The National Institute for Health and Care Excellence (NICE) has recommended Bristol Myers Squibb’s (BMS) Opdivo (nivolumab) to treat adult patients with muscle invasive urothelial carcinoma (MIUC).
The treatment will be made available on the NHS specifically to those who are at high risk of recurrence following surgery, and whose tumours express PD-L1 at a level of 1% or more. The treatment is recommended on the condition that adjuvant treatment with platinum-based chemotherapy is unsuitable for the patient.
Urothelial cancer occurs in the cells which make up the inner lining of the bladder, urethra, ureter or renal pelvis, but typically in the bladder. This form of cancer accounts for over 90% of bladder cancer cases in the UK and is the eighth most common cancer in men. The condition can also occur in the renal pelvis or the ureter.
Invasive urothelial carcinoma is caused when cancerous cells spread past the lining into the surrounding bladder muscle. It is normally treated by surgery to completely remove the bladder, also known as radical resection. After surgery, over 50% of patients will experience lethal metastatic recurrence.
NICE’s decision was supported by results from the phase 3 CheckMate-274 clinical trial, which showed that after 11 months, survival rates for MIUC patients who were treated with Opdivo after surgery were 67.6%, compared to 46.3% for those who received placebo.
After a period of just under six months, Opdivo had a manageable safety profile, with 17.9% of patients in the Opdivo group experiencing adverse events of grade 3 or higher compared to 7.2% in the placebo group.
Analysis showed that a steady quality of life was maintained for patients receiving Opdivo versus placebo, as measured through the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire.