No systemic therapies are currently approved for patients with advanced-stage cutaneous squamous cell carcinoma (SCC), a form of nonmelanoma skin cancer. Now, the findings of a phase I/II trial demonstrate the safety and efficacy of the anti-PD-1 antibody cemiplimab in this patient population.
In the expansion cohort of the phase I study, 26 patients with advanced-stage disease received cemiplimab. Treatment proved to be well tolerated and effective, with a response rate of 50% and durable disease control achieved in 65% of patients.
In the phase II cohort, which included 59 patients with either regional (24%) or distant (76%) metastatic disease, 47% of patients had a response to treatment, with a disease control rate of 61%. Median disease-free survival and overall survival were not reached at the time of data cut-off, at a median follow-up duration of 7.9 months.
Grade ≥3 adverse events, including diarrhoea, fatigue, constipation, anaemia, and pneumonitis, were observed in 42% of patients and resulted in 4 patients discontinuing treatment owing to an adverse event. Notably, 11 patients in the cohort died during the study period, of which 3 deaths were attributed by the investigators to adverse events.
The authors comment that the high response rates observed among unselected patients in this study most likely reflect several distinct biological characteristics of cutaneous SCCs: these include the high tumour mutational burden, which is typically similar to that of microsatellite instability high tumours of other primary histologies, and the increased risk of cutaneous SCCs in individuals with chronic immunosuppression.
In conclusion, these findings provide a new treatment approach for patients with cutaneous SCC that is similarly effective against both locally advanced and metastatic disease. A phase II clinical trial exploring the efficacy of cemiplimab in patients with locally advanced cutaneous SCC is currently underway.
Migden, M. R. et al. PD-1 blockade with cemiplimab in advanced cutaneous squamous-cell carcinoma. N. Engl. J. Med. https://doi.org/10.1056/NEJMoa1805131 (2018)
About this article
Cite this article
Sidaway, P. Cemiplimab effective in cutaneous SCC. Nat Rev Clin Oncol 15, 472 (2018). https://doi.org/10.1038/s41571-018-0056-5
Cetuximab is efficient and safe in patients with advanced cutaneous squamous cell carcinoma: a retrospective, multicentre study
Frontiers in Pharmacology (2020)
Frontiers in Pharmacology (2019)