Transcript
My name is Danny Rischin. I'm the Director of Medical Oncology at the Peter McCallum Cancer Center in Melbourne, Australia. I'm discussing today the poster on the adjuvant study of cemiplimab in high-risk CSCC.
CSCCs are common, and a great majority of patients are treated with surgery alone, or surgery and post-operative radiotherapy in the more advanced cases.
We have previous work, including a past study has demonstrated that there is a high-risk group that have a significant failure rate despite standard treatment. In this study, we're looking at these with adjuvant cemiplimab to see if this improves the outcome.
The cemiplimab has been shown in advanced patients, so, patients with metastatic disease or locally advanced disease not suitable for surgery or radiotherapy, to be a very effective treatment.
It's being approved in simplification in many jurisdictions, with a response rate in the 45% to 50% range of durable responses, hence the interest in determining if we move this drug into an earlier stage of disease patients with potentially curable but locally advanced disease, whether we can improve outcomes.
This phase 3 trial is addressing this question in a double-blind, placebo-controlled study of 412 patients over 100 sites across the world. The patients receive standard surgery and post-operative radiotherapy, and then they're randomized between cemiplimab and placebo. They receive cemiplimab or placebo for 12 months.
This study is currently accruing. The primary end point is disease-free survival.
In summary, this phase 3 trial will determine whether the benefits in advanced disease translate to improvement in outcome of patients with locally advanced disease, as adjuvant treatment after surgery and radiotherapy for high-risk locally advanced CSCC.
