This phase 3 RCT (EMERALD-3) evaluated STRIDE (single-dose tremelimumab 300 mg + durvalumab 1500 mg, then durvalumab every 4 weeks), with or without lenvatinib, combined with TACE versus TACE alone in 760 adults with embolisation-eligible HCC not amenable to curative therapy, across 177 sites in 21 countries.
STRIDE + lenvatinib + TACE significantly improved median PFS vs TACE alone (13.0 vs 9.8 months; HR 0.70, 95% CI 0.57–0.86; p=0.0007), but median OS did not reach statistical significance (39.5 vs 34.7 months; HR 0.84, 95% CI 0.65–1.09; p=0.18). STRIDE + TACE also improved PFS vs TACE (12.9 vs 8.1 months; HR 0.71, 95% CI 0.56–0.91). Serious adverse events were more common in combination arms (64% and 51%) than TACE alone (23%); treatment-related deaths occurred in 7 (2%) patients on STRIDE + lenvatinib + TACE.
- OS data are immature (final analysis pending); the OS result did not reach statistical significance at interim analysis. - Open-label design with sponsor blinding only may introduce performance or assessment bias. - TACE technique and number of procedures were left to investigator discretion, introducing heterogeneity.
STRIDE + lenvatinib + TACE improves PFS in embolisation-eligible HCC and may represent a new combination option, but the OS benefit is not yet confirmed — clinicians should weigh this against a meaningfully higher serious adverse event burden (64% vs 23%) and treatment-related mortality risk before routine adoption.
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