Regeneron Unveils Key Oncology Pipeline Updates at ESMO 2025, Highlighting Patient-Centric Approaches for Hard-to-Treat Cancers
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that new and updated data from its oncology pipeline will be presented in seven abstracts at the European Society for Medical Oncology (ESMO) 2025 Meeting, scheduled for October 17–21 in Berlin, Germany. Among the highlights is Phase 3 C-POST data evaluating a novel every-6-week dosing regimen of Libtayo® (cemiplimab) as adjuvant therapy for cutaneous squamous cell carcinoma (CSCC) in adults at high risk of recurrence.
Dr. Israel Lowy, Clinical Development Unit Head for Oncology at Regeneron, emphasized the significance of these presentations. “Our oncology presentations at ESMO represent important progress toward expanding options for people with difficult-to-treat cancers,” he said. “We are particularly excited to share new data from our C-POST Phase 3 trial, demonstrating a patient-centric every-6-week dosing option for Libtayo. This trial recently supported FDA approval of Libtayo as the first immunotherapy indicated for adjuvant treatment in adult patients with CSCC at high risk of recurrence following surgery and radiation.”
Patient-Centric Approach in C-POST Phase 3 Trial
The C-POST trial highlights Regeneron’s focus on patient convenience and safety while maintaining efficacy. Patients in the trial initially received 350 mg of Libtayo every three weeks for 12 weeks. After this period, the majority transitioned to every-six-week dosing, while a smaller subset continued the three-week regimen. Treatment continued until disease recurrence, unacceptable toxicity, or up to 48 weeks.
Key findings from the trial include:
- Comparable efficacy, pharmacokinetics, and immunogenicity between the every-3-week and every-6-week dosing schedules.
- Consistent safety profile of Libtayo as adjuvant therapy in high-risk CSCC patients, in line with known safety data from advanced cancer trials.
- Evidence that less frequent dosing can maintain treatment outcomes while offering greater convenience for patients, reducing hospital visits and treatment burden.
These data underscore Regeneron’s commitment to patient-focused oncology development, prioritizing treatment regimens that integrate seamlessly into patients’ daily lives without compromising therapeutic effectiveness.
Overview of Regeneron’s ESMO 2025 Oncology Presentations
At ESMO 2025, Regeneron will share seven abstracts covering multiple therapeutic areas and investigational treatments:
| Abstract Title | Abstract | Presenter | Session Date/Time (CET) |
|---|---|---|---|
| Analysis of second primary CSCC tumors (SPTs) during the C-POST trial | Mini-oral presentation: 1603MO | Danny Rischin | Saturday, October 18, 14:45–16:15 |
| Adjuvant cemiplimab for high-risk CSCC: Evaluating dosing intervals in Phase 3 trial | Poster presentation: 1660P | Danny Rischin | Monday, October 20, 12:00–12:45 |
| CemiplimAb-rwlc Survivorship and Epidemiology (CASE): Prospective study of cemiplimab in immunocompromised patients with advanced CSCC at 18-month follow-up | Poster presentation: 1666P | Soo J. Park | Monday, October 20, 12:00–12:45 |
| Association between patient-reported outcomes (PROs) and overall survival (OS) in aNSCLC patients treated with first-line cemiplimab-based therapy | Poster presentation: 1862P | David R. Gandara | Saturday, October 18, 12:00–12:45 |
| Randomized Phase 2 study of ubamatamab ± cemiplimab in patients with platinum-resistant ovarian cancer | Poster presentation: 1078P | Jung-Yun Lee | Saturday, October 18, 12:00–12:45 |
| Mitigating infusion-related reactions (IRRs) with cetirizine and montelukast in patients receiving REGN7075, an EGFRxCD28 bispecific antibody | Poster presentation: 1558P | Neil H. Segal | Sunday, October 19, 12:00–12:45 |
| Predicting real-world overall survival in advanced melanoma using machine learning | Poster presentation: 1632P | Fei Wang | Monday, October 20, 12:00–12:45 |
These presentations span multiple cancer types, including cutaneous squamous cell carcinoma (CSCC), advanced non-small cell lung cancer (aNSCLC), platinum-resistant ovarian cancer, and advanced melanoma, highlighting Regeneron’s broad oncology portfolio and pipeline.
Advancing Novel and Investigational Therapies
The presentations also feature investigational agents, such as ubamatamab and REGN7075, which remain under clinical evaluation. While their safety and efficacy have not yet been determined by regulatory authorities, ongoing studies are designed to explore their potential in combination therapies and innovative bispecific antibody approaches.
Through its comprehensive oncology pipeline, Regeneron is striving to address hard-to-treat cancers, emphasizing:
- Patient-focused dosing regimens, reducing visit frequency without compromising efficacy.
- Combination therapies that may enhance responses in resistant or refractory tumors.
- Real-world data analyses leveraging machine learning to improve understanding of treatment outcomes.
Commitment to Patient-Centered Oncology
Regeneron’s focus on patient-centric approaches extends beyond clinical efficacy to include convenience, tolerability, and quality of life. The C-POST trial exemplifies this strategy, offering flexible dosing options that align with patients’ lifestyles while maintaining robust clinical benefits.
“Our goal is to expand treatment options for patients with challenging cancers while ensuring therapies are convenient and manageable,” said Dr. Lowy. “The data we present at ESMO 2025 underscore our commitment to combining scientific rigor with patient-centered innovation.”
