In CheckMate 577, Nivolumab ( Opdivo ) has demonstrated a significant and clinically meaningful improvement in disease-free survival ( DFS; primary endpoint ) versus placebo and was well tolerated in patients with resected ( R0 ) stage II/III esophageal or gastroesophageal junction cancer ( EC/GEJC ) who received neoadjuvant chemoradiotherapy and had residual pathologic disease.
Median desease-free survival doubled with Nivolumab vs Placebo ( 22.4 vs 11.0 months; hazard ratio, HR 0.69; 96.4% CI 0.56–0.86; P = 0.0003 ).
Serious treatment-related adverse events ( TRAEs ) and TRAEs leading to discontinuation were reported for less than 10% of patients with Nivolumab and 3% with Placebo.
Patients were randomized 2:1 to Nivolumab 240 mg or Placebo once every 2 weeks ( Q2W ) for 16 weeks, followed by Nivolumab 480 mg or Placebo once every 4 weeks ( Q4W ).
Additional efficacy, safety, and quality-of-life ( QoL ) data from CheckMate 577 were presented.
794 patients were randomized ( Nivolumab, 532; Placebo, 262 ).
Distant recurrence was reported for 29% vs 39% and locoregional recurrence for 12% vs 17% of patients in the Nivolumab vs Placebo groups, respectively.
Median distant metastasis-free survival was 28.3 vs 17.6 months with Nivolumab vs Placebo ( HR 0.74; 95% CI 0.60–0.92 ).
Median progression-free survival 2 ( PFS2; time from randomization to progression after subsequent systemic therapy, initiation of second subsequent systemic therapy, or death, whichever is earlier ) was not reached with Nivolumab vs 32.1 months with Placebo ( HR 0.77; 95% CI 0.60–0.99 ).
Results for the FACT-ECS and FACT-G7 showed similar trends for QoL improvement from baseline for Nivolumab and Placebo during treatment and maintained benefit post-treatment.
In conclusion, adjuvant Nivolumab has demonstrated clinically meaningful efficacy, an acceptable safety profile, and maintained QoL, providing further support for its use as a new standard of care for patients with resected esophageal or gastroesophageal junction cancer who received neoadjuvant chemoradiotherapy with residual pathologic disease. ( Xagena )
Source: American Society of Clinical Oncology ( ASCO ) Annual Meeting, 2021