HIMALAYA / STRIDE

Does tremelimumab plus durvalumab improve survival vs sorafenib in untreated unresectable HCC?

Population and treatment

1,171 patients randomized among STRIDE, durvalumab monotherapy and sorafenib.

Intervention vs comparator: STRIDE: tremelimumab 300 mg once + durvalumab 1,500 mg every 4 weeks vs sorafenib 400 mg twice daily.

Registry: https://pubmed.ncbi.nlm.nih.gov/?term=HIMALAYA+STRIDE+durvalumab+tremelimumab+HCC

Results

Median OS 16.43 vs 13.77 months; HR 0.78 (96.02% CI 0.65–0.93; p=0.0035). 3-year OS 30.7% vs 20.2%. Grade 3–4 treatment-emergent AEs 50.5% vs 52.4%.

Overall survival · 3 years

NNT: NCT03298451

NNH not calculated without defensible fixed-time excess-harm risk. Never derive NNT from median survival or HR alone.

Toxicity and treatment burden

20.2

Full grade 3–5 toxicity, discontinuation, QoL and treatment exposure require primary-report/supplement extraction before full clinical signoff. Missing rates are not imputed.

Interpretation and limitations

STRIDE showed OS superiority over sorafenib. Durvalumab monotherapy was non-inferior, not superior. Approximate NNT 10 at 3 years from fixed-time OS rates; consider hepatic reserve and immune hepatitis.

Distinguish prespecified from exploratory subgroups, mature from immature endpoints, and superiority from non-inferiority. Verify current guidelines and eligibility.

Primary source

Primary publication / authoritative source ↗

Source-level QoL, discontinuation, full toxicity and guideline currency audit remains a QC requirement.