Immunotherapy for Previously Treated Advanced Gastric Cancer
In an Asian phase III trial (ONO-4538-12, ATTRACTION-2) reported in The Lancet, Kang et al found that nivolumab (Opdivo) produced an improvement in overall survival vs placebo in patients with advanced gastric or gastroesophageal junction cancer who had disease refractory to or who were intolerant of at least two previous chemotherapy regimens.
Study Details
In the double-blind trial, 493 patients from 49 sites in Japan, South Korea, and Taiwan were randomized 2:1 between November 2014 and February 2016 to receive nivolumab at 3 mg/kg (n = 330) or placebo (n = 163) every 2 weeks. The primary endpoint was overall survival in the intent-to-treat population. The study is ongoing but not recruiting new patients.
Overall Survival
At data cutoff (August 2016), median follow-up in surviving patients was 8.87 months in the nivolumab group and 8.59 months in the placebo group. Median overall survival was 5.26 months in the nivolumab group vs 4.14 months in the placebo group (hazard ratio = 0.63, P < .0001). Overall survival was 46.1% vs 34.7% at 6 months and 26.2% vs 10.9% at 1 year. Progression-free survival was 20.2% vs 6.8% at 6 months and 7.6% vs 1.5% at 1 year.
Adverse Events
Treatment-related adverse events of any grade occurred in 43% of the nivolumab group vs 27% of the placebo group, with grade 3 or 4 treatment-related adverse events occurring in 10% vs 4%. Serious treatment-related adverse events occurred in 10% vs 5% of patients, with those occurring in at least two patients in the nivolumab group consisting of interstitial lung disease, colitis, pyrexia, pneumonia, urinary tract infection, and diabetic ketoacidosis. Treatment-related adverse events led to death in five patients (2%) vs two patients (1%).
The investigators concluded: “In this phase 3 study, the survival benefits indicate that nivolumab might be a new treatment option for heavily pretreated patients with advanced gastric or gastro-oesophageal junction cancer. Ongoing trials that include non-Asian patients are investigating nivolumab for advanced gastric or gastro-oesophageal junction cancer in various settings and earlier treatment lines.”
The study was funded by Ono Pharmaceutical and Bristol-Myers Squibb.
Narikazu Boku, MD, of the National Cancer Center Hospital, Tokyo, is the corresponding author for The Lancet article.
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