I’M IN with IMFINZI®
In first-line setting, locally advanced or metastatic BTC, consider Imfinzi in combination1*
Please click the links above or the images below to download resources and view support materials to help manage patients taking Imfinzi.
* Imfinzi used in combination with gemcitabine-based chemotherapy.
About ImfinziImfinzi (durvalumab for injection) in combination with gemcitabine-based chemotherapy is indicated for the treatment of patients with locally advanced or metastatic biliary tract cancer (BTC).
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Be IN the know with Imfinzi’s TOPAZ-1 OS dataTOPAZ-1: Interim OS analysis; 62% maturity
Imfinzi + chemotherapy demonstrated significant improvement vs placebo + chemotherapy in OS
(HR = 0.80, (95% CI: 0.66, 0.97), p=0.021)1
Kaplan-Meier curve of OS (interim-analysis)1
Adapted from the Imfinzi Product Monograph.
24.9% (95% CI, 17.9 to 32.5) of patients on Imfinzi + chemotherapy were alive at 24 months vs 10.4% (95% CI, 4.7 to 18.8) of patients on placebo + chemotherapy2
Imfinzi + chemotherapy reduced the risk of death by 20% vs. chemotherapy alone (HR=0.80; 95% CI, 0.66-0.97; p=0.021); event rate: 198/341 vs. 226/344 chemotherapy
† TOPAZ-1 was a randomized, double-blind, placebo-controlled, global phase III study of Imfinzi + gem-cis vs placebo + gem-cis in adults aged ≥ 18 years with histologically confirmed locally advanced or metastatic BTC and ECOG performance status of 0 or 1. Patients who developed recurrent disease more than 6 months after surgery and/or completion of adjuvant therapy were included. Patients must have had at least one target lesion by RECIST v1.1 and adequate organ and bone marrow function. Randomization was stratified by disease status and primary tumour location. Patients were randomized 1:1 to receive Imfinzi 1500 mg + gem-cis (n=341) or placebo + gem-cis (n=344). Patients received Imfinzi 1500 mg or placebo intravenously on Day 1 + gemcitabine 1000 mg/m2 and cisplatin 25 mg/m2 (each administered on Days 1 and 8) every 3 weeks (21 days) for up to 8 cycles, followed by Imfinzi 1500 mg or placebo, respectively, every 4 weeks, as long as clinical benefit was observed or until unacceptable toxicity. The primary endpoint was OS.
Nurse Kit Resources
imAR Handbook
High-level details concerning imAEs, how to recognize them, and how to manage them.
imAR Checklist
A concise checklist that allows you to run through potential imARs during your patient consultation.
Pocket Guide
A tool that you can carry with you at all times that provides an overview of imAEs and their management.
GP/Pharmacist ImAR Letter
To give to pharmacists and healthcare professionals in your centre/clinic so they can better understand the patient’s treatment and how to manage their potential side effects.
Patient Side Effects Tracker
Tear Pad
A tool for your patients to track and communicate their side effects in a clear and comprehensive table.
HCP Resources
PACIFIC Trail Paper
Antonia SJ, Villegas A, Daniel D, et al. Overall survival with durvalumab after chemoradiotherapy in Stage III NSCLC. N Engl J Med. 2018;379(24):2342-2350.
Reprint of the pivotal PACIFIC trial overall survival results, as published in the New England Journal of Medicine.
PACIFIC Postcard
Overview of the IMFINZI indication and its use in the PACIFIC Regimen.
For Patients
IMFINZI Note Card
A small card for patients to take notes when discussing their IMFINZI treatment plan.
Chemoradiation Therapy Postcard
An overview of the definitive platinum-based concurrent chemoradiation therapy (cCRT) regimens received by patients prior to their enrollment in the PACIFIC Study.
Clinical Efficacy and Dosing Guide
A review of IMFINZI clinical efficacy results from the PACIFIC trial, and recommended dosing and administration with adjustment guidance.
Dosing Guide
Provides information on the recommended dosing, preparation and administration of Imfinzi.
Imfinzi
Product Monograph
TOPAZ-1 Trial Paper
Oh DY, He Ar, Qin S, et al. Durvalumab plus gemcitabine and cisplatin in advanced biliary tract cancer. NEJM Evid. 2022;1(8):1-11. DOI: 10.1056/EVIDoa2200015.
Reprint of the pivotal TOPAZ-1 trial overall survival results, as published in NEJM Evidence.
BTC Canadian Experience
Provides a snapshot of the Canadian patients who received Imfinzi in combination with gemcitabine-based chemotherapy for the treatment of locally advanced or metastatic BTC.
Patient Resources
Patient Information and
Side Effects Brochure
Provides patients with key information about
Imfinzi treatment and how to recognize possible
side effects.
Patient Medication
Information
Provides patients with information on what Imfinzi
is used for, how it works and how it’s given as well
as important safety information.
Important Safety InformationClinical use:
The safety and efficacy of Imfinzi in patients younger than 18 years of age have not been established. Therefore, Health Canada has not authorized an indication for pediatric use.
No overall differences in safety or efficacy were reported between elderly patients (≥ 65 years of age) and younger patients (< 65 years of age) who received Imfinzi.
Contraindications:
Imfinzi is contraindicated in patients who are hypersensitive to durvalumab or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
Most serious warnings and precautions:
Immune-mediated adverse reactions: Imfinzi as monotherapy or in combination with other products can cause severe and fatal immune-mediated adverse reactions, including enterocolitis, intestinal perforation, hepatitis, dermatitis, Stevens-Johnson syndrome, endocrinopathy, pneumonitis, interstitial lung disease, myocarditis, neuropathy, encephalitis, myasthenia gravis, as well as toxicities in other organ systems. Immune-mediated adverse reactions have occurred at higher frequencies when Imfinzi is administered as a combination therapy with tremelimumab compared with Imfinzi as monotherapy.
Other relevant warnings and precautions:
- Administer under the supervision of health care professionals experienced in the treatment of cancer
- When using Imfinzi in combination with tremelimumab, consult the IMJUDO (tremelimumab) Product Monograph for further information on this drug
- Driving or operating machinery
- No clinical data available for Child-Pugh Class B and C in patients with unresectable hepatocellular carcinoma
- Infections
- Infusion-related reactions
- Monitoring and laboratory tests – AST, ALT, bilirubin, renal, and thyroid function
- Serious embolic events in combination with gemcitabine and cisplatin
- Fertility
- Pregnant and nursing women
- Elderly
For more information:
Please consult the Imfinzi Product Monograph for important information relating to adverse reactions, drug interactions and dosing, which have not been discussed in this piece.
The Product Monograph is also available by calling us at 1-800-668-6000.
Gem-cis = Gemcitabine-cisplatin.
References: 1. IMFINZI (AstraZeneca Canada Inc.) Product Monograph. July 17, 2025. 2. Oh DY, He Ar, Qin S, et al. Durvalumab plus gemcitabine and cisplatin in advanced biliary tract cancer.
NEJM Evidence. 2022. Doi: 10.1056/EVIDoa2200015.