1506 – Programmed cell death ligand 1 (PD-L1) testing to determine PBS access to durvalumab or durvalumab/tremelimumab as 1st line therapy for patients with unresectable Stage IV urothelial cancer

New MBS Item.

PD-L1 is expressed on the surface of tumour cells and immune cells in a broad range of cancer types, including urothelial cancer. PD-L1 aids cancers in evading detection and elimination by the immune system by supressing the anti-tumour T-cell response. The level of PD-L1 expression can be assessed using immunohistochemical (IHC) testing with antibodies that bind specifically to the PD-L1 expressed on the surface of tumour cells or immune cells. IMFINZI™ (durvalumab, MEDI4736) is a human monoclonal antibody that inhibits binding of PD-L1 to programmed cell death receptor 1 (PD-1). Tremelimumab (MEDI1123) is a human monoclonal antibody which specifically binds to cytotoxic T-lymphocyte antigen -4 (CTLA-4), prolonging T cell activation and proliferation and enhancing T-cell anti-tumour activity.

This application is a co-dependent request for MBS listing of PD-L1 testing to determine which Stage IV unresectable urothelial cancer patients have a high level of PD-L1 expression (defined as tumour cells ≥ 25% or immune cells ≥ 25%)* in order to qualify for requested PBS access to 1st line durvalumab monotherapy treatment, and which Stage IV unresectable urothelial cancer patients have a low level of PD-L1 gene expression (defined as tumour cells < 25% or immune cells < 25%)* in order to qualify for requested PBS access to 1st line durvalumab/tremelimumab combination treatment.

Type: Investigative

In Australia in 2013, bladder cancer was the eighth most commonly diagnosed cancer in men (age-standardised rate 16.5 cases per 100,000) but was much less common in women (age-standardised rate 4.1 cases per 100,000).

The 5-year relative survival for bladder cancer patients has slowly declined from 1984-2013. Bladder cancer is rare under the age of 50 and usually presents in old age. Risk factors for bladder cancer include cigarette smoking, carcinogenic chemical exposure, genetic predisposition and prior radiotherapy/chemoradiation in the pelvis/lower abdomen. More than 90% of bladder cancers form in the lining of the urinary tract (the urothelium) and are known as urothelial carcinomas, or transitional cell carcinomas. Urothelial cancers most commonly occur in the bladder, but may also be found in the renal pelvis, ureters and urethra. Bladder cancer is a highly immunogenic tumour type,4 consequently immunotherapy treatments for bladder cancer may alter the disease process. This Application proposes durvalumab or durvalumab/tremelimumab as first line treatment for patients with unresectable Stage IV transitional cell carcinoma (transitional cell and mixed transitional/non-transitional cell histologies) of the urothelium (including renal pelvis, ureters, urinary bladder and urethra).

• PASC meeting: 7 - 8 December 2017
• ESC meeting: -
• MSAC meeting: -