Recently, Bristol-Myers Squibb (BMS) announced that the US FDA has approved Opdivo (nivolumab) as an adjuvant treatment for patients with urothelial cancer (UC) who have a high risk of recurrence after radical resection, regardless of whether these patients have previously received neoadjuvant chemotherapy, What is the status of PD-L1 and whether there is lymph node metastasis.

Opdivo is the first and only PD-1 inhibitor approved for adjuvant treatment of urothelial cancer, and it has been approved for the early stage of three cancers.

The FDA approval is based on data from the Phase III CheckMate-274 study. The results show that the median disease-free survival (DFS) of patients treated with Opdivo is almost twice that of the placebo group: 20.8 months (95% CI: 16.5- 27.6) vs 10.8 months (95% CI: 8.3 -13.9). Compared with placebo, Opdivo reduced the risk of disease recurrence or death by 30% (HR: 0.70, 95% CI: 0.57-0.86; P=0.0008).

Among patients with tumors expressing PD-L1 ≥ 1%, the median DFS of Opdivo did not reach (95% CI: 21.2-NE; n=140), and it was 8.4 months in the placebo group (95% CI: 5.6-21.2; n =142), Opdivo reduced the risk of disease recurrence or death by 45% (HR: 0.55, 95% CI: 0.39-0.77; P = 0.0005).

The result of the CheckMate-274 trial is a confirmatory trial for Opdivo to obtain accelerated FDA approval for the indication. This indication was approved by the FDA in February 2017 for disease progression during or after platinum-containing chemotherapy or in platinum-containing chemotherapy Patients with locally advanced or metastatic UC with disease progression within 12 months after neoadjuvant or adjuvant therapy. The CheckMate-274 trial will support the full approval of this indication.

Professor Matthew D. Galsky, the main investigator of CheckMate-274, said: “This approval is an important milestone for patients who have undergone surgery to remove the bladder or secretory urethra and require additional treatment to reduce the risk of UC recurrence. Based on CheckMate- As a result of the safety and effectiveness of 274, Opdivo provides a new FDA-approved therapy that can reduce the risk of disease recurrence or death, and may become a new standard of care for such patients."