Is the phase 2 data regarding neoadjuvant cemiplimab in cutaneous squamous cell carcinoma sufficient to adopt for all patients or will you await phase 3 data?

The current data are quite compelling, but not sufficient to adopt for all patients. We need to see the long-term recurrence and survival rates from the phase II study and also perform a confirmatory phase III trial with a survival endpoint. Unless this treatment approach results in equivalent to im...

The phase 2 data are quite impressive with a pathologic complete response (pCR) of 51%. In the pilot study of 20 patients that preceded the phase 2 study, the pCR rate was 55%, but more importantly, all patients who achieved a pCR did not receive adjuvant radiation, and none of the patients who achi...

The TROG trial of surgery + RT (+/- carboplatin) resulted in a 2-year FFLRR of 88% and DFS of 78% with the standard arm. A pretty high bar to overcome. Not clear that neoadjuvant cemiplimab can improve on these numbers. In my opinion, a phase 3 trial would need to be performed on this backbone to sh...

A phase 3 study is in development with a major US cooperative group. The risks of this approach need to be quantified against the potential benefit. The only way to do that in a scientifically sound manner is a randomized trial. Placebo is not part of the design.

I am not aware that an additional study is planned. When a drug results in a 50% complete pathological response rate, I do not think it is ethical to compare it to a placebo when facing a potentially lethal disease.

However, a comparison between neoadjuvant cetuximab-based therapy versus neoadjuvant...

Maybe an important factor is to acknowledge that the cost of Libtayo is $10,128.

I'd wait on phase 3 trial data before accepting a $10k cost increase in the local control of a cutaneous SCCa.