Abstract No : Abstract: #LBA6
Indication : Gastric Cancer, Gastroesophageal junction cancer and Esophageal Cancer
Intervention : Nivolumab
Company : Bristol-Myers Squibb
Technology : PD-1/PD-L1 inhibitor
1581 pts were concurrently randomized in nivo+chemo and chemo arms, including 955 pts (60%) with PD-L1 CPS ≥ 5. With aminimum follow-up of 12 months (mo), NIVO + chemo showed a statistically significant improvement in OS and PFS vs chemo in pts whose tumors expressed PD-L1 CPS ≥ 5 (OS, HR 0.71 [98.4% CI 0.59–0.86; P < 0.0001] and PFS, HR 0.68 [98% CI 0.56–0.81; P < 0.0001]). Statistically significant OS benefit was also observed in pts with PD-L1 CPS ≥ 1 and the all-randomized population. No new safety signals were identified. (Nivo+Chemo mOS: 14.4 mo, PFS: 7.7 mo, chemo: mOS: 11.1 mo, PFS: 6.1 mo)
NIVO is the first PD-1 inhibitor to demonstrate superior OS and PFS in combination with chemo vs chemo alone in previously untreated pts with advanced GC/GEJC/EAC, with a manageable safety profile. NIVO + chemo represents a potential newstandard 1L treatment option for these pts.