Opdivo Gets FDA Nod as Adjuvant Therapy for Muscle-Invasive Urothelial Cancer

Opdivo (nivolumab) is a programmed death receptor-1 (PD-1) blocking antibody that has been approved by the FDA approved for the treatment of a variety of cancers, including patients with locally advanced or metastatic urothelial carcinoma that meet the following criteria:have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

In late August, the FDA approved a new indication for Opdivo for the adjuvant treatment of patients with urothelial carcinoma who are at high risk of recurrence after undergoing radical resection, regardless of prior neoadjuvant chemotherapy, nodal involvement, or PD-L1 status.

Adjuvant therapy is follow-up treatment after the initial treatment. Tecentriq (atezolizumab) and Keytruda (pembrolizumab)

The FDA’s go-ahead was based on the phase III CheckMate 274 study, which was a multicenter, double-blind, randomized, controlled trial that examined the role of adjuvant treatment with Opdivo therapy in high-risk, muscle-invasive urothelial carcinoma after radical surgery.There were 353 patients assigned to receive Opdivo 240 mg intravenously and 356 to receive placebo every two weeks for up to one year.Additionally, the primary endpoints of the study were disease-free survival among all the patients in the intention-to-treat (ITT) population and among study participants with a tumor programmed death ligand 1 (PD-L1) expression level of > 1%.An ITT population means that all the results of the patients randomized were included in the analysis, which is more reflective of what occurs in clinical practice.The secondary end point was survival free from recurrence outside the urothelial tract.

The median disease-free survival in the ITT population was 20.8 months with Opdivo and 10.8 months with placebo. The proportion of patients who were alive and disease-free at six months was 74.9% with Opdivo and 60.3% with placebo. Among patients with a PD-L1 expression of > 1%, the percentage of patients alive in the Opdivo group was 74.5% and 55.7% in the placebo group. The percentage of patients who were alive and free from recurrence outside the urothelial tract at six months was 77% with Opdivo compared with 62.7% in the placebo group. Treatment-related adverse events of grade 3 (severe) or higher occurred in 17.9% of the Opdivo group patients and 7.2% of the placebo group study participants.