Abstract 991P
Background
A phase II/III study, is being conducted to evaluate the efficacy and safety of sintilimab, a PD-1 blockade, plus IBI305, a bevacizumab biosimilar, comparing with sorafenib as first-line treatment for advanced HCC (NCT03794440).
Methods
In phase II, the safety run-in part, adults with advanced or metastatic HCC (histologically diagnosed or clinical diagnosed for cirrhosis per AASLD guideline) were enrolled to receive sintilimab (200 mg IV Q3W) plus IBI305 (15 mg/kg IV Q3W). The primary endpoint is safety profile. In phase III part, following the same inclusion and exclusion criteria, it is planned to enroll 546 pts. Eligible patients were randomized (2:1) to receive sintilimab (200 mg IV Q3W) plus IBI305 (15 mg/kg IV Q3W) or sorafenib (400 mg orally, BID). The primary endpoints are OS and PFS by IRC per RECIST 1.1. The phase III part is ongoing and patient enrollment has completed. We reported the results from phase II part herein.
Results
As of Feb 3rd, 2020, 24 pts were enrolled in phase II part. With a median treatment duration of 9.2 months, 18 (75%) pts experienced TRAEs. Grade ≥ 3 TRAEs were reported in 6 (25%) pts, including proteinuria (3 [12.5%]), hepatic function abnormal (2 [8.3%]), hyperthyroidism (1 [4.2%]) and immune-mediated hepatitis (1 [4.2%]). No TRAE resulted in treatment discontinuation and death. With a median follow-up of 9.0 months, the median OS was not reached and the 6-month OS rate was 87.1%. The median PFS was 8.4 months (95% CI, 5.6, not reached) and the 6-month PFS rate was 60.9%. The ORR assessed by the investigator per RECIST 1.1 was 25.0% and DCR was 83.3%.
Conclusions
The data from phase II part showed acceptable safety profile and promising efficacy of sintilimab plus IBI305 as first-line treatment for advanced HCC.
Clinical trial identification
NCT03794440.
Editorial acknowledgement
Legal entity responsible for the study
Innovent Biologics, Inc. Innovent Biologics, Inc.
Funding
Innovent Biologics, Inc.
Disclosure
Y. Yang, Y. Wang, H. Zhou, M. Chen: Full/Part-time employment: Innovent Biologics, Inc.. All other authors have declared no conflicts of interest.