Trial results for the combination of atezolizumab and bevacizumab in patients with unresectable hepatocellular carcinoma were posted on ClinicalTrials.gov on 2025-09-22. The study, NCT04487067, reported a median overall survival of 20.76 months for the combination therapy.
Background
The study, known as Amethista, investigated the safety and efficacy of atezolizumab in combination with bevacizumab for patients with unresectable hepatocellular carcinoma who had not received prior systemic treatment.
Trial design
The Amethista study (NCT04487067) was a Phase 3b, one-arm, multicenter, open-label trial. It enrolled 152 participants with unresectable hepatocellular carcinoma who had not been previously treated with systemic therapy. The study evaluated the combination of atezolizumab and bevacizumab.
Key results
Key results from the trial for the atezolizumab + bevacizumab combination arm included:
- Median Overall Survival (OS) was 20.76 months.
- Median Progression-free Survival (PFS) was 8.80 months.
- The Objective Response Rate (ORR) was 28.29 percentage of participants.
- Median Time to Progression (TTP) was 11.24 months.
- Median Duration of Response (DOR) was 17.35 months.
- Median Post-progression Survival (PPS) was 11.27 months.
- The number of participants with Treatment-Emergent Adverse Events (TEAEs) was 144 Participants.
- Regarding Grade 3-5 bleeding/haemorrhage events, the number of participants was reported as 17 Participants, 3 Participants, and 2 Participants.
- The number of participants reporting severe symptoms in the PRO-CTCAE Questionnaire was reported as 39 Participants and 33 Participants.
What this means
The results of this Phase 3b study provide efficacy and safety data for the atezolizumab + bevacizumab combination in patients with previously untreated, unresectable hepatocellular carcinoma. The observed median overall survival of 20.76 months, median progression-free survival of 8.80 months, and objective response rate of 28.29% offer insights into the potential clinical benefit of this regimen in this challenging patient population. The safety profile, including the reported incidence of treatment-emergent adverse events and Grade 3-5 bleeding, will be important for clinicians to consider.
Source
The information for this article was derived from trial results posted on ClinicalTrials.gov on 2025-09-22. The results pertain to study NCT04487067, titled "A Study of Atezolizumab (Tecentriq) in Combination With Bevacizumab to Investigate Safety and Efficacy in Patients With Unresectable Hepatocellular Carcinoma Not Previously Treated With Systemic Therapy-Amethista," available on clinicaltrials.gov.