Cemiplimab in Metastatic Basal Cell Carcinoma: Durable Outcomes With Real-World Relevance for Payers
A study recently published in Future Oncology highlights the emerging role of cemiplimab, an immune checkpoint inhibitor, in the management of metastatic basal cell carcinoma (mBCC). Although basal cell carcinoma (BCC) is the most common skin cancer globally, metastatic disease remains exceedingly rare and carries limited treatment options. Historically, systemic therapy has relied on hedgehog pathway inhibitors (HHIs), including vismodegib and sonidegib, which target aberrant signaling that drives tumor growth. However, the long-term tolerability and modest efficacy of HHIs have left significant gaps in care for patients whose disease progresses or who cannot tolerate these agents.
The study examined cemiplimab—a programmed death-1 (PD-1) inhibitor that harnesses the immune system to recognize and destroy cancer cells—as a novel therapeutic approach for mBCC. Cemiplimab was approved by the US Food and Drug Administration (FDA) for patients with locally advanced or metastatic BCC who previously received, or were ineligible for, HHI therapy. The article synthesized findings from clinical trials and real-world studies, outlining cemiplimab’s pharmacologic profile, safety, and clinical efficacy across diverse patient populations.
In pivotal clinical trials, cemiplimab demonstrated an objective response rate of approximately 22% among patients with mBCC who had progressed on or could not tolerate HHIs. Importantly, many responses were durable, with some patients maintaining disease control for extended periods. Compared to HHIs, cemiplimab was associated with a more favorable tolerability profile, with fatigue, diarrhea, and cutaneous reactions being the most common treatment-related adverse events. The review also emphasized cemiplimab’s potential to preserve health-related quality of life, as treatment discontinuations due to toxicity were infrequent.
Real-world evidence supports these trial results, suggesting that cemiplimab offers meaningful clinical benefit in broader, more heterogeneous patient populations. While response rates in mBCC are somewhat lower than those observed in cutaneous squamous cell carcinoma, the findings suggest a durable immunotherapeutic effect that extends beyond traditional cytotoxic approaches. Ongoing investigations are exploring cemiplimab in neoadjuvant settings and combination regimens, as well as efforts to identify predictive biomarkers to optimize patient selection and improve outcomes.
The growing body of evidence surrounding cemiplimab underscores the increasing integration of immunotherapy into the management of rare and advanced skin cancers. For managed care professionals, these developments highlight key considerations in coverage, formulary inclusion, and long-term value assessment. As immunotherapies like cemiplimab demonstrate durable responses and improved tolerability, their potential to reduce downstream healthcare utilization and enhance patient quality of life will be essential in shaping future strategies for cost-effective, evidence-based oncology care.
Reference
Bapna M, Ruiz E. Cemiplimab in the treatment of metastatic basal cell carcinoma. Future Oncol. 2025;21(16):1999-2005. doi:10.1080/14796694.2025.2511568
