Real-World Data and Neoadjuvant Use in cSCC

Dr. Park discusses the importance of real-world data for cSCC, noting that trial populations often exclude the older, frailer, and more medically complex patients seen in everyday practice, including those with poor performance status, organ dysfunction, autoimmune disease, transplant history, or hematologic malignancies. She highlights cemiplimab's phase 4 registry data, which captured outcomes in patient subsets excluded from pivotal trials, including solid organ transplant patients and those with hematologic malignancies. Response rates were broadly consistent with trial data, reinforcing that the drug works across a wider population. She reframes the key clinical question as not whether the drug works, but whether it can work safely in a given patient and whether that patient will live long enough to benefit.

Dr. Singh raises the neoadjuvant setting. Dr. Park cites the phase 2 trial published in NEJM in 2022 (Gross et al.), which showed a 51% pathologic complete response rate with up to four doses of cemiplimab. An additional 13% achieved a major pathologic response (≤10% residual tumor). All patients achieving a pathologic CR were able to avoid adjuvant radiation and remain disease-free. Dr. Park considers neoadjuvant cemiplimab for clinical T3 lesions (AJCC), nodal involvement, and in-transit disease, viewing it as an evolving standard of care for appropriately selected high-risk patients.