Dr Teng on the Implications of Data From the CARES-005 Trial of TACE Plus Camrelizumab/Rivoceranib in HCC  

“Our study provided very strong evidence. Many radiologists may feel strange, because we only reported 3.2 months [with TACE alone], and the median PFS is usually like 10 months [with this approach]. [This may be attributed to our greater] use of RECICL criteria, physicians’ decisions, and… [the fact that] more than 40 patients had tumor thrombosis…”

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

 showed that the investigational combination regimen (n = 100) significantly improved median progression-free survival (PFS) to 10.8 months (95% CI, 8.8-13.7) compared with 3.2 months (95% CI, 2.4-4.2) with TACE alone (n = 100; HR, 0.34; 95% CI, 0.24-0.50; 

Teng notes that the median PFS of 3.2 months with TACE alone may seem surprising given that the median PFS with TACE in other studies is typically approximately 10 months. This outcome is partially attributed to the study design and patient characteristics, he states. Many patients were already experiencing disease progression prior to study inclusion, leading to a shorter effective treatment time, Teng explains. Additionally, the use of the Response Evaluation Criteria in Cancer of the Liver (RECICL) for assessment influenced the reported PFS, he notes.

Moreover, the study population included a substantial number of patients with advanced disease, such as those with tumor thrombosis, larger tumors over 7 cm in diameter, and poor prognosis, Teng says. This underscores the importance of early intervention with combination therapies for patients with late-stage disease, as they are more likely to benefit from the regimen, Teng asserts. The data suggest that for patients with advanced disease, particularly those with alcohol-related liver disease or those with later-stage disease, combined treatment regimens could be a critical approach to improve outcomes, he notes.

Based on these findings, future investigations will likely aim to better define the benefits of combining TACE with immunotherapy and antiangiogenic therapy in patients with advanced-stage disease, particularly those with more severe disease, Teng concludes.

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Gao-Jun Teng, MD, contextualizes efficacy data with TACE plus camrelizumab and rivoceranib in HCC from the phase 2 CARES-005 trial.

Dr Teng on the Implications of Data From the CARES-005 Trial of TACE Plus Camrelizumab/Rivoceranib in HCC

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; 

 < .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.

Gao-Jun Teng, MD, discusses findings from the phase 2 CARES-005 trial of TACE plus camrelizumab and rivoceranib vs TACE alone in patients with unresectable HCC.

Gao-Jun Teng, MD

Articles

Dr Teng on the Implications of Data From the CARES-005 Trial of TACE Plus Camrelizumab/Rivoceranib in HCC

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