DELIVER: Real-World Data Analysis of Nivolumab Monotherapy in Advanced Gastric Cancer

2021 Year in Review - Gastrointestinal Cancer

Differences in survival time by tumor response were found during evaluation of nivolumab therapy in advanced gastric cancer.

Targeted immunotherapy is intensely studied in cancer research as the understanding of cancer biology and immunology are being unraveled.1 PD-1 is an inhibitory receptor expressed on activated T-cells that dampens the immune response.1 When T-cells bind to the PD-L1/PD-L2 ligands on tumor cells through PD-1 receptors, the T-cell function is impaired.1 Nivolumab, a monoclonal antibody, is a PD-1 immune checkpoint inhibitor that inhibits the interaction of the PD-1 receptor with its ligands.1 This action enhances antitumor activity, delays tumor growth, and facilitates tumor cell destruction.1 Nivolumab had a survival benefit when used as a third- or later-line treatment in patients with previously treated advanced gastric or gastroesophageal junction (GEJ) cancer in the phase 3 ATTRACTION-2 clinical trial. However, one concerning discovery is that after nivolumab treatment, some patients experience rapid tumor growth. It is not known for certain which proportions of patients will experience this phenomenon and what survival outcome they will experience. The DELIVER clinical trial sought to investigate the clinical outcomes of patients with advanced gastric cancer who were treated with nivolumab by using real-world data.

This multicenter, prospective observational study evaluated 487 patients with advanced gastric or GEJ adenocarcinoma who were treated with nivolumab alone. The DELIVER trial primary end point was overall survival (OS), with secondary end points of disease control rate (DCR), response rate, progression-free survival (PFS), tumor growth rate (TGR) at first evaluation, and drug safety. Subgroup analysis was also performed investigating survival based on tumor response and clinical factors. The median patient age was 70 years and 71% of patients were male. The 1-year survival rate was 30% and the median OS was 5.8 months. Median PFS was 1.8 months. The response rate was 14.2% in 282 patients who had measurable lesions. The DCR was 39.4%. The median OS and PFS by tumor response were not reached during the study.

Subgroup analysis found that OS was 6.5 months in male patients and 5.0 months in females. At enrollment, 42% of the patients had ascites and an OS of 3.7 months. Patients without ascites had an OS of 8.9 months. There were 219 patients who were evaluable for TGR. Of this group, 20.5% had hyperprogressive disease. The median OS from the first evaluation of patients with hyperprogressive disease was 2.8 months. For those without hyperprogressive disease, the median OS from first evaluation was 5.7 months.

These real-world data studies indicated comparable survival time to previous study results with the use of nivolumab to treat advanced gastric cancer.

Source: Kito Y, Inoue E, Akamaru Y, et al. Survival analysis by tumor response from real-world data in advanced gastric cancer treated with nivolumab: the DELIVER trial (JACCRO GC-08). J Clin Oncol. 2021;39(suppl_15):4044-4044.


  1. Guo L, Zhang H, Chen B. Nivolumab as programmed death-1 (PD-1) inhibitor for targeted immunotherapy in tumor. J Cancer. 2017;8:410-416.
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