AdvanTIG-203: Phase II randomized, multicenter study of ociperlimab (OCI) + tislelizumab (TIS) in patients (pts) with unresectable, locally advanced, recurrent/metastatic esophageal squamous cell carcinoma (ESCC) and programmed cell death-ligand 1 (PD-L1) positivity (ESMO 2023)
Table: 1020MO Efficacy O+T (n=62) P+T (n=63) ORRa, % (95% CI) INV b 30.6 (19.6, 43.7) 20.6 (11.5, 32.7) P c,d =0.2114 IRC e 32.3 (20.9, 45.3) 25.4 (15.3, 37.9) P c,d =0.4209 OS e,f (months), median (95% CI) 10.1 (7.1, NE) 9.3 (6.0, NE) HRc (95% CI): 0.93 (0.55, 1.58) P c,g =0.3977 PFS e (months), median (95% CI) INV 3.4 (1.8, 5.1) 3.5 (1.9, 4.1) HRc (95% CI): 0.93 (0.61, 1.43) IRC 3.6 (2.7, 5.1) 2.8 (1.9, 6.9) HRc (95% CI): 1.01 (0.64, 1.59) Median follow-up was 7 months. IRC, independent review committee; NE, not estimable aConfirmed per RECIST v1.1bPrimary endpoint cStratified d2-sided; by Cochran-Mantel-Haenszel method eSecondary endpoint fStill immature (event rate 45.6%) g1-sided; by log-rank test Conclusions In 2L therapy of advanced ESCC pts with PD-L1 TAP ≥10%, O+T showed tolerable safety profile and trend toward better ORR, but similar PFS vs. P+T.