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TOPAZ-1 Trial OS Data

Understanding IMFINZI treatment for your patients with biliary tract cancer (BTC)

IMFINZI (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).1

Be IN the know with IMFINZI’s TOPAZ-1 OS data

TOPAZ-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

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 chemotherapy2.

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† 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.

References:

  1. IMFINZI Product Monograph. AstraZeneca Canada Inc. February 20, 2026.
  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.

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