First immunotherapy listed on PBS for advanced cutaneous SCC

About 1000 patients with cutaneous squamous cell carcinoma (CSCC) will gain subsidised access to the checkpoint inhibitor cemiplimab (Libtayo) following its listing on the PBS from 1 November.

The immunotherapy has been listed on the PBS for the treatment of metastatic or locally advanced cutaneous squamous cell carcinoma, in patients who are not candidates for curative surgery or curative radiation.

The drug, which was approved by the TGA for use in Australia in 2020 is the first immunotherapy to be subsidised for the advanced type of non-melanoma skin cancer that has a median survival of less than 15 months, according to Professor Danny Rischin, a medical oncologist at Peter MacCallum Cancer Centre, Melbourne.

“Advanced CSCC can cause a great deal of distress due to severe pain, marked alteration of facial appearance, and impact on critical facial structures and function e.g., eyes, ears and nose,” he said in a statement released by sponsor Sanofi-Aventis.

“[Cemiplimab] is the first reimbursed treatment option available specifically for patients for whom curative surgery and radiation is not an option or not suitable. [It] provides an alternative to surgery that could cause severe disfigurement or dysfunction, or impact on critical functions e.g., removal of an eye.”

As previously reported in the limbic, cemiplimab was approved based on trials that included Australian patients with advanced CSCC, and in which objective response was observed in 44% of patients.

When considering submission for PBS listing the Pharmaceutical Benefits Advisory Committee ( PBAC) noted that CSCC accounts for about 20-30% of nonmelanoma skin cancers and Australia has the highest rates of CSSC in the world.

In less than 5% of patients with CSCC, the condition can progress to an advanced stage, either by not being eligible for curative surgery or radiation treatment (laCSCC) or by having metastatic disease (mCSCC).

The committee said there was a high unmet need for effective treatment for advanced stage CSCC which “is associated with reduced overall survival and with large and wide spread lesions that can interfere with essential functions and may have a disfiguring effect, which cumulatively reduces the patients’ quality of life.

Cemiplimab is a recombinant human monoclonal antibody that targets the programmed death 1 (PD-1) receptor, which potentiates T-cell responses, including anti-tumour responses.

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