Dr Patel on the Treatment Gap in High-Risk CSCC

Vishal A. Patel, MD, FAAD, FACMS, associate professor of Dermatology and of Medicine (Hematology/Oncology) at George Washington (GW) University School of Medicine and Health Sciences and director, Cutaneous Oncology Program at GW Cancer Center, speaks to Targeted Oncology about the treatment gap in high-risk cutaneous squamous cell carcinoma (CSCC)—a gap now fulfilled by the pivotal phase 3 C-POST trial (NCT03969004) and the FDA’s recent approval of adjuvant cemiplimab (Libtayo) for this indication on October 8, 2025.

Watch the first part of Dr Patel’s interview.

Historically, there has been a significant therapeutic gap in CSCC due in part to the lack of evidence in a randomized setting demonstrating clinically meaningful benefits, specifically reducing the risk of recurrence in this patient population. According to Patel, the “simple and stark” unmet need is prevention of recurrence, as recurrences often come with not only disfiguring, unresectable growths, but also substantial mortality risk and decreased quality of life. While some have suggested that salvage therapy with immunotherapy is a superior approach, utilizing an adjuvant approach to prevent recurrence may help improve quality of life while simultaneously delivering in efficacy.

The decision to proceed with adjuvant therapy, however, requires careful consideration and a discussion between the patient and provider regarding the individual patient's context. Patel emphasizes the importance of considering nuances such as age, existing comorbidities, and life expectancy, as adjuvant therapy may be more or less impactful depending on these factors. For instance, adjuvant therapy may be more feasible and meaningful for younger patients who may be more amenable to the systemic toxicities associated with adjuvant therapy.

The availability of robust data from the C-POST trial and subsequent FDA approval offer an important option for patients, filling this long-unfilled gap.

Read the full interview here.