Trial results for the Phase 3b study investigating atezolizumab in combination with bevacizumab for patients with unresectable hepatocellular carcinoma were posted on ClinicalTrials.gov on 2025-05-08. The study reported a median overall survival of 24.8 months in Spanish patients not previously treated with systemic therapy.
Background
The study investigated atezolizumab and bevacizumab in patients with hepatocellular carcinoma (HCC) that was unresectable or unsuitable for locoregional treatments and who had not received prior systemic therapy. This combination regimen was evaluated in a Spanish patient population.
Trial design
The study (NCT04732286) was a Phase 3b, one-arm, multicenter, open-label study that enrolled 100 participants in Spain. The trial investigated atezolizumab in combination with bevacizumab in patients with unresectable or unsuitable for locoregional treatments hepatocellular carcinoma who had not been previously treated with systemic therapy. The primary objective was to evaluate the safety of the combination, with secondary objectives including efficacy assessments.
Key results
The trial results provided several efficacy and safety measurements for the atezolizumab and bevacizumab combination:
- Median Overall Survival (OS) was 24.8 months (95% Confidence Interval).
- Median Progression-free Survival (PFS) was 9.3 months (95% Confidence Interval).
- The Objective Response Rate (ORR) was 24.2% (95% Confidence Interval) of participants.
- Median Time to Progression (TTP) was 11.2 months (95% Confidence Interval).
- Median Duration of Response (DOR) was 15.9 months (95% Confidence Interval).
- Regarding safety, 19 participants discontinued atezolizumab and/or bevacizumab due to adverse events of Grade ≥ 3.
- The percentage of participants who started second-line treatment was 24.2%.
- Mean change from baseline in International Normalized Ratio (INR) was 1.1 (Standard Deviation: 0.1) and 0.1 (Standard Deviation: 0.0) INR of prothrombin time.
- Mean change from baseline in Albumin-Bilirubin (ALBI) Score was -2.7 (Standard Deviation: 0.4) and 0.4 (Standard Deviation: 0.4) score.
- The percentage of participants with ascites and/or hepatic encephalopathy was 17%.
What this means
The results from this Phase 3b study provide insights into the safety and efficacy profile of atezolizumab plus bevacizumab in Spanish patients with unresectable or unsuitable for locoregional treatments hepatocellular carcinoma. The reported median overall survival of 24.8 months and objective response rate of 24.2% offer important data for clinicians managing this patient population. The safety data, including the rate of discontinuation due to Grade ≥ 3 adverse events, also contributes to the understanding of the treatment's tolerability in a real-world setting.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04732286, titled "A Study of Atezolizumab in Combination With Bevacizumab in Spanish Patients With Unresectable or Unsuitable for Locoregional Treatments Hepatocellular Carcinoma Not Previously Treated With Systemic Therapy," were posted on 2025-05-08 on clinicaltrials.gov.