‘Life-changing’ treatment wins PBS approval

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Patients with advanced cutaneous squamous cell carcinoma to benefit from subsidised immunotherapy.

The first immunotherapy approved in Australia for use in advanced cutaneous squamous cell carcinoma will be available on the PBS from 1 November.

The listing of cemiplimab (Libtayo, Sanofi) is expected to annually benefit about 1000 Australians with advanced CSCC where curative surgery and curative radiation are not suitable. Up until now there has been no specific subsidised treatments available.

The PBS-listing will apply to adults with metastatic or locally advanced cutaneous squamous cell carcinoma (mCSCC or laCSCC), when curative surgery and curative radiation is not suitable. Without subsidy, patients might pay more than $144,000 per course of treatment with cemiplimab.

The move has been embraced by clinicians, including specialists who have been involved in clinical trials and using the treatment.

Sydney dermatologist Associate Professor Saxon Smith told The Medical Republic the decision was a “game changer” for these patients, particularly those whose disease involved the head or neck.

He said he had been involved with clinical trials of cemiplimab and was impressed by its efficacy.

“The results have shown it’s improving outcomes for a substantial number or patients, especially patients with advances cutaneous squamous cell carcinoma in the head and neck,” Professor Smith said.

“There’s so much morbidity and mortality where the head and neck are involved and where there is lymph involvement. There can be massive surgery, months of treatment and months of recovery and rehabilitation.

“Having this on the PBS is a massive step forward. It’s definitely a game-changer.”

Professor Danny Rischin, a medical oncologist at the Peter MacCallum Cancer Centre, has been treating patients with cemiplimab for the past six years.

“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.

He said this was the first reimbursed treatment option that provided an alternative to surgery that could cause severe disfigurement or dysfunction, or impact on critical functions, such as the removal of an eye.

Professor Rischin said he had patients who had been treated with cemiplimab who were still enjoying good quality of life five years later. These patients would have otherwise not survived, he said.

He said another advantage of the drug was that it could work very quickly and was generally well-tolerated.

“It does transform people’s lives,” he said.

An immune checkpoint inhibitor, cemiplimab is a fully human immunoglobulin G4 (IgG4) monoclonal antibody. It works by binding to the programmed cell death-1 (PD-1) receptor to inhibit cancer cells from using the PD-1 pathway to suppress T-cell activation. This enables the body’s immune system to remain active so it can attack and kill cancer cells.

It is contraindicated in patients with a hypersensitivity to cemiplimab or any of its excipients. Special warnings and precautions for use include immune-related adverse reactions (pneumonitis, colitis, hepatitis, endocrinopathies, skin adverse reactions, nephritis) and infusion-related reactions.

Provisional approval for cemiplimab in advanced CSCC was first granted by the TGA in 2020 on the basis of objective response rate (ORR) and duration of response from single arm clinical studies.

Kasia Siwek, head of medical specialty care at Sanofi Australia and New Zealand, said the company welcomed the PBS listing.

“Australian cancer specialists have played a leading role in a global CSCC clinical trial for Libtayo, and we are delighted that a broader group of clinicians will now be able to offer Libtayo to suitable patients,” she said.

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