Adjuvant immunotherapy for resected Stage III/IV (high risk) melanoma patients has been listed on the PBS.
From 1 March, subsidised access to nivolumab (Opdivo) has been widened to include adjuvant treatment of completely resected stage IIIB, IIIC, IIID and stage IV malignant melanoma, regardless of BRAF mutation.
The move is estimated more than 1,500 patients might otherwise pay more than $100,000 per course of treatment without the PBS subsidy.
The PBS listing of nivolumab and ipilimumab is also being expanded to allow use as a first-line therapy in the treatment of BRAF V600 mutant positive Stage III or Stage IV unresectable or metastatic melanoma.
The listings were welcomed by Associate Professor Matteo Carlino, medical oncologist at Melanoma Institute Australia.
“Adjuvant therapy has changed the landscape of treatment. We now have an adjuvant treatment option that is available for both BRAF-mutant and BRAF wild-type melanoma patients,” he said.
“We have a lot of experience using immunotherapies in the later stages of the disease and we are looking forward to being able to provide a reimbursed option to melanoma patients in an adjuvant setting,” said Associate Professor Carlino.
In a statement, the Melanoma Institute Australia said the listing was supported by clinical trials showing nivolumab’s effectiveness in preventing the disease from progressing to Stage IV and spreading throughout the body.
In the CheckMate 238 study in patients with Stage IIIB/C and Stage IV (AJCC 7th Edition) completely resected melanoma, recurrence-free survival (RFS) was significantly improved with nivolumab, with 58% of patients remaining recurrence-free at 3 years, compared to 45% of those treated with ipilimumab.
“Importantly, today’s PBS listing also includes immunotherapy as first line treatment for high risk and advanced melanoma patients who are BRAF positive. Previously, these patients were required to first undergo treatment with BRAF inhibitors and were only eligible for subsidised immunotherapy after their melanoma progressed or recurred,” the MIA statement said.
Dr Benjamin Brady, a medical oncologist in the Skin and Melanoma Service at Peter Mac said the wider access to immunotherapy would give clinicians and melanoma patients more treatment choices.
“So, in our stage 3 patients- my clinical thing is patients would have a 50% cure by having surgery. It’s now 70% cure with the Opdivo. That’s what I’m saying to my patients.
“[And] when we meet patients in the clinic with advanced melanoma – that might be to the lung or the liver or what have you – we can now make a clinical choice on what the best way forward on the first line setting. So that’s been something we’ve been after for a couple of years and it’s very exciting to have it now available,” he said.