Adding nivolumab to adjuvant chemotherapy does not improve relapse-free survival (RFS) in patients with gastric or gastroesophageal junction (GEJ) cancer, according to research presented at the ASCO Annual Meeting 2023. 

These results come from the phase 3 ATTRACTION-5 study ( Identifier: NCT03006705). The study enrolled patients from Japan, Korea, Taiwan, and China who had pathologic stage III gastric/GEJ cancer after a D2 or more extended gastrectomy. 

Patients were randomly assigned to receive adjuvant chemotherapy and either nivolumab at 360 mg every 3 weeks (n=377) or placebo (n=378). Planned treatment was completed by 61.5% of patients in the nivolumab arm and by 71.4% of patients in the placebo arm. 

Continue Reading

The primary endpoint was RFS per blinded independent central review, and it was not met. The 3-year RFS rate was 68.4% in the nivolumab arm and 65.3% in the placebo arm (hazard ratio [HR], 0.90; 95.72% CI, 0.69-1.18; P =.4363). 

Some subgroups showed HRs reflecting a potentially favorable RFS in the nivolumab arm, including patients with an ECOG performance status of 1, stage IIIC disease, and PD-L1-positive tumors. 

However, these results relate to relatively small numbers of patients and events, according to study presenter Masanori Terashima, MD, PhD, of Shizuoka Cancer Center in Nagaizumi, Japan. He added that additional analyses are needed to understand these findings. 

In an analysis of RFS per investigator, the 3-year RFS rate was 64.9% in the nivolumab arm and 59.3% in the placebo arm (HR, 0.87; 95% CI, 0.69-1.11). 

The 3-year overall survival rate was 81.5% in the nivolumab arm and 78.0% in the placebo arm (HR, 0.88; 95% CI, 0.66-1.17).

The rate of treatment-related adverse events (TRAEs) was 98.7% in the nivolumab arm and 97.3% in the placebo arm. The rate of serious TRAEs was 25.3% and 10.7%, respectively. The rate of TRAEs leading to discontinuation was 9.2% and 3.5%, respectively. The nivolumab arm had 1 pulmonary TRAE that proved fatal. 

Disclosures: This research was supported by Ono Pharmaceutical Co Ltd in collaboration with Bristol Myers Squibb. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.


Terashima M, Kang YK, Kim YW, et al. ATTRACTION-5: a phase 3 study of nivolumab plus chemotherapy as postoperative adjuvant treatment for pathological stage III (pStage III) gastric or gastroesophageal junction (G/GEJ) cancer. ASCO 2023. June 2-6, 2023. Abstract 4000.