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Avelumab approved by SMC as maintenance therapy for urothelial cancer

Avelumab has been approved as first-line maintenance immunotherapy for patients with locally advanced or metastatic urothelial cancer.

Urothelial carcinoma (UC) is the most common form of bladder cancer, accounting for around 90% of all cases. There are a number of symptoms of bladder cancer including increased frequency of urination, urgency, pain or a burning sensation. However, many of these symptoms have other possible causes although the most common symptom is the non-painful passage of blood in the urine and occurs in 80% of patients. Furthermore, 5-year survival among those with advanced urothelial cancer is low and estimated to be less than 5%. While the use of platinum-based chemotherapy, i.e., cisplatin, carboplatin and oxaliplatin, is effective, 5-year survival rates are low at 13 to 15%. Moreover, bladder cancer has a high rate of recurrence, with one UK-based analysis finding that nearly three-quarters (74%) of patients had urothelial cancer after 10 years. After successful platinum-based chemotherapy, there has been a suggestion that maintenance treatment will help prolong remission. One such maintenance therapy is avelumab, a checkpoint inhibitor which targets the protein, PD-L1 and in doing so, activates the immune system to destroy cancerous cells. However, in England and Wales, NICE has recommended against the use of avelumab as a maintenance treatment for urothelial cancer, after platinum-based chemotherapy. In contrast, the Scottish Medicines Consortium (SMC) has recommended avelumab mono-therapy as a first-line maintenance treatment of locally advanced or metastatic urothelial carcinoma.

Clinical data
Approval by the SMC was based on results from the Phase III JAVELIN Bladder. This was a multi-centre trial that enrolled 700 patients, at 197 sites in 29 different countries, with unresectable locally advanced or metastatic urothelial cancer and who had previously received first-line chemotherapy. Patients were randomised to best supportive care with or without avelumab and the primary endpoint was overall survival. The overall 1-year survival was 71.3% in the avelumab group compared to 58.4% in the control arm, with a median survival of 21.4 months verses 14.3 months (avelumab vs control), and the hazard ratio for death was 0.69 (95% CI 0.56 – 0.86, p = 0.001). In other words, there was a 31% reduction in the risk of death in patients receiving avelumab. Adverse effects occurred in more patients treated with avelumab (98% vs 77.7%) and these led to treatment discontinuation in 11.9% of avelumab patients.

Commenting on the approval, chief executive of Fight Bladder Cancer, Lydia Makaroff, said “We are delighted to see that this maintenance treatment has been approved by the SMC. This treatment may give bladder cancer patients good quality time and is the biggest change in advanced bladder cancer management we have had in decades.”

The Merck-Pfizer Alliance has submitted an appeal to NICE to ensure that all eligible patients with urothelial cancer have equitable access to this treatment.

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