Why consider IMFINZI for your BTC patients?
IMFINZI + GEM-CIS: THE 1st IO COMBINATION TO EXTEND OVERALL SURVIVAL BEYOND GEM-CIS IN ADVANCED BTC1-4*
*mOS 12.8 months with IMFINZI + gem-cis vs 11.5 months with gem-cis (HR 0.80; 95% CI 0.66-0.97; P=0.021) (primary endpoint)2
See the TOPAZ-1 primary analysis & 4-year update
REAL-WORLD ANALYSIS CONSISTENT WITH TOPAZ-1 KEY FINDINGS2,5
Retrospective analysis was not part of TOPAZ-1 and cannot be used to draw comparative conclusions5
See the real-world efficacy & safety data
PLEASE CLICK HERE TO REVIEW FULL PRODUCT INFORMATION BEFORE PRESCRIBING.
FURTHER INFORMATION AVAILABLE ON REQUEST FROM ASTRAZENECA ON 1800 805 342.
PBS INFORMATION: Authority required (STREAMLINED). Refer to PBS Schedule for full authority information
BTC, biliary tract cancer; CI, confidence interval; gem-cis, gemcitabine-cisplatin; HR, hazard ratio; IO, immuno-oncology; mOS, median overall survival; mo, months; OS, overall survival; 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. 3. KEYTRUDA (pembrolizumab) Approved Product Information. 4. Kelley RK et al. Lancet 2023;401(10392):1853-1865. 5. Rimini M et al. Eur J Cancer 2024;208:114199.
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.
IMFINZI is now indicated for locally advanced or metastatic biliary tract cancer (BTC) in combination with gem-cis1
The first immunotherapy combination to extend overall survival beyond gem-cis*1,2
*Median OS 12.8 months with IMFINZI + gem-cis vs 11.5 months with gem-cis alone (HR 0.80; 95% CI 0.66–0.97; p=0.021).1,2
Similar rates of adverse reactions occurred with IMFINZI + gem-cis and gem-cis alone in the TOPAZ-1 trial:2
- Grade 3/4 AEs occurred in 75.5% of patients on IMFINZI and 77.8% of patients on placebo.2
- Discontinuation rates due to AEs were 13.0% with IMFINZI and 15.2% with placebo.2
Immune-mediated AEs were consistent with the known safety profile of IMFINZI:1,2
- Most immune-mediated AEs were Grade 1 or 2.2
- Grade 3/4 events occurred in 2.4% of patients on IMFINZI and 1.5% of patients on placebo.2
IMFINZI for BTC Patient Access Program
AstraZeneca is providing IMFINZI to eligible patients living with biliary tract cancer through a Patient Access Program (PAP). See below for how to enrol your patients and for other IMFINZI resources.
Click here to enrol your patients into the IMFINZI for BTC Patient Access Program
PBS INFORMATION: IMFINZI is not listed on the PBS for biliary tract cancer. |
PLEASE CLICK HERE TO REVIEW FULL PRODUCT INFORMATION BEFORE PRESCRIBING.
FURTHER INFORMATION AVAILABLE ON REQUEST FROM ASTRAZENECA.
 |
This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting-problems. |
Abbreviations: AE: adverse event; BTC: biliary tract cancer; CI: confidence interval; gem-cis: gemcitabine plus cisplatin; HR: hazard ratio; OS: overall survival; PAP: Patient Access Program. References: 1. IMFINZI® (durvalumab) Approved Product Information. 2. Oh DY et al. New Engl J Med Evid 2022;1(8). 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 or email Medical Information enquiries to medinfo.australia@astrazeneca.com.
Date of preparation: August 2023. AU-17136.
