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Cemiplimab significantly reduced recurrence in patients with high-risk disease following surgery and radiation, with a two-year disease-free survival (DFS) rate of 87.1% compared to 64.1% in the control group. These patients included those with nodal involvement, T4 tumors, perineural invasion, or locally recurrent disease. However, nearly 10% of patients still discontinued therapy.

The C-POST trial investigated adjuvant cemiplimab vs placebo in high-risk cutaneous squamous cell carcinoma (CSCC) post-surgery and radiation, demonstrating significant improvement in disease-free survival (DFS) (24-month 87% vs 64%) with a 68% reduction in recurrence or death risk (HR 0.32). There were also reduced locoregional and distant recurrence rates. If approved, this would be the first drug in this indication, so keep an eye out for the FDA review.

The Alliance A091802 phase II trial evaluated avelumab + cetuximab vs avelumab alone in advanced-cSCC, demonstrating an improvement in progression-free survival (PFS) (11.1 vs 3.0 months) with a hazard ratio (HR) of 0.48. The combo achieved a modestly higher overall response rate (ORR) (27.6% vs 21.4%), suggesting synergy of the dual blockade. This non-chemotherapy combo shows real promise for our patients with advanced cSCC, but we’ll need to keep an eye on the toxicity profile (more rash and allergic reactions) as we consider it for broader use.

Granted, this is a small study of 12 patients, it is nice to see an official report indicating safety regarding the use of CPI in the setting of advanced cutaneous SCC’s secondary to chronic immunosuppressive therapy after renal transplant. Patients were treated with steroids and rapamycin before/after the cemiplimab infusions, and no patients had rejection events.

Impressive phase II results from MDA, confirming many of our prior anecdotal experiences with this drug. Not a randomized study but it is now approved in the locally advanced and metastatic setting. Responses were seen across all subgroups including PD1-neg patients.