Nivolumab Efficacious as Salvage Therapy for Advanced Gastric Cancer
Salvage therapy with nivolumab was efficacious among patients with advanced or recurrent gastric or gastroesophageal junction cancer.
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.
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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.