Multicenter phase 3 trial of camrelizumab plus CAPOX with camrelizumab-based maintenance as initial treatment for G/GEJ adenocarcinoma

A randomized phase 3 trial at 75 centers in China evaluated camrelizumab lus CAPOX followed by camrelizumab plus apatinib maintenance (camre+CAPOX-camre+apa), compared with CAPOX alone, and with camrelizumab plus CAPOX followed by camrelizumab maintenance (camre+CAPOX-camre) as initial treatment for HER2-negative, unresectable, locally advanced or metastatic gastric or gastro-esophageal junction (G/GEJ) adenocarcinoma. A total of 885 patients were randomized 2:2:1. The primary endpoint was overall survival (OS) with camre+CAPOX-camre+apa versus CAPOX alone in the PD-L1 positive population (combined positive score > 1; n=592) and in the overall population. OS was longer with camre+CAPOX-camre+apa than with CAPOX alone in the PD-L1 positive population (median 15.0 versus 12.5 months; HR 0.80; p=0.02) and in the overall population (median 13.5 versus 12.1 months; HR 0,80; p=0.004). Use of camre+CAPOX-camre also showed longer OS versus CAPOX alone in the PD-L1 positive population (median 15.3 versus 12.5 months; HR 0.76; p=0.01) and in the overall population (median 14.2 versus 12.1 months; HR 0.80; p=0.02). No overall survival benefit was seen with camre+CAPOX-camre+apa versus camre+CAPOX-camre. Treatment-related adverse events of grade ≥ 3 occurred in 67.9% of patients with camre+CAPOX-camre+apa, 45.3% of patients with CAPOX alone, and 46.9% of patients with camre+CAPOX-camre. The authors conclude that intitial treatment with camrelizumab plus CAPOX followed by camrelizumab-based maintenance was associated with longer OS than CAPOX alone in HER2-negative, unresectable, locally advanced or metastatic G/GEJ adenocarcinoma.