Nivolumab in adjuvant setting
The results of a third trial presented at the ESMO meeting suggest a role for nivolumab in the adjuvant setting, following neoadjuvant chemoradiation therapy in patients with resected esophageal or GEJ cancer.
This was the CheckMate 577 trial, which compared adjuvant nivolumab with placebo in 794 patients from across the globe.
Nivolumab significantly increased median disease-free survival to 22.4 months versus 11.0 months with placebo (HR, 0.69, P = .0003).
Treatment-related adverse events leading to discontinuation were reported in 9% of nivolumab patients versus 3% on placebo, reported Ronan J. Kelly, MD, chief of oncology at Baylor Scott & White Health in Dallas.
Interestingly, patient-reported health status on the EQ-5D-3L visual analogue scale (VAS) and utility index were similar between nivolumab- and placebo-treated patients, with both groups experiencing clinically meaningful improvements.
Dr. Kelly said this is “the first adjuvant therapy to provide a statistically significant and clinically meaningful improvement” in patients with esophageal cancer or GEJ cancer following neoadjuvant chemoradiation.
Consequently, the results “represent the first advance in years for this group of patients, potentially establishing adjuvant nivolumab as a new standard of care.”
However, the invited discussant raised several issues with the trial design. Preoperative chemoradiation is not “universally accepted” as the standard of care in this setting, disease-free survival is not currently validated as a major endpoint in gastroesophageal cancers, and the median follow-up was short, commented Andrés Cervantes, MD, PhD, University of Valencia (Spain), and president-elect of ESMO.
In addition, there was no differentiation between esophageal squamous cell and adenocarcinoma histologies.
Nevertheless, CheckMate 577 is the first positive adjuvant study for checkpoint inhibitors in gastrointestinal tumors and, crucially, the results “are independent of PD-L1 status,” Dr. Cervantes said.
CheckMate 649 was funded by Bristol-Myers Squibb. ATTRACTION-4 was funded by Ono Pharmaceutical and Bristol-Myers Squibb. CheckMate 577 was funded by Bristol-Myers Squibb. Many of the presenters reported relationships with pharmaceutical companies.
This article first appeared on Medscape.com.