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Phase II Trial Shows Antitumor Activity With Cemiplimab in mCSCC

Alexander D. Guminski, MD, PhD
Published Online:1:39 PM, Thu July 11, 2019

Alexander D. Guminski, MD, PhD, a medical oncologist at the Royal North Shore Hospital in Australia, discusses the 12-month follow-up data from a phase II study investigating the role of cemiplimab (Libtayo) as a treatment for patients with metastatic cutaneous squamous cell carcinoma (mCSCC).

Fifty-nine patients with mCSCC were enrolled and received cemiplimab every 2 weeks on this trial. The median duration of follow-up for data presented at the 2019 ASCO Annual Meeting was 16.5 months. The primary endpoint was overall survival (OS). After seeing some maturity in the data for this follow-up, Guminski says there was a slight improvement in OS.

The overall response rate (ORR) was 49.2%. Of the 59 patients, 10 had achieved a complete response and 19 achieved a partial response. Median progression-free survival was 18.4 months, but the median OS had not yet been reached.

Guminski says that this is a group of pretreated patients where more than half had received at least 2 prior lines of therapy. Additionally, three-quarters of the patients also had distant visceral disease. This patient population is at a high risk of death from their malignancy, which makes these data very interesting.
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