1,9 This is exciting news, providing renewed hope.” 2,3,7 In the CheckMate -577 trial, we saw a doubling in median disease-free survival compared to placebo, which suggests that Opdivo could become a new standard of care for these patients. 3,4,5,6,7,8 “Even after neoadjuvant CRT followed by surgery, there may be a high risk of recurrence for patients who do not achieve a pathologic complete response. Endowed Chair of Immunology at Baylor University Medical Center. ![]() ![]() Kelly M.D., MBA., director, Baylor Scott & White Charles A. “Locally advanced esophageal and gastroesophageal junction cancers are aggressive tumor types that often require multiple approaches to address the disease, including chemotherapy, radiation and surgery,” said Ronan J. 1 In an exploratory analysis, among patients with adenocarcinoma (n=563, 70.9%), mDFS was 19.4 months (95% CI: 15.9 to 29.4) with Opdivo versus 11.1 months (95% CI: 8.3 to 16.8) with placebo (unstratified HR 0.75 95% CI: 0.59 to 0.96), and among squamous cell carcinoma patients (n=230, 29%), mDFS was 29.7 months (95% CI: 14.4 to NE) with Opdivo versus 11.0 months (95% CI: 7.6 to 17.8) with placebo (unstratified HR 0.61 95% CI: 0.42 to 0.88). 1 Opdivo reduced the risk of disease recurrence or death by 31% compared to placebo (Hazard Ratio 0.69 95% CI: 0.56 to 0.85 P=0.0003). In the trial, among patients who received Opdivo, median disease-free survival (DFS) was twice as long as in those who received placebo (22.4 months : 16.6 to 34.0] compared to 11.0 months ). 1 The approval is based on results from the Phase 3 CheckMate -577 trial that evaluated Opdivo (n=532) compared to placebo (n=262) in esophageal or GEJ cancer patients with residual pathologic disease following neoadjuvant CRT and complete resection. Food and Drug Administration (FDA) has approved Opdivo ® (nivolumab, injection for intravenous use) for the adjuvant treatment of completely resected esophageal or gastroesophageal junction (GEJ) cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT). ![]() PRINCETON, N.J.-(BUSINESS WIRE)- Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. In CheckMate -577, Opdivo doubled median disease-free survival versus placebo for these patients 1Īpproval expands the role of Opdivo in earlier stages of disease, with two indications in the adjuvant setting across three types of cancer 1 Opdivo is the first and only immunotherapy approved in this patient population
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