Cinda's PD-1 first-line advanced liver cancer indication approved

On June 25, the NMPA official website showed that Cinda Bio's new indication for PD-1 Sintilimab was approved, and the indications are: combined with Dalitong (bevacizumab) for the first-line treatment of unresectable or metastatic liver Cell carcinoma

From NMPA official website

The marketing application for this new indication is based on the results of the ORIENT-32 study

The ORIENT-32 study is a comparison of the efficacy and safety of Daboshu® (sintilizumab injection) combined with Dayoutong® (bevacizumab injection) and sorafenib in the first-line treatment of advanced liver cancer A randomized, controlled, open multicenter phase III clinical study (NCT03794440)

From February 11, 2019 to January 15, 2020, a total of 595 patients were enrolled in the ORIENT-32 study, of which 24 patients in phase 2 were enrolled and received treatment, and a total of 571 patients in phase 3 were randomly assigned to the letter Dilimumab-bevacizumab group (n=380) or sorafenib group (n=191)

In the phase 2 study, 22 cases (92%) had adverse events related to any study drug, of which the incidence of grade 3-4 was 29%, and the incidence of serious adverse events related to any study drug was 6 cases (25 %), no adverse events leading to death occurred

As of the data cut-off date (August 15, 2020), the median follow-up time for the sintilimab-bevacizumab biosimilar group was 10.

The independent images are based on the PFS Kaplan–Meier graph evaluated by RECIST V1.

In the first interim analysis of overall survival, compared with sorafenib, the overall survival of sintilimab-bevacizumab biosimilars was also significantly improved (median value did not reach [95%CI] Reached – Not Reached] vs 10.

Kaplan–Meier Survival Curve of ITT Population

The most common adverse event during grade 3-4 treatment was hypertension (55 out of 380 patients in the sintilimab-bevacizumab biosimilar group (14%) vs.

Liver cancer is a common malignant tumor of the digestive system.