Bristol Myers Squibb (BMS) has reported positive three-year follow-up results from its phase 3 trial of Opdivo (nivolumab) in certain patients with urothelial carcinoma, the most common type of bladder cancer.
Urothelial carcinoma, which most frequently begins in the cells that line the inside of the bladder, accounts for approximately 90% of bladder cancer cases.
The majority of urothelial carcinomas are diagnosed at an early stage, but rates of recurrence and disease progression are high and around 50% of patients who undergo radical surgery will experience disease recurrence.
The latest results from BMS’ CheckMate-274 trial demonstrate significant sustained clinical benefits with Opdivo for the adjuvant treatment of patients with muscle-invasive urothelial carcinoma at a high risk of recurrence after radical resection.
At a median follow-up of 36.1 months, Opdivo more than doubled the average length of time patients lived without disease recurrence, demonstrating a median disease-free survival of 22 months compared to 10.9 months with placebo.
Additionally, those treated with Opdivo showed a median non-urothelial tract recurrence-free survival (NUTRFS) of 25.9 months compared to 13.7 months for placebo and, in patients whose tumour cells expressed PD-L1 of 1% and over, median NUTRFS was 52.6 months with Opdivo versus 8.4 months with placebo.
Benefits were also seen across exploratory endpoints, including distant metastasis-free survival and second progression-free survival (defined as the time from randomisation to disease progression after subsequent next-line systemic therapy, start of second subsequent next-line systemic therapy or death).
Dana Walker, vice president, development programme lead, genitourinary cancers at BMS, said: “The durable follow-up results from CheckMate -274 continue to fuel our excitement toward our ongoing research in earlier stages and its potential to change outcomes for patients.
“We look forward to closely following the CheckMate -274 trial, which is ongoing to assess additional key secondary endpoints, including overall survival to which we currently remain blinded.”
Opdivo is currently approved in more than 65 countries, including the US, EU, Japan and China for a range of indications such as melanoma, lung, kidney and gastric cancers.
In November 2022, the drug was recommended by the National Institute of Health and Care Excellence (NICE) as a first-line treatment, alongside chemotherapy, for rare forms of advanced gastroesophageal cancer.