Adjuvant treatment with Opdivo shows statistically significant and clinically meaningful improvement in disease-free survival for muscle-invasive urothelial carcinoma in phase III CheckMate -274 trial.- BMS

Bristol Myers Squibb announced results from the Phase III CheckMate -274 trial , which showed that Opdivo (nivolumab) significantly improved disease-free survival (DFS) as an adjuvant treatment across all randomized patients with surgically resected, high-risk muscle-invasive urothelial carcinoma and in the subgroup of patients whose tumors express PD-L1 greater than 1%, meeting both of the study’s primary endpoints. CheckMate -274 is the first positive Phase III trial evaluating an immunotherapy in the adjuvant setting of muscle-invasive urothelial carcinoma. Across all randomized patients, Opdivo nearly doubled the average length of time patients lived without disease recurrence , demonstrating a median disease-free survival of 21.0 months compared to 10.9 months with placebo, a risk reduction of 30% (Hazard Ratio [HR] 0.70, 98.31% Confidence Interval [CI]: 0.54 – 0.89, p<0.001). in patients whose tumors express pd-l1 greater than 1%, opdivo reduced the risk of disease recurrence or death by 47%, with the median dfs not reached for opdivo vs. 10.8 months for placebo (hr 0.53, 98.87% ci: 0.34 – 0.84, p><0.001). these data will be featured in an oral presentation (abstract #391) at the american society of clinical oncology genitourinary cancers symposium, taking place virtually, on february 12, 2021 from 4:36 to 4:46 p.m. est. “people with muscle-invasive urothelial carcinoma often undergo major surgery to remove their bladders as a life-saving measure, but still face a probability of about 50 percent that their cancer will recur,” said dean bajorin, m.d., genitourinary oncologist, memorial sloan kettering cancer center. “in the checkmate -274 trial, patients who received nivolumab lived almost twice as long without their disease recurring compared to those treated with placebo. these clinically meaningful results have the potential to change the way physicians treat muscle-invasive urothelial carcinoma, helping address the pressing unmet need for efficacious, tolerable therapies following surgery.” opdivo also demonstrated improvements in key secondary endpoints , including non-urothelial tract recurrence-free survival (nutrfs), defined as the time that patients lived without disease recurrence outside of the bladder, ureters or renal pelvis. in all randomized patients, those treated with opdivo showed a median nutrfs of more than two years (24.6 months) compared to 13.7 months for placebo (hr 0.72, 95% ci: 0.58 – 0.89). in patients whose tumors express pd-l1 ?1%, median nutrfs was not reached with opdivo vs. 10.9 months with placebo (hr 0.54, 95% ci: 0.38 – 0.77). the safety profile of opdivo was consistent with previously reported studies in patients with solid tumors. treatment-related adverse events (traes) occurred in 77.5% of patients who received opdivo vs. 55.5% of patients who received placebo, while grade 3 or 4 traes were observed in 17.9% vs. 7.2% of patients, respectively.>