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 phase 2 study of cemiplimab in patients with advanced CSCC, with longer follow-up.
CSCC is usually cured with surgery alone in majority of cases. There is a proportion of patients with advanced disease that cannot be treated with surgery or radiotherapy.
In this population, cemiplimab, which is an anti-PD-1 drug, has shown significant activity and has been registered and approved in many jurisdictions for advanced CSCC.
In this study, we're presenting the updated data pooling the results of the first 3 groups, and really the key messages are the durability of responses and the increase in complete response rate over time.
In this study, with the 3 groups, groups 1 and 3 are patients with metastatic disease, and group 2 are patients with locally advanced disease that were not amenable to the surgery and radiotherapy.
The groups 1 and 2 received weight-based dosing every 2 weeks for up to 2 years, and in group 3, a flat dose of 350 milligrams intravenously every 3 weeks, which could be extended for up to 2 years.
This was an elderly population. The median age was 72, and the oldest patient treated was 96. Across the 3 groups, there were 193 patients, with median follow-up of about 16 months, and follow-up extending to 3 years.
When we look at the results, the primary end point was response rate, and the response rate for the pooled population is 46 percent.
When you look at the complete response rate for group one, for which we have the longest follow-up, we can see that it's increased over time, with only 7% of the first analysis, 17% of the second analysis, and 20% now at the third analysis, so, increasing responses over time, even after the drug itself has been ceased.
The other impressive result is the durability of these responses. We're able to show that of the patients that respond, 88% have an ongoing response at 12 months, and 70% at 24 months. The median progression-free survival was 18.4 months. In terms of overall survival, at 2 years, 73% of patients are still alive.
These are really quite remarkable results compared to previously, where there were limited treatment options for these patients, and the median overall survival was only 15 months.
In summary, these updated results demonstrate that cemiplimab has a high response rate. Its responses are durable, and the complete responses improve over time.
