Bristol Mayers Phase 3 CheckMate -274 Trial Of Opdivo Demonstrates Statistically Significant And Clinically Meaningful Improvement In DFS In Muscle-in

Bristol Myers Squibb announced results from the phase 3 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 =1%, meeting both of the study’s primary endpoints. CheckMate -274 is the first positive phase 3 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 =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 at the American Society of Clinical Oncology Genitourinary Cancers Symposium, taking place virtually, on February 12, 2021.“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.“By moving immunotherapy into earlier stages of cancer, we may have the chance to disrupt the course of the disease, reducing recurrence and leading to better outcomes for patients,” Dana Walker, M.D., M.S.C.E., vice president, development program lead, genitourinary cancers, Bristol Myers Squibb. “Opdivo-based therapy has now shown benefit not only as an adjuvant treatment in urothelial cancer, but also in earlier-stage melanoma, esophageal and lung cancer. We are excited for what the results of CheckMate -274 may mean for patients, and we thank the patients and investigators who participated in the trial. We look forward to working with regulatory authorities globally with the goal of bringing this treatment option to those who may benefit.”CheckMate -274 is a phase 3 randomized, double-blind, multi-center study evaluating Opdivo compared to placebo in patients with muscle-invasive urothelial cancer at a high risk of recurrence after radical surgery. Both patients who received and did not receive neoadjuvant chemotherapy prior to resection were eligible to participate in the study, and whether or not participants received neoadjuvant cisplatin treatment was a stratification factor. A total of 709 patients were randomized 1:1 to receive Opdivo 240 mg every two weeks or placebo for up to one year.The primary endpoints of the trial are DFS in all randomized patients (i.e. the intention-to-treat population) and in the subset of patients whose tumors express PD-L1 =1%. Key secondary endpoints include overall survival, non-urothelial tract recurrence free survival and disease-specific survival.Urothelial carcinoma, which most frequently begins in the cells that line the inside of the bladder, is the 10th most common cancer in the world, with approximately 550,000 new cases diagnosed annually. In addition to the bladder, urothelial carcinoma can occur in other parts of the urinary tract, including the ureters and renal pelvis. The majority of urothelial carcinomas are diagnosed at an early stage, but rates of recurrence and disease progression are high.More than 50% of patients who undergo radical resection for invasive urothelial carcinoma will experience disease recurrence. For patients whose disease recurs as metastatic cancer, the prognosis is poor, with a median overall survival of approximately 12 to 14 months when treated with systemic therapy.Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

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