TOPAZ-1
In untreated advanced biliary tract cancer, does durvalumab added to gemcitabine–cisplatin improve OS?
Trial design and population
Key results
Updated median OS was 12.8 months with durvalumab plus GemCis vs 11.5 months with GemCis alone (HR 0.80, 95% CI 0.66–0.97). At 24 months, OS was 23.6% vs 11.5%. Median PFS was 7.2 vs 5.7 months (HR 0.75).
Source-reported outcome visualization
Overall survival · 24 months
Bars are scaled to the larger reported group value; endpoint, unit and horizon are labelled. Values are source-reported, not estimated from medians.
Absolute Effect
Absolute 24-month OS gain 12.1 percentage points; NNT 9 based on 24-month OS.
NNT: 9 based on 24-month OS. Use only at the stated endpoint/time horizon; median survival differences are not converted into NNT.
NNH: Not quantifiable. Grade 3–4 adverse events were frequent in both groups due to GemCis; durvalumab adds immune-mediated events. Biliary infection, cytopenias, renal toxicity and immune hepatitis require monitoring.
Time-to-event hazard ratios and median survival are not treated as absolute risk differences. Where no defensible fixed-time NNT/NNH is available, the source-reported endpoint is visualized instead.
Safety and treatment burden
Grade 3–4 adverse events were frequent in both groups due to GemCis; durvalumab adds immune-mediated events. Biliary infection, cytopenias, renal toxicity and immune hepatitis require monitoring.
Follow-up, maturity and limitations
Follow-up: Updated analysis with follow-up approaching 2 years.
Most patients had ECOG 0–1 and adequate organ function. Evidence applies to advanced BTC not amenable to curative local treatment; molecular profiling remains important for later lines.
Clinical interpretation
Current-practice context · reviewed 20 October 2026
This page separates the original trial findings from contemporary treatment sequencing. Confirm current guidelines, local regulatory status, biomarker requirements, prior treatment exposure and patient-specific contraindications before applying the evidence. Historical comparators may no longer represent the current standard; subgroup findings and immature endpoints are labelled rather than generalized.