The National Institute for Health and Care Excellence (NICE) has issued a Final Appraisal Determination (FAD) recommending Bristol Myers Squibb’s nivolumab for the adjuvant treatment of adult patients with muscle invasive urothelial carcinoma (MIUC), who are at high risk of recurrence following radical surgical resection, and whose tumours express PD-L1 at a level of 1% or more.
It is recommended only if adjuvant treatment with platinum-based chemotherapy is unsuitable. Urothelial carcinoma is the most common form of bladder cancer, accounting for more than 90% of cases in the UK, but it can also occur in the renal pelvis or the ureter.
The decision is supported by data from the Phase 3 CheckMate-274 clinical trial, which demonstrated that at a minimum follow up of 11.4 months, over two-thirds of MIUC patients (67.6%) with a PD-L1 expression level of 1% or more who received nivolumab as an adjuvant therapy (N=140), following surgery, were still alive and disease-free 12 months after randomisation, compared to 46.3% who received placebo (N=142)
(hazard ratio, 0.53; 95% CI, 0.38 to 0.75).
At a minimum follow-up of 5.9 months, nivolumab had a generally manageable safety profile in the intention-to-treat population of the study, with treatment-related adverse events (TRAEs) of grade 3 or higher occurring in 17.9% of patients in the nivolumab group (N=353) and 7.2% in the placebo group (N=356).
Furthermore, exploratory analyses showed the quality of life of patients receiving nivolumab was maintained compared to those who received placebo, as measured through the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).
Urothelial cancer occurs in the cells which form the inner lining of the bladder, urethra, ureter, or renal pelvis, but most commonly occurs in the bladder. Approximately 10,300 people are diagnosed with bladder cancer in the UK every year, making it the 11th most common cancer in the UK and the 8th most common cancer in men.
Invasive urothelial carcinoma is when cancerous cells spread beyond the lining into the surrounding bladder muscle and is normally treated by surgery to completely remove the bladder (radical resection). Following surgery, more than 50% of patients will experience lethal metastatic recurrence.
