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 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 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 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 neoadjuvan...

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.