Non-Melanoma Skin Cancers Coverage from Every Angle

AACR 2021: Is Pembrolizumab Effective in Treating Advanced Cutaneous Squamous Cell Carcinoma?

By: Vanessa A. Carter, BS
Posted: Friday, April 16, 2021

Brett G.M. Hughes, MD, of Royal Brisbane and Women’s Hospital and the University of Queensland, Herston, Australia, and colleagues conducted a study investigating pembrolizumab's use for patients with locally advanced or recurrent/metastatic cutaneous squamous cell carcinoma. This trial's results, which support the use of this immunotherapy in this patient population, were presented at the American Association for Cancer Research (AACR) Annual Meeting 2021 (Abstract CT006).

“Pembrolizumab confirmed robust and durable antitumor activity, with promising survival in locally advanced and recurrent/metastatic cutaneous squamous cell carcinoma,” the researchers concluded. “Adverse events with pembrolizumab in this study were generally consistent with its established safety profile.”

The phase II, KEYNOTE-629 study enrolled 159 patients with histologically confirmed cutaneous squamous cell carcinoma who had an Eastern Cooperative Oncology Group performance status of 0 or 1 and sufficient organ function. Pembrolizumab was administered intravenously at 200 mg for 3 weeks until 35 infusions or discontinuation criteria were met.

The median time to data cutoff was 14.9 months for the locally advanced (n = 54) cohort and 27.2 months for the recurrent/metastatic (n = 105) group. Prior systemic therapy was recorded in 22.2% of this with locally advanced disease and 86.7% of those with recurrent or metastatic disease. The locally advanced and recurrent/metastatic groups' objective response rates were 50.0% and 35.2%, respectively; the disease control rates were 64.8% and 52.4%.

When compared with the locally advanced group, the recurrent/metastatic group fared better in achieving complete response (9 vs. 11), partial response (18 vs. 26), and stable disease (21 vs. 48). The 12-month progression-free survival rate was 54.4% for the locally advanced group and 36.4% for the recurrent/metastatic cohort; the 12-month overall survival rates were 73.6% and 61.0%, respectfully. Grade 3 to 5 treatment-related adverse events affected 11.9% of individuals across cohorts, and similar grade immune-related adverse events occurred in 8.2%.

Disclosure: For full disclosures of the study authors, visit

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