cells. It was developed using Regeneron's VelocImmune technology, aiming to block cancer cells from inhibiting T-cell activation.# Libtayo Secures Approval in Over 30 Countries for Cancer Treatment
Libtayo, a cancer treatment, has received approval from regulatory bodies in more than 30 countries for various indications. These include adult patients with advanced basal cell carcinoma (BCC), advanced cutaneous squamous cell carcinoma (CSCC), advanced non-small cell lung cancer (NSCLC), and advanced cervical cancer.
In the U.S., Libtayo is known as cemiplimab-rwlc, following the Nonproprietary Naming of Biological Products Guidance from the U.S. FDA. Outside the U.S., it is simply called cemiplimab.
The drug is part of an extensive clinical program targeting challenging cancers. Currently, Libtayo is being investigated in trials both as a standalone treatment and in combination with other therapies for various solid and blood cancers. These potential applications are still under investigation, and their safety and effectiveness have yet to be confirmed by regulatory agencies.
Approved Indications in the U.S.
Libtayo is indicated for:
- Patients with cutaneous squamous cell carcinoma (CSCC) that cannot be cured by surgery or radiation.
- Patients with basal cell carcinoma (BCC) that cannot be surgically removed or has metastasized, particularly if they have previously been treated with a hedgehog pathway inhibitor (HHI) or are unable to do so.
- Adults with non-small cell lung cancer (NSCLC), with specific conditions for treatment combinations and other criteria.
Libtayo’s safety and efficacy in children is not established.
Important Safety Information for U.S. Patients
Libtayo may enhance immune responses to treat certain cancers but can also cause serious side effects by affecting normal organs and tissues. These side effects may occur anytime during or after treatment.
Immediate Medical Attention Required
Consult your healthcare provider if you experience:
- Lung issues: Symptoms include cough, shortness of breath, or chest pain.
- Intestinal problems: Look for diarrhea, black stools, or severe abdominal pain.
- Liver problems: Signs include skin yellowing, nausea, or dark urine.
- Hormone gland disturbances: Symptoms may be headache, weight changes, or mood alterations.
- Kidney issues: Decreased urination or blood in urine is a concern.
- Skin reactions: Watch for rashes, sores, or flu-like symptoms.
- Infusion reactions: Severe responses may include nausea, chills, or difficulty breathing.
Severe complications like graft-versus-host disease can also occur in patients who have received a bone marrow transplant.
Prompt medical treatment is essential to mitigate these risks. Healthcare providers will monitor for side effects and may adjust treatment if needed. Before starting Libtayo, inform your provider about all medical conditions and medications.
# Regeneron Updates on LIBTAYO Use and Side Effects
## Common Side Effects of LIBTAYO
LIBTAYO (cemiplimab) presents several side effects. When used alone, common effects include tiredness, muscle or bone pain, rash, diarrhea, and anemia. When combined with platinum-containing chemotherapy, patients may experience hair loss, muscle or bone pain, nausea, fatigue, numbness, and decreased appetite. For medical advice on side effects, consult your doctor. Side effects can also be reported to the FDA at 1-800-FDA-1088 or Regeneron at 1-877-542-8296.
## Overview of Regeneron’s VelocImmune Technology
Regeneron’s VelocImmune technology leverages a genetically engineered mouse platform, allowing for the development of fully human antibodies. Pioneered by co-founder George D. Yancopoulos in 1985, this innovative method has produced numerous FDA-approved monoclonal antibodies, including Dupixent, Libtayo, and Praluent. The technology was vital in developing REGEN-COV, authorized for use during the COVID-19 pandemic until 2024.
## Company Background
Regeneron (NASDAQ: REGN) specializes in developing life-changing medicines for serious illnesses. Founded by physician-scientists, the firm effectively translates scientific research into approved treatments. Current offerings target a broad range of diseases, including cancer, eye conditions, and rare diseases. Their proprietary technology, including VelociSuite®, enhances drug development.
For more information, visit [www.Regeneron.com](http://www.Regeneron.com).
## Forward-Looking Statements
This press release includes forward-looking statements that carry inherent risks and uncertainties regarding Regeneron’s future performance. Terms like “anticipate,” “expect,” and “believe” indicate these statements. Risks involve timelines and potential success related to Regeneron’s products and candidates, regulatory approvals, market acceptance, and supply chain management. The impact of safety concerns and reimbursement factors for their therapies may also affect outcomes.# Regeneron Faces Multiple Risks Amid Development and Market Challenges
## Introduction to Regeneron’s Risks
Regeneron Pharmaceuticals is navigating a complex landscape shaped by various factors. These include changes in healthcare laws, competing products, and uncertainties surrounding clinical trials and financial projections.
## Significant Factors Impacting Regeneron
Health payors are implementing new policies that may affect Regeneron’s operations. Additionally, changes in regulations are influencing the broader healthcare sector. The emergence of competing drugs, including biosimilars, could pose challenges to Regeneron’s product offerings.
## Research and Development Concerns
The success of Regeneron’s research programs remains uncertain. The replication of successful results in other studies is not guaranteed, which can delay the progression of product candidates into clinical trials or regulatory approval.
## Financial Projections
Regeneron faces challenges in meeting its financial projections. This includes unanticipated expenses and the costs associated with developing and marketing its products.
## Legal and Regulatory Risks
The company is also dealing with potential risks related to license agreements, such as those with Sanofi and Bayer. Public health threats, like epidemics or pandemics, may further complicate business operations.
## Ongoing Legal Proceedings
Regeneron is currently involved in civil proceedings instigated by the U.S. Department of Justice. These legal challenges, along with issues relating to intellectual property and patent litigation concerning EYLEA® (aflibercept) Injection, have the potential to impact its business and financial performance.
### Important Disclosures
A detailed overview of these risks is available in Regeneron’s filings with the U.S. Securities and Exchange Commission, including the Form 10-K for the year ending December 31, 2024, and the Form 10-Q for the quarterly period ending March 31, 2025. Forward-looking statements are based on current management beliefs, and reliance on these statements is cautioned.
## Investor Relations Information
Regeneron communicates important updates via its media and investor relations website, as well as social media platforms. Financial information about the company can be accessed at Regeneron’s investor relations website and LinkedIn page.
This article was originally published on Quiver News.
