SMC recommends Opdivo® (nivolumab) for use post-surgery in specific urothelial cancer patients
pharmafile | February 20, 2023 | News story | Business Services |
(Uxbridge, Middlesex, 13 February 2023) – The Scottish Medicines Consortium (SMC) has accepted Bristol Myers Squibb’s (BMS’) 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. 1 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, ureters or urethra. 4,5,6
“While for most patients with newly diagnosed bladder cancer the outlook is very favourable, there is a subgroup of patients who remain at very high risk of a potentially incurable relapse, even after complete surgical removal of the bladder,” said Professor Robert Jones, Professor of Clinical Cancer Research, University of Glasgow. “Today’s announcement means that some of those patients, those with elevated levels of a protein called PD-L1 in their cancer, will now be able to benefit from drug treatment with nivolumab immunotherapy, a treatment which may reduce the risk of recurrence of bladder cancer.”
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 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). 3
“We are really happy with today’s SMC recommendation as, until now, there was no adjuvant immunotherapy for muscle-invasive bladder cancer available in Scotland after surgery,” said Dr Lydia Makaroff, Chief Executive Officer of Fight Bladder Cancer. “This positive decision may have the potential to give hundreds of people living with muscle-invasive bladder cancer more quality time with their loved ones.”
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=351) and 7.2% in the placebo group (N=348). 2 Furthermore, exploratory analyses showed there was no deterioration in the quality of life of patients receiving nivolumab 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).2
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. 4,5,6 Approximately 1,460 people are diagnosed with bladder cancer in Scotland every year, and it is the 9 th most common cancer in men in Scotland. 7,8 Invasive urothelial carcinoma of the bladder is when cancerous cells spread beyond the lining into the surrounding bladder muscle and is often treated by surgery to completely remove the bladder (radical resection). 9,10 Following surgery, more than 50% of patients will experience lethal metastatic recurrence.2
“BMS is delighted to receive this SMC approval, which will provide additional options for people living with urothelial cancer in Scotland,” said Scott Cooke, General Manager, UK and Ireland at Bristol Myers Squibb. “Changing the outlook for people living with difficult-to-treat cancers is a priority for BMS. We will work collaboratively with our partners to help ensure access to nivolumab for all eligible patients in Scotland as soon as possible.”
