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Sintilimab plus a bevacizumab biosimilar (IBI305) vs sorafenib in unresectable hepatocellular carcinoma (ORIENT-32): A randomised, open-label, phase 2–3 study

The Lancet Oncology Jun 19, 2021

Ren Z, Xu J, Bai Y, et al. - Researchers tested sintilimab (a PD-1 inhibitor) plus IBI305, a bevacizumab biosimilar, vs sorafenib as a first-line therapy for unresectable hepatitis B virus (HBV)-associated hepatocellular carcinoma, in this phase 2–3 ORIENT-32 study. Patients were given intravenous sintilimab (200 mg every 3 weeks) plus intravenous IBI305 (15 mg/kg every 3 weeks), in the phase 2 part of the study. In phase 3 part, patients were randomized (2:1) to receive either sintilimab plus IBI305 (sintilimab–bevacizumab biosimilar group) or sorafenib (400 mg orally twice daily; sorafenib group), until disease advancement or unacceptable toxicity. A significant overall survival and progression-free survival benefit was shown to be conferred by sintilimab plus IBI305, vs sorafenib, along with an acceptable safety profile when administered as first-line treatment for Chinese patients with unresectable, HBV-associated hepatocellular carcinoma. This combination regimen could be a novel therapeutic choice for such patients.

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