Five-year overall survival (OS) and OS by tumour response measures from the Phase 3 HIMALAYA study of tremelimumab plus durvalumab in unresectable hepatocellular carcinoma (uHCC)

Background: In the Phase 3 HIMALAYA study (NCT03298451) in uHCC, STRIDE (Single Tremelimumab Regular Interval Durvalumab) significantly improved OS vs sorafenib in the primary analysis (Abou-Alfa et al. NEJM Evid 2022). Here, we report the first 5-year OS analysis in uHCC.

Methods: Participants (pts) with uHCC were randomised to STRIDE, durvalumab monotherapy or sorafenib. OS, 5-year OS rates, OS by disease control (DC), changes in tumour size and depth of response (DpR) and serious adverse events (SAEs) were assessed. Extended long-term survivors were described.

Results: The OS hazard ratio for STRIDE vs sorafenib was 0.76 (95% confidence interval, 0.65–0.89). The 5-year OS rate was 19.6% with STRIDE vs 9.4% with sorafenib and was further improved in pts who achieved DC (28.7% vs 12.7%). OS rates for pts who achieved≥G2 (>25%) tumour shrinkage were 58.0% (57 pts at risk) vs 36.0% (8 pts at risk) at 48 months and 50.7% (34 pts at risk) vs 26.3% (4 pts at risk) at 60 months for STRIDE vs sorafenib, respectively. The rate of treatment-related SAEs with STRIDE did not change from the primary analysis.

Conclusions: STRIDE demonstrated an unprecedented 5-year survival rate, with no additional serious safety events in the extended follow-up. The improved OS outcomes observed across multiple tumour response evaluations, including DC and DpR, provide novel insights on the clinical benefit of dual immune checkpoint inhibition beyond conventional measures of response.

Previously presented at ESMO Congress 2024, ”FPN (Final Publication Number): 947MO”, ”Lorenza Rimassa et al.” – Reused with permission

Publication History

Article published online:
20 January 2025