Bristol Myers Squibb (BMS) announced the US Food and Drug Administration (FDAP has approved Opdivo (nivolumab, injection for intravenous use) for adjuvant treatment of completely resected esophageal or gastroesophageal junction (GEJ) cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT). The approval is based upon results from the recent Phase III CheckMate -577 trial, which evaluated the drug in comparison to placebo in esophageal or GEJ cancer patients with residual pathologic disease following neoadjuvant CRT and complete resection.
According to BMS, trial patients that received Opdivo in the trial exhibited median disease-free survival (mDFS) twice as long as in those who received placebo (22.4 months compared to 11 months. According to the trial results, Opdivo reduced the risk of disease recurrence or death by 31% compared to placebo.
In an exploratory analysis, among patients with adenocarcinoma, mDFS was 19.4 months with Opdivo versus 11.1 months with placebo. Also, among squamous cell carcinoma patients, mDFS was 29.7 months with Opdivo, compared to 11 months with placebo.
Ronan Kelly (director of the Baylor Scott and White Charles A Sammons Cancer Center, and W.W. Caruth Jr. Endowed Chair of Immunology at the Baylor University Medical Center) said, “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. 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. This is exciting news, providing renewed hope.”