Bristol Myers Squibb Announces FDA Approval of Opdivo as First and Only PD-1 Inhibitor for Adjuvant Treatment of High-Risk Muscle-Invasive Urothelial Carcinoma

On August 20, Bristol-Myers Squibb (BMS) announced that the U.S. FDA has approved Opdivo (nivolumab) as adjuvant therapy for patients with urothelial carcinoma (UC) at high risk of recurrence following radical resection, regardless of prior neoadjuvant chemotherapy, PD-L1 status, or lymph node metastasis.

Opdivo is the first and only PD-1 inhibitor approved for the adjuvant treatment of urothelial carcinoma, and is currently approved for early-stage disease in three cancer types.

The FDA's approval was based on data from the Phase III CheckMate-274 study, which showed that the median disease-free survival (DFS) for patients receiving Opdivo was nearly 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).

In patients with tumor PD-L1 expression ≥1%, median DFS was not reached with Opdivo (95% CI: 21.2 - NE; n=140) versus 8.4 months in the placebo group (95% CI: 5.6 - 21.2; n=142), with Opdivo reducing the risk of disease recurrence or death by 45% (HR: 0.55, 95% CI: 0.39 - 0.77; P = 0.0005).

The results of the CheckMate-274 trial serve as the confirmatory trial for Opdivo’s FDA accelerated approval indication, which was granted accelerated approval by the FDA in February 2017 for patients with locally advanced or metastatic urothelial carcinoma (UC) who have disease progression during or following platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. The CheckMate-274 trial will support the full approval of this indication.

Professor Matthew D. Galsky, principal investigator of the CheckMate-274 trial, stated: "This approval is a significant milestone for patients who have undergone surgery to remove the bladder or part of the urinary tract and require additional treatment to reduce the risk of UC recurrence. Based on the safety and efficacy results from CheckMate-274, Opdivo offers a new FDA-approved therapy that reduces the risk of disease recurrence or death, potentially establishing a new standard of care for these patients."