A global phase III trial in the adjuvant setting comparing atezolizumab plus bevacizumab versus active surveillance. The primary endpoint was recurrence free survival after resection or ablation.
This IMbrave050 study included patients who received resection or ablation with a curative intent and those patients had high-risk features of recurrence. Those patients were randomised 1:1 to atezolizumab plus bevacizumab treatment or active surveillance which is the current standard of care. So no standard of care existed in the adjuvant setting. The treatment, atezolizumab plus bevacizumab, was continued for 12 months or 17 cycles, until disease recurrence or unacceptable toxicity. The primary endpoint was recurrence free survival assessed by an independent review facility. Also, patient-reported outcomes were measured. This is very important for this adjuvant setting.
The result was positive, the IMbrave050 trial met its primary endpoint of improvement of independent review facility assessed recurrence free survival with a hazard ratio of 0.72 and a p-value of 0.012. This result was met in the prespecified first interim analysis so the median recurrence free survival was not reached in both arms. The 12-month recurrence free survival rate is high in the treatment arm, 78% versus 65% in the surveillance arm. So this is a positive result.
Toxicity is manageable and, most importantly, patient reported outcomes were measured by using the EORTC QLQ-C30 reduced version and measured five domains that are health-related quality of life and four functioning – the role functioning, physical functioning and emotional functioning and social functioning. Those quality of life measures were not deteriorated from the baseline to 17 cycles, that is a very important finding in the adjuvant setting because those patients do not have cancer so this is an adjuvant and suppressed recurrence. So this PRO, patient reported outcome, data was very good.
How can these results impact the treatment of hepatocellular carcinoma?
This is the first positive trial that met the primary endpoint of improvement of recurrence free survival. So atezolizumab plus bevacizumab will be the standard of care for patients with HCC who received resection or ablation with curative intent. Hepatocellular carcinoma, HCC, is known to be very frequently recurring. So around 80% recurrence at five years after resection or ablation. So these are very important results so this should be a standard of care.