Salvage therapy with nivolumab was efficacious among patients with advanced or recurrent gastric or gastroesophageal junction (GEJ) cancer who had failed 2 or more prior chemotherapy regimens, according to a study being presented at the 2017 Gastrointestinal Cancers Symposium.1
Prognosis is poor in this patient population. Nivolumab has demonstrated safety and efficacy in a variety of tumor types; researchers therefore evaluated nivolumab as salvage therapy after failure of standard chemotherapy among patients with advanced gastric cancer.
For the multicenter, double-blind, phase 3 trial (ClinicalTrials.gov Identifier: NCT02267343), investigators enrolled 493 patients aged 20 years or older with unresectable advanced or recurrent advanced gastric or GEJ cancer refractory to or intolerant of 2 previous chemotherapy regimens. Participants were randomly assigned 2:1 to receive intravenous nivolumab or placebo every 2 weeks until unacceptable toxicity or disease progression.
Nivolumab reduced the risk of death by 37% compared with placebo (hazard ratio [HR], 0.63; 95% CI, 0.50-0.78; P < .0001). Median overall survival was 5.32 months with nivolumab vs 4.14 months with placebo.
At 6 months, 46.4% of patients in the nivolumab arm were alive compared with 34.7% of those in the placebo group. Nearly 27% of patients given nivolumab were alive at 12 months vs 10.9% of those who received placebo.
Nivolumab-treated patients had a 40% reduced risk of progression or death compared with patients in the placebo arm (HR, 0.60; 95% CI, 0.49-0.75; P < .0001); median progression-free survival was 1.61 and 1.45 months, respectively.
RELATED: Adding Everolimus to Paclitaxel Not Effective for Advanced Gastric Cancer
In the nivolumab arm, 11.2% (95% CI, 7.7-15.6) of patients achieved an overall response.
Nivolumab was generally well tolerated, with 11.5% of patients experiencing grade 3 or higher treatment-related adverse events and 2.7% discontinuing immunotherapy due a drug-related adverse event of any grade.
- Kang YK, Satoh T, Ryu MH, et al. Nivolumab (ONO-4538/BMS-936558) as salvage treatment after second or later-line chemotherapy for advanced gastric or gastro-esophageal junction cancer (AGC): A double-blinded, randomized, phase III trial. J Clin Oncol. 2017;35(suppl):4S. Abstract 2.