The Overview
Regeneron Pharmaceuticals announced the presentation of new clinical research at the European Society for Medical Oncology (ESMO) Congress 2026, taking place from October 23-27 in Madrid, Spain. The company will present 10 abstracts covering various cancers, including cutaneous squamous cell carcinoma (CSCC), non-small cell lung cancer (NSCLC), ovarian cancer, melanoma, and cancer-associated thrombosis. Key presentations include late-breaking Phase 3 C-POST data providing longer-term overall survival outcomes for adjuvant Libtayo (cemiplimab) in high-risk CSCC after surgery and radiation, and a final Phase 2 analysis exploring neoadjuvant Libtayo for resectable CSCC. Additionally, data on Factor XI antibodies (cenvacibart and amrecibart) will be shared, investigating their potential to reduce thrombosis in cancer patients. This reflects Regeneron's commitment to advancing comprehensive cancer care.
Knolens Analysis
At a Glance
| Indication | Cutaneous Squamous Cell Carcinoma |
| Drug | Cemiplimab |
| Mechanism of Action | PD-1 inhibitor |
| Company | Regeneron Pharmaceuticals, Inc. |
| Trial Phase | Phase 3 |
| Trial Acronym | C-POST |
| Category | Clinical Trial Event |
| Sub Category | Conference Presentation |
| Therapeutic Area | Oncology |
| Conference Name | European Society for Medical Oncology (ESMO) Congress 2026 |
| Conference Dates | October 23-27, 2026 |
| Conference Location | Madrid, Spain |
| Follow-up Duration | approximately 3.5 years |
| Number of Abstracts | 10 |
| Other Indications Covered | Non-small cell lung cancer (NSCLC), Ovarian cancer, Melanoma, Cancer-associated thrombosis |
| Other Drugs Mentioned | Ubamatamab, Cenvacibart, Amrecibart, Fianlimab |
| Other Trial Acronyms | ROXI-CAT-II, ROXI-CATH, EMPOWER-Lung 3 Part 2, CEMI-LUNG |
| Regulatory Authority | U.S. FDA |
Regeneron Presents New Oncology Data at ESMO 2026
Regeneron Pharmaceuticals announced the presentation of new clinical research at the European Society for Medical Oncology (ESMO) Congress 2026, taking place from October 23-27 in Madrid, Spain. The company will present 10 abstracts covering various cancers, including cutaneous squamous cell carcinoma (CSCC), non-small cell lung cancer (NSCLC), ovarian cancer, melanoma, and cancer-associated thrombosis. Key presentations include late-breaking Phase 3 C-POST data providing longer-term overall survival outcomes for adjuvant Libtayo (cemiplimab) in high-risk CSCC after surgery and radiation, and a final Phase 2 analysis exploring neoadjuvant Libtayo for resectable CSCC. Additionally, data on Factor XI antibodies (cenvacibart and amrecibart) will be shared, investigating their potential to reduce thrombosis in cancer patients. This reflects Regeneron's commitment to advancing comprehensive cancer care.
- Adjuvant Libtayo in High-Risk CSCC: Late-breaking overall survival (OS) data from the Phase 3 C-POST trial will be presented, showing outcomes at approximately 3.5 years follow-up. These data are expected to further support Libtayo (cemiplimab) as a standard of care for adults with high-risk CSCC after surgery and radiation, demonstrating its long-term efficacy in preventing recurrence and improving patient outcomes in this challenging indication.
- Neoadjuvant Libtayo in Resectable CSCC: The final analysis of Phase 2 results for neoadjuvant Libtayo (cemiplimab) in Stage II-IV CSCC will be shared. This represents the most mature dataset available for patients treated with Libtayo prior to surgery, exploring its potential to improve outcomes in resectable CSCC by reducing tumor burden before definitive surgical intervention. This approach aims to enhance resectability and potentially improve long-term prognosis for patients.
