Adapted from Oh DY, et al. 2022.2 OS data are from a planned interim analysis. Since the trial reached statistical significance for the primary objective on the basis of this prespecified interim analysis, results are considered the final, formal statistical analysis for overall survival. At data cutoff (August 11, 2021), the median duration of follow-up was 16.8 months (95% CI 14.8-17.7) in the IMFINZI + gem-cis group and 15.9 months (95% CI 14.9-16.9) in the placebo + gem-cis group.
TOPAZ-1 PHASE III TRIAL: Randomised, double-blind, placebo-controlled, multicentre, Phase III trial in patients with previously untreated locally advanced or metastatic intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder cancer. Patients who developed recurrent disease >6 months after surgery and/or completion of adjuvant therapy were eligible. Patients were randomised 1:1 to receive IMFINZI 1500 mg (n=341) or placebo (n=344) on Day 1 + gem-cis on Days 1 and 8 Q3W for up to 8 cycles followed by IMFINZI 1500 mg or placebo Q4W until disease progression or unacceptable toxicity. Primary endpoint was OS.2
Adapted from Oh DY, et al. 2022.2 Progression-free survival was determined by investigator assessment.2
TOPAZ-1 PHASE III TRIAL: Randomised, double-blind, placebo-controlled, multicentre, Phase III trial in patients with previously untreated locally advanced or metastatic intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder cancer. Patients who developed recurrent disease >6 months after surgery and/or completion of adjuvant therapy were eligible. Patients were randomised 1:1 to receive IMFINZI 1500 mg (n=341) or placebo (n=344) on Day 1 + gem-cis on Days 1 and 8 Q3W for up to 8 cycles followed by IMFINZI 1500 mg or placebo Q4W until disease progression or unacceptable toxicity. Primary endpoint was OS.2
- Grade 3/4 AEs occurred in 75.7% of patients on IMFINZI + gem-cis and 77.8% of patients on gem-cis alone2
- In the IMFINZI + gem-cis and gem-cis groups, the most common Grade 3/4 treatment-related AEs observed in >5% of patients were neutrophil count decrease (20.7% and 25.4%, respectively), neutropenia (19.2% and 20.2%), anaemia (18.9% and 18.7%), platelet count decrease (8.0% and 7.6%), white blood cell count decrease (4.1% and 5.8%), and thrombocytopenia (3.6% and 5.3%)2
- Discontinuation rates due to AEs were 13.0% with IMFINZI + gem-cis and 15.2% with gem-cis alone2
- The most common AEs were anaemia (48.2%), nausea (40.2%), constipation (32.0%) and neutropenia (31.7%) in the IMFINZI + gem-cis group; and anaemia (44.7%), nausea (34.2%), and decreased neutrophil count (31.0%) in the gem-cis group2
IMMUNE-MEDIATED AES WERE CONSISTENT WITH THE KNOWN SAFETY PROFILE OF IMFINZI¹,²
- Most immune-mediated AEs were Grade 1 or 22
- Grade 3/4 events occurred in 2.4% (8/338) of patients on IMFINZI + gem-cis and 1.5% (5/342) of patients on gem-cis alone2
TOPAZ-1 PHASE III TRIAL: Randomised, double-blind, placebo-controlled, multicentre, Phase III trial in patients with previously untreated locally advanced or metastatic intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder cancer. Patients who developed recurrent disease >6 months after surgery and/or completion of adjuvant therapy were eligible. Patients were randomised 1:1 to receive IMFINZI 1500 mg (n=341) or placebo (n=344) on Day 1 + gem-cis on Days 1 and 8 Q3W for up to 8 cycles followed by IMFINZI 1500 mg or placebo Q4W until disease progression or unacceptable toxicity. Primary endpoint was OS.2
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AE, adverse event; BTC, biliary tract cancer; CI, confidence interval; DCO, data cutoff; EASL, European Association for the Study of the Liver; gem-cis, gemcitabine-cisplatin; HR, hazard ratio; mPFS, median progression-free survival; mOS, median overall survival; mo, months; OS, overall survival; Q3W, every 3 weeks; Q4W, every 4 weeks; RWE, real-world evidence.
References: 1. IMFINZI® Approved Product Information. 2. Oh DY et al. N Engl J Med 2022;1(8):DOI: 10.1056/EVIDoa2200015 (including Supplementary Appendix). 3. KEYTRUDA (pembrolizumab) Approved Product Information. 4. Kelley RK et al. Lancet 2023;401(10392):1853-1865. 5. Oh DY et al. Four-year survival and safety analysis from the phase 3 TOPAZ-1 study of durvalumab plus chemotherapy in biliary tract cancer. Presented at: 2026 Liver Cancer EASL Summit; January 22-24, 2026; Edinburgh, UK. 6. Oh D-Y et al. J Hepatol 2025;83:1092-1101.
IMFINZI® is a registered trademark of the AstraZeneca group of companies. Registered user AstraZeneca Pty. Ltd. ABN 54 009 682 311. 66 Talavera Road, Macquarie Park, NSW 2113. www.astrazeneca.com.au. For Medical Information enquiries or to report an adverse event or product quality complaint: Telephone 1800 805 342 or via https://contactazmedical.astrazeneca.com.BC.
PBS Information: Authority required (STREAMLINED) for NSCLC. Refer to PBS Schedule for full authority information. PLEASE CLICK HERE TO REVIEW FULL PRODUCT INFORMATION BEFORE PRESCRIBING. ▼ This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. AE: adverse event; BICR: Blinded Independent Central Review; CI: confidence interval; CRT: chemoradiation therapy; HR: hazard ratio; irAE: immune-related adverse event; NSCLC: non-small cell lung cancer; OS: overall survival; PFS: progression-free survival; RECIST: Response Evaluation Criteria in Solid Tumors. References: 1. Girard N, et al. J Thorac Oncol 2023;18:181-193. 2. Spigel DR, et al. J Clin Oncol 2022;1301-1311. 3. Antonia SJ, et al. N Engl J Med 2017;377:1919-1929. IMFINZI® is a registered trademark of the AstraZeneca group of companies. Registered user AstraZeneca Pty. Ltd. ABN 54 009 682 311. 66 Talavera Road, Macquarie Park, NSW 2113. https://www.astrazeneca.com.au. For Medical Information enquiries or to report an adverse event or product quality complaint: Telephone 1800 805 342 or via https://contactazmedical.astrazeneca.com or email Medical Information enquiries to medinfo.australia@astrazeneca.com. AU-15640 ASTR0828/EMBC Date of preparation: January 2023. |