Patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation can now be treated with immunotherapy for the first time. The PD-1 inhibitor cemiplimab was approved as the first evidence-based system therapy.
Cutaneous squamous cell carcinoma (CSCC) is the second most common form of skin cancer and accounts for the majority of non-melanoma skin cancer deaths in advanced stages – with a mortality rate of over 70% in the metastatic stage. Now the first and so far only evidence-based systemic therapy has been approved . The PD-1 inhibitor cemiplimab (LIBTAYO®) may be used as monotherapy to treat adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiotherapy. The recombinant all-human IgG4 monoclonal antibody binds specifically to the programmed cell death-1 receptor (PD-1), blocking ligand interaction with PD-L1 and PD-L2.
The two-year approval is based on results from the open-label, multicenter, non-randomized Phase II EMPOWER-CSCC-1 study and is supported by two expansion cohorts from a multicenter, open-label, non-randomized Phase I study. It was shown that almost every second patient benefited from the new treatment. 45.5% of patients with locally advanced cutaneous squamous cell carcinoma (laCSCC) achieved objective tumor regression (ORR). In patients with metastatic disease (mCSCC), the ORR was 44.3%. A complete response (CR) was present in 11.4% of laCSCC patients and in 9.2% of mCSCC.
Source: “LIBTAYO® (cemiplimab) is approved in Switzerland for the treatment of advanced cutaneous squamous cell carcinoma (CSCC),” May 27, 2020, sanofi-aventis (Switzerland) ag.
InFo ONCOLOGY & HEMATOLOGY 2020, 8(3): 27.