- Factor XI Antibodies for Cancer-Associated Thrombosis: New data will be presented on Factor XI antibodies, cenvacibart and amrecibart, as a potential strategy to reduce thrombosis in cancer patients. This includes a Phase 2 sub-analysis and modeling for catheter-related VTE, along with an update on the ongoing Phase 3 ROXI-CAT-II trial. This research addresses a critical complication in cancer care where bleeding risk often limits the use of conventional anticoagulants, offering a novel therapeutic avenue.
Frequently Asked Questions
What is the success rate of cemiplimab?
Cemiplimab's efficacy, often considered its "success rate," is indication-specific and measured by various clinical endpoints. In advanced cutaneous squamous cell carcinoma, objective response rates (ORR) range from 44-47%, while for advanced basal cell carcinoma, ORR is approximately 29-31%. For first-line non-small cell lung cancer with PD-L1 ≥50%, cemiplimab monotherapy demonstrates an ORR of about 36% and significantly improves overall survival compared to chemotherapy. In recurrent or metastatic cervical cancer, it has shown an ORR of 16.4% and improved overall survival versus chemotherapy.
What is the best immunotherapy for treating squamous cell carcinoma?
Optimal immunotherapy for squamous cell carcinoma varies by primary site, stage, and patient factors. However, PD-1 inhibitors such as pembrolizumab, nivolumab, and cemiplimab are the cornerstone of immunotherapy for various advanced squamous cell carcinomas, including cutaneous, head and neck, and lung subtypes. These agents are approved and widely utilized, often as first-line or subsequent therapy, demonstrating significant clinical benefit.
How long can you be on cemiplimab?
Cemiplimab treatment is generally continued until disease progression or unacceptable toxicity. This applies across its approved indications, including advanced cutaneous squamous cell carcinoma, basal cell carcinoma, non-small cell lung cancer, and cervical cancer. The specific duration for an individual patient is determined by clinical response, tolerability, and the treating physician's assessment.
What is the survival rate for cutaneous squamous cell carcinoma?
The overall 5-year survival rate for localized cutaneous squamous cell carcinoma (cSCC) is exceptionally high, often exceeding 95-98% with appropriate treatment. However, survival rates decline significantly for advanced disease. For cSCC with regional lymph node metastasis, the 5-year survival rate typically ranges from 30-70%, further decreasing to 10-30% for distant metastatic disease. These rates are influenced by factors such as tumor stage, location, perineural invasion, and patient immune status.
What are the newest treatments for squamous cell skin cancer?
The newest treatments for advanced squamous cell skin cancer primarily involve immune checkpoint inhibitors. Cemiplimab (Libtayo) was the first FDA-approved PD-1 inhibitor for metastatic or locally advanced CSCC not amenable to curative surgery or radiation. More recently, pembrolizumab (Keytruda) also received approval for recurrent or metastatic CSCC not curable by surgery or radiation. These therapies represent significant advancements in systemic treatment options for this patient population.
Can I wait 3 months for squamous cell carcinoma to be removed?
Delaying squamous cell carcinoma (SCC) removal for three months is generally not advisable. While many SCCs are low-risk, some can be locally invasive, grow rapidly, and have metastatic potential, especially high-risk lesions. A significant delay could lead to increased tumor size, deeper invasion, more complex treatment, and a higher risk of adverse outcomes. Prompt surgical excision is typically recommended to minimize these risks and ensure optimal patient prognosis.
What is the new procedure instead of Mohs surgery?
While Mohs micrographic surgery remains the gold standard for high-risk non-melanoma skin cancers, advanced radiation therapy techniques are emerging as a non-surgical alternative. Procedures like stereotactic radiotherapy (SRT) and image-guided radiotherapy (IGRT) offer highly precise tumor targeting and sparing of healthy tissue. These methods are increasingly utilized for patients who are not surgical candidates or for tumors in anatomically challenging locations.
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