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. “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. “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. 55.5% of patients who received placebo, while grade 3 or 4 TRAEs were observed in 17.9% vs. Treatment-related adverse events (TRAEs) occurred in 77.5% of patients who received Opdivo vs. The safety profile of Opdivo was consistent with previously reported studies in patients with solid tumors. In patients whose tumors express PD-L1 =1%, median NUTRFS was not reached with Opdivo vs. 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). 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 the CheckMate -274 trial, patients who received nivolumab lived almost twice as long without their disease recurring compared to those treated with placebo. “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. 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. 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. 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 0.70, 98.31% Confidence Interval : 0.54 – 0.89, p<0.001). ![]() CheckMate -274 is the first positive phase 3 trial evaluating an immunotherapy in the adjuvant setting of muscle-invasive urothelial carcinoma. Wednesday, February 10, 2021, 17:30 Hrs īristol 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. Click hereīristol Mayer’s Phase 3 CheckMate -274 trial of Opdivo demonstrates statistically significant and clinically meaningful improvement in DFS in muscle-invasive urothelial carcinoma You can get e-magazine links on WhatsApp.
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