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NICE recommends atezolizumab for metastatic urothelial cancer

5th October 2021

Atezolizumab has been approved by NICE for untreated advanced or metastatic urothelial cancer in adults where PD-L1 levels exceed 5%.

Urothelial carcinoma is the most common form of bladder cancer, accounting for more than 90% of all bladder cancers in the UK. The main symptom is haematuria in around 80% of cases although other symptoms include increased frequency of urination, pain or a burning sensation when passing urine and weight loss. According to Cancer Research UK, between 2016 and 2018, there were approximately 10,300 new cases of bladder cancer in the UK every year.

Atezolizumab is licensed as mono-therapy for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma, either after prior platinum-containing chemotherapy, or in patients who are cisplatin ineligible and whose tumours have a PD-L1 expression ≥ 5%. The checkpoint protein, programmed death-ligand 1 (PD-L1) which is present on the surface of tumour cells, normally binds to programmed death-1 (PD-1) on the surface of T-cells and prevents the T-cells from killing the tumour cells. Atezolizumab is a checkpoint inhibitor that prevents the binding of PD-L1 to PD-1 and thus restores tumour T-cell activity.

Clinical efficacy

Patients with advanced and metastatic urothelial carcinoma have a poor prognosis with 5-year survival rates as low as 6%. The standard treatment is cisplatin-based chemotherapy however, in a 2017 study 119 previously untreated patients who were cisplatin ineligible, were given atezolizumab at a dose of 1200 mg every 3 weeks until progression. The primary outcome was an objective response and which occurred in 23% of patients and a complete response was seen in 9%. The approval by NICE was based on more data, which came from IMvigor130, a multi-centre, Phase III trial, in which 1213 patients were randomised to either atezolizumab plus platinum-based chemotherapy, atezolizumab mono-therapy or placebo plus platinum-based chemotherapy. In its appraisal, NICE only considered a subgroup of 93 people, with untreated PD-L1-positive (tumour expression of 5% or more) locally advanced or metastatic urothelial cancer and who were ineligible to be treated with cisplatin.

The median overall survival was 18.6 months for atezolizumab and 10.0 months for platinum-based chemotherapy. The stratified hazard ratio was 0.50 (95% CI 0.29 to 0.87, p=0.0125), indicating that treatment with atezolizumab was associated with a significant improvement in overall survival compared with platinum-based chemotherapy. Moreover, the median progression-free survival for atezolizumab was 6.4 months compared with 6.0 months for platinum-based chemotherapy.

In its final appraisal document, NICE stated that “atezolizumab meets NICE’s criteria to be considered a life-extending treatment at the end of life. The cost-effectiveness estimates are likely to be within what NICE considers an acceptable use of NHS resources. So atezolizumab is recommended.

Source. NICE 2021