medwireNews: Nivolumab significantly prolongs survival, versus placebo, in heavily pretreated patients with unresectable gastric or gastro-esophageal junction cancer, ATTRACTION-2 study findings indicate.
Narikazu Boku (National Cancer Center Hospital, Tokyo, Japan) and co-researchers say their results suggest that nivolumab “might be a new treatment option” for these patients, who currently have no standard of care therapy available and typically have poor prognosis.
The researchers randomly assigned 493 patients with advanced gastric or gastro-esophageal junction cancer who had been previously been treated with two or more chemotherapy regimens to receive the programmed cell death protein 1 inhibitor nivolumab 3 mg/kg intravenously (n=330) or placebo (n=163) every 2 weeks until progressive disease or toxicity requiring permanent discontinuation.
They found that, during nearly 9 months of follow-up, median overall survival was significantly longer in the nivolumab group than in the placebo group, at 5.26 versus 4.14 months, respectively. This was equivalent to a significant 27% lower risk for death with nivolumab during follow-up.
At 6 months, the estimated overall survival rates were 46.1% and 34.7% for patients receiving nivolumab and placebo, respectively, while the corresponding 12-month rates were 26.2% and 10.9%.
Patients in the nivolumab group also had a 40% reduced risk for disease progression compared with those in the placebo group, with median progression-free survival times of 1.61 and 1.45 months, respectively.
The objective response rate was 11.2% among patients treated with nivolumab but 0% among those treated with placebo, with a median time to response of 1.61 months and median response duration of 9.53 months among those patients with a confirmed response to treatment.
Boku et al comment that the safety profile of nivolumab “was manageable and similar to that reported in patients with other advanced solid tumours.”
They conclude that “nivolumab could be a standard-of-care treatment option and [the results] support ongoing assessment of nivolumab, alone and in combination with other treatments in earlier lines of therapy, in patients with advanced gastric or gastro-oesophageal junction cancer.”
Commenting on the findings in The Lancet, Ian Chau, from the Royal Marsden Hospital in Sutton, UK, says the ATTRACTION-2 data indicate that “targeting [programmed cell death ligand 1] checkpoint inhibition is a valid approach in improving survival for patients with advanced gastric or oesophagogastric adenocarcinoma.”
He adds: “Nivolumab might represent a new treatment option for patients as a third-line and subsequent line therapy for advanced gastric cancer in which a considerable unmet clinical need exists, but ultimately valid biomarkers to refine patient population and cost-effectiveness analysis would be required for overall societal value.”
Chau also cautions that the results might not apply to non-Asian patients, but Boku and team point out that trials investigating nivolumab for advanced gastric or gastro-esophageal junction cancer in various settings, including non-Asian patients, and as earlier treatment lines are already underway.
By Laura Cowen
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