Melanoma specialist deems new PBS listing ‘particularly significant’

Pharma News: Australians battling unresectable or metastatic melanoma will soon have access to a pioneering immunotherapy treatment, as Bristol-Myers Squibb’s Opdualag (nivolumab/relatlimab) is set to be listed on the Pharmaceutical Benefits Scheme (PBS) starting February 1, 2024.

The listing comes as part of the PBS reimbursements since 1st January, which has already provided Australians access to affordable and innovative therapies for advanced ovarian cancer (Lynparza), chronic lymphocytic leukaemia and small lymphocytic lymphoma (Calquence), cystic fibrosis (Orkambi), and atypical haemolytic uraemic syndrome (aHUS) (Ultomiris).

Opdualag represents Australia’s first combined anti-PD-1/anti-LAG-3 treatment for patients aged 12 years or older dealing with unresectable or metastatic melanoma. This combination therapy, a fixed-dose combination of nivolumab (PD-1 inhibitor) and relatlimab (LAG-3-blocking antibody), holds promise in restoring the effector function of exhausted T-cells and promoting antitumour activity.

The decision to include Opdualag in the PBS was substantiated by the compelling clinical trial data from the Phase 2/3 RELATIVITY-047 study. In patients with treatment-naïve unresectable Stage III or metastatic melanoma, Opdualag more than doubled the median progression-free survival (PFS) compared to nivolumab alone. At a median follow-up of 13.2 months, the combination demonstrated a PFS of 10.1 months, compared to 4.6 months with nivolumab alone (p=0.006).

Co-Medical Director of Melanoma Institute Australia and 2024 NSW Australian of the Year, Professor Georgina Long, AO, expressed the significance of this approval in the realm of melanoma treatment. Despite notable progress in the past decade, Professor Long emphasised the need for more treatment options to enhance patient outcomes.

“This approval is particularly significant, as it shows commitment and focus on bringing innovative drug therapy options to patients, and targeting two different immune checkpoints — LAG-3 and PD-1 – does just that,” said Professor Long

Founder and Director of the Melanoma & Skin Cancer Advocacy Network (MSCAN), Tamara Dawson, welcomed the reimbursement of Opdualag, emphasising the importance of affordable treatment options. While advancements have been made in treating advanced melanoma, the addition of a new combination immunotherapy treatment to the PBS is a welcome development for Australians grappling with the disease.

Dr Melinda Munns, Medical Director for Bristol-Myers Squibb Australia and New Zealand, echoed these sentiments, underlining the commitment to expanding dual immunotherapy treatment options.

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