Clinical Report: Post Hoc Evaluation of Durvalumab Combined with Chemotherapy

Overview

The post hoc analysis of the TOPAZ-1 trial indicates that durvalumab combined with gemcitabine and cisplatin significantly improves overall survival in patients with advanced biliary tract cancers.

Background

Advanced biliary tract cancers (aBTCs) have limited therapeutic options, with double chemotherapy regimens being the standard of care until recently. The TOPAZ-1 trial demonstrated that the addition of durvalumab to chemotherapy significantly enhances overall survival compared to placebo. Understanding the long-term effects and safety profiles of this combination is crucial for optimizing treatment strategies in this patient population.

Data Highlights

Key Findings

• Durvalumab plus GemCis resulted in a statistically significant improvement in overall survival (OS) compared to placebo plus GemCis (HR, 0.80; P = .02).
• The 24-month OS rate was 24.9% for the durvalumab group versus 10.4% for the placebo group.
• Safety profiles were comparable between the durvalumab and placebo groups.
• The benefit of durvalumab plus GemCis was sustained over a follow-up period of approximately 4 years.
• No detrimental effects on participant-reported quality-of-life outcomes were observed.

Clinical Implications

The findings support the use of durvalumab in combination with chemotherapy as a first-line treatment for patients with advanced biliary tract cancer. Clinicians should consider this regimen for eligible patients to improve survival outcomes.

Conclusion

The TOPAZ-1 trial's post hoc analysis provides evidence of the efficacy and safety of durvalumab combined with chemotherapy in advanced biliary tract cancer.

Related Resources & Content

1. Oh et al., JAMA Oncology, 2026 -- Durvalumab Plus Chemotherapy for Advanced Biliary Tract Cancer: A Post Hoc Analysis of the TOPAZ-1 Randomized Clinical Trial
2. The ASCO Post, 2026 -- TOPAZ-1 Post Hoc Analysis Supports Durvalumab Plus Chemotherapy in Advanced Biliary Tract Cancer
3. The ASCO Post, 2024 -- Addition of Durvalumab to Gemcitabine/Cisplatin in Advanced Biliary Tract Cancer: PROs in TOPAZ-1
4. The ASCO Post, 2022 -- Durvalumab Plus Gemcitabine/Cisplatin Improves Survival in Patients With Advanced Biliary Tract Cancer: TOPAZ-1 KEY POINTS
5. ESMO Clinical Practice Guideline interim update on the management of biliary tract cancer - PMC, 2026
6. the asco post — Chemoimmunotherapy for Advanced BTC: 3-Year Overall Survival Update From the TOPAZ Trial
7. ESMO Clinical Practice Guideline interim update on the management of biliary tract cancer - PMC
8. Durvalumab Plus Chemotherapy for Advanced Biliary Tract Cancer: A Post Hoc Analysis of the TOPAZ-1 Randomized Clinical Trial | Trials | JAMA Oncology | JAMA Network
9. First-Line Chemotherapy Regimens for Unresectable Locally Advanced or Metastatic Biliary Tract Cancer: A Systematic Review and Bayesian Network Meta-Analysis - PMC