O1-4 Survival time of nivolumab treatment in advanced gastric cancer from real-world data of the DELIVER trial (JACCRO GC-08)

Nivolumab (Nivo) has demonstrated survival benefit in previously treated gastric cancer (GC) patients (pts); however, there are few real-world data of Nivo. This trial was a prospective, multicenter, observational study which assessed pts with advanced gastric or gastroesophageal junction adenocarcinoma treated with Nivo alone and ECOG PS 0-2 (UMIN000030850). The aims were to evaluate the efficacy and safety of Nivo treatment in real world. Primary endpoint was overall survival (OS), secondary endpoints were response rate (RR), disease control rate (DCR), progression-free survival (PFS), tumor growth rate (TGR) at 1st evaluation, and safety. The data was fixed at the timepoint of 1 year after the last enrollment. In 501 pts enrolled from Mar 2018 to Aug 2019, 487 pts were evaluable (median age 70y, 71% male, ECOG PS0/1/2 42%/44%/14%, no. of prior regimen 1/2/≥3 2%/39%/59%, 21% HER2-pos, 42% pts with ascites). Median OS was 5.77 months (m) (95%CI 5.37-6.97) with 1y-survival rate of 30%, and median PFS was 1.83m (95%CI 1.73-2.00). The RR and DCR were 8.6% and 39.4%, respectively. In 282 pts with measurable lesions, the RR was 14.2% (95%CI 10.3-18.8). Sub-group analyses by patient background showed shorter median OS in some groups: PS2 (2.57m), albumin of <3.5 (4.30m), LDH of ≥245 (3.93m), histology of sig (4.13m), peritoneal metastases (4.93m), or ascites (3.72m). The TGR decreased after introduction of Nivo in 124 (56.6%) of 219 evaluable pts for TGR; however, 20.5% pts were identified as experiencing hyper-progressive disease (HPD). OS from 1st evaluation of pts with HPD was shorter compared to non-HPD, but it was not worse than pts with PD. Some common adverse events (AEs) were observed more frequently than previous reports but no unexpected immune-related AEs occurred. The real-word data demonstrated comparable survival outcomes of Nivo in advanced GC to a previous trial and the OS was worse in pts with some clinical factors.