FDA approves Opdivo for esophageal, gastroesophageal junction cancers
The FDA approved nivolumab as adjuvant treatment for certain patients with completely resected esophageal or gastroesophageal junction cancers, according to the agent’s manufacturer.
The approval applies to use of the agent by patients who have residual pathologic disease after neoadjuvant chemoradiotherapy and complete resection.
Nivolumab (Opdivo, Bristol Myers Squibb), a PD-1 inhibitor, is the first immunotherapy approved for this patient population.
The FDA based the approval on results of the randomized phase 3 CheckMate-577 trial, which included 794 patients with esophageal or gastroesophageal junction cancers who had pathologic disease after neoadjuvant chemoradiotherapy and complete resection.
Researchers in the double-blind, multicenter trial assigned 532 patients to adjuvant nivolumab dosed at 240 mg via IV infusion every 2 weeks for 16 weeks, followed by 480 mg via IV every 4 weeks. The other 262 patients received placebo. Treatment continued for up to 1 year, or until disease recurrence or unacceptable toxicity.
Investigator-assessed DFS served as the primary endpoint.
As Healio previously reported, patients assigned nivolumab achieved significantly longer median DFS (22.4 months vs. 11 months; HR = 0.69; 95% CI, 0.56-0.85).
Exploratory analyses showed statistically significant improvements in median DFS among patients with adenocarcinoma (19.4 months vs. 11.1 months; unstratified HR = 0.75; 95% CI, 0.59-0.96), as well as those with squamous cell carcinoma (29.7 months vs. 11 months; unstratified HR = 0.61; 95% CI, 0.42-0.88).
Twelve percent of patients assigned nivolumab discontinued treatment due to adverse events, and 28% required treatment delays for the same reason. One-third (33%) of patients experienced serious adverse events. One nivolumab-treated patient died of myocardial infarction. The most common adverse events included fatigue (34%), diarrhea (29%), nausea (23%), rash (21%), musculoskeletal pain (21%) and cough (20%).
“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,” Ronan J. Kelly, MD, MBA, director of Baylor Scott & White Charles A. Sammons Cancer Center and W.W. Caruth Jr. endowed chair of immunology at Baylor University Medical Center, said in a Bristol Myers Squibb-issued press release. “Even after neoadjuvant chemoradiotherapy followed by surgery, there may be a high risk [for] 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.”