Innovent and Eli Lilly Present Results of P-Ib Study of Tyvyt (sintilimab) + Byvasda (biosimilar, bevacizumab) for Advanced Hepatocellular Carcinoma at ASCO GI 2022

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The P-Ib study included dose-escalation & expansion stages evaluates sintilimab (200mg) + bevacizumab biosimilar in 50 patients with LA or metastatic HCC
The results showed the 34% ORR (17/50) & (31% & 38%) for 7.5/15mg/kg (low/high-dose), 78% DCR (39/50), PFS (10.5mos.), m-OS (20.2mos.). In biomarker analysis, patients with a high level of CD137 ≥ 31.8 pg/mL have longer PFS with m-PFS (14.2mos. vs 4.1mos.), mOS (NR vs 15.6mos.) & TiME analysis showed that the high density of M1 macrophages in the stroma was related to higher efficacy, longer PFS & OS
The safety profile was consistent with previously reported studies of sintilimab & bevacizumab biosimilar with no new safety signals

Ref: PR Newswire | Image:Innovent