Dr Teng on the Phase 2 CARES-005 Study of TACE Plus Camrelizumab and Rivoceranib in Unresectable HCC

“[Findings, in terms of] the primary end point of PFS, showed that the median [value] was 10.8 months for TACE plus camrelizumab and rivoceranib [compared with] only 3.2 months for TACE alone, which is statistically significant.”

Gao-Jun Teng, MD, of Zhongda Hospital, Medical School, Southeast University, discusses findings from the phase 2 CARES-005 trial (NCT04559607) examining transarterial chemoembolization (TACE) plus camrelizumab and rivoceranib vs TACE alone in patients with unresectable hepatocellular carcinoma (HCC).

CARES-005 enrolled patients with confirmed HCC that was not amenable to curative treatment, with no extrahepatic metastasis, at least 1 measurable lesion per Response Evaluation Criteria in Cancer of the Liver (RECICL), a Child-Pugh score of A, and an ECOG performance status of 0 or 1. Eligible patients were randomly assigned 1:1 to receive TACE in combination with camrelizumab and rivoceranib or TACE alone. The primary end point was PFS per RECICL criteria. Secondary end points included progression-free survival (PFS) per modified RECIST criteria, duration of response, overall survival (OS), and safety.

In the intention-to-treat population, patients in the investigational arm (n = 100) experienced a median PFS of 10.8 months (95% CI, 8.8-13.7) per RECICL criteria compared with 3.2 months (95% CI, 2.4-4.2) in the control arm (n = 100; HR, 0.34; 95% CI, 0.24-0.50; P < .0001). These data reached statistical significance, Teng notes. Additionally, despite a limited number of OS events, the median OS was 24.0 months (95% CI, 18.7-30.1) compared with 21.5 months (95% CI, 15.6-not reached), respectively (HR, 0.87; 95% CI, 0.57-1.32). Investigators believe that the final data will show a very good OS benefit with TACE plus camrelizumab and rivoceranib compared with TACE alone, Teng concludes.

In terms of safety, the profile of the combination was manageable and consistent with the known adverse effects reported with the individual agents in this population.