US clears BMS' Opdivo as first adjuvant therapy for bladder cancer

Bristol Myers Squibb said Friday that the FDA has expanded Opdivo's (nivolumab) urothelial carcinoma (UC) indication to include adjuvant use in high-risk patients, regardless of prior neoadjuvant chemotherapy, nodal involvement or PD-L1 status. It said the decision was based on Phase III results from the CheckMate -274 trial, which also served as confirmatory evidence to convert the drug's 2017 accelerated approval in previously treated locally advanced or metastatic UC into a full approval.

"UC is the third type of cancer where Opdivo has been the first approved PD-1 inhibitor in the adjuvant setting," noted Adam Lenkowsky, who heads the company's US operations for cardiovascular, immunology and oncology. "Now with this advancement, we can offer new hope to the conversations between healthcare providers and their UC patients where historically no approved treatment options have existed to help prevent disease recurrence post-surgery."

Doubled disease-free survival

The CheckMate -274 study involved 709 patients who had undergone radical resection of UC originating in the bladder or upper urinary tract and were at high risk of recurrence. At 20.8 months, median disease-free survival (DFS) was nearly twice as long in patients treated with Opdivo, compared to 10.8 months for placebo. The immunotherapy was also associated with a 30% reduction in the risk of disease recurrence or death.

Among patients whose tumours express PD-L1 ≥1%, median DFS was not reached for those in the Opdivo group, compared to 8.4 months for placebo. Opdivo reduced the risk of disease recurrence or death in this population by 45%, the company said.