Regeneron announced that the European Commission has approved its PD‑1 inhibitor Libtayo (cemiplimab) for adjuvant therapy in adult patients with high‑risk cutaneous squamous cell carcinoma (CSCC) who have undergone surgery and radiation. The decision, made on November 19, 2025, extends Libtayo’s EU indication from advanced CSCC to the earlier adjuvant setting, making it the first and only immunotherapy approved in the region for this indication.
The approval is grounded in the Phase 3 C‑POST trial, which demonstrated a 68 % reduction in the composite endpoint of disease recurrence or death (hazard ratio 0.32, 95 % CI 0.20‑0.51, p < 0.0001). The study enrolled 1,000 high‑risk CSCC patients and reported a 3‑year disease‑free survival rate of 78 % for Libtayo versus 48 % for placebo, underscoring the drug’s clinical benefit in a population that currently has no approved systemic therapy in the adjuvant setting.
The CSCC market is sizable and growing. Global estimates project the treatment market to rise from roughly USD 13.7 billion in 2024 to USD 27.5 billion by 2034, a CAGR of 7.2 %. Europe alone represents a significant share of this growth, driven by increasing non‑melanoma skin cancer incidence. Libtayo’s existing EU approvals for advanced CSCC, advanced basal cell carcinoma, advanced non‑small‑cell lung cancer, and recurrent or metastatic cervical cancer give Regeneron a broad immunotherapy platform; the new adjuvant indication adds a larger patient cohort and positions Libtayo ahead of competitors such as MSD’s Keytruda, which failed in a similar CSCC adjuvant study.
Regeneron’s oncology strategy emphasizes checkpoint inhibitors as a backbone for combination development. The adjuvant approval expands Libtayo’s addressable market in Europe, potentially adding thousands of new patients and reinforcing the company’s market share in a high‑growth area. The company’s global net sales for Libtayo reached USD 1.22 billion in 2024, a 40 % increase from 2023, and the drug’s performance in the advanced setting suggests strong commercial momentum that can be leveraged in the new indication.
Management highlighted the significance of the approval. George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer, said, “The approval of Libtayo in the adjuvant setting marks a meaningful shift in how high‑risk CSCC is treated and underscores our commitment to expanding immunotherapy options where unmet needs remain.” Paolo Bossi, M.D., noted, “Libtayo’s disease‑free survival benefit in high‑risk patients could change the outlook for those who currently face a persistent risk of recurrence.”
The approval also aligns with Regeneron’s broader pipeline, which includes bispecific antibodies and costimulatory agents. With Libtayo’s proven safety profile—grade 3 or higher adverse events in 24 % of patients versus 14 % for placebo—and a manageable discontinuation rate of 10 % versus 2 % for placebo, the drug’s risk‑benefit profile supports its expanded use. The company’s focus on oncology, combined with the growing CSCC market, positions Regeneron to capture a significant share of the European adjuvant therapy landscape.
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