Miguel Bronchud, Co-Founder at Regenerative Medicine Solutions, shared a post on LinkedIn:
“Non resectable hepatocellular carcinoma remains essentially ‘orphan of optimal systemic therapies’? And localized treatment is only ‘marginally effective’? A nasty cancer, in most advanced cases incurable?
Disappointing phase III comparative studies recently reported at the European Society of Medical Oncology (‘gastrointestinal cancers’) 2026.
Findings from the EMERALD-1 and EMERALD-3 studies suggest that further evidence of benefit is needed and to reflect on the use of surrogate endpoints, particularly in embolisation-eligible disease?
A lack of clear overall survival (OS) benefit, the absence of mature OS data and high rates of toxicity highlight more questions than answers in phase III EMERALD trials in patients with embolisation-eligible disease according to mixed findings presented at the ESMO Gastrointestinal Cancers Congress 2026 (Munich, 1–4 July).
In a final analysis of phase III EMERALD-1 trial, durvalumab with or without bevacizumab and transarterial chemoembolisation (TACE) did not improve OS compared with TACE alone in 616 patients with unresectable embolisation-eligible hepatocellular carcinoma (eeHCC) (Abstract 183O).
Probably more encouraging data were presented from the phase III EMERALD-3 study of tremelimumab plus durvalumab in the ‘STRIDE’ regimen (single-dose tremelimumab with regular-interval durvalumab) with or without lenvatinib plus TACE in 760 patients with eeHCC, with continued improvements observed in progression-free survival (PFS) at a second data cutoff, and a trend towards improved OS also reported (LBA2). But we should also wait for longer follow up and comparative overall survival outcomes.
In EMERALD-1, median OS was 29.9 months versus 33.3 months (hazard ratio [HR] 1.10; 95% confidence interval [CI] 0.87–1.39; p=0.470) for durvalumab plus bevacizumab plus TACE versus TACE, and 33.6 months versus 33.3 months (HR 0.93; 95% CI 0.74–1.19; p=0.666) for durvalumab plus TACE versus TACE, with consistent results reported across pre-specified subgroups.
‘The OS data from EMERALD-1 are disappointing since the previously reported benefit in PFS with the TACE combination (15.0 months with durvalumab plus bevacizumab versus 10.0 months with durvalumab and 8.2 months with TACE alone did not translate into prolonged OS (Lancet. 2025;405:216–232),’ states Prof. Jens Ricke from University Hospital, LMU, Munich, Germany, suggesting that there may not be a role for the durvalumab plus bevacizumab plus TACE regimen in patients with unresectable eeHCC.
The trade-off in terms of toxicity should also be considered when reviewing the efficacy data: without prolonged OS benefits the PFS benefit is probably not worth the high rate of adverse events(AEs) patients experienced?”
Other articles featuring Miguel Bronchud on OncoDaily.