IMFINZI

What it is

IMFINZI is a concentrated solution for intravenous infusion containing durvalumab, available in vials of 120 mg or 500 mg. It is a sterile, preservative-free, clear to opalescent solution that is colourless to slightly yellow.

Approved indications

— IMFINZI in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by IMFINZI as monotherapy after surgery, for adults with resectable (tumours ≥4 cm and/or node positive) non-small cell lung cancer with no known epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements. — IMFINZI for patients with locally advanced, unresectable non-small cell lung cancer whose disease has not progressed following platinum-based chemoradiation therapy. — IMFINZI as monotherapy for adult patients with limited-stage small cell lung cancer whose disease has not progressed following platinum-based chemoradiation therapy. — IMFINZI in combination with etoposide and either carboplatin or cisplatin for first-line treatment of patients with extensive-stage small cell lung cancer. — IMFINZI in combination with gemcitabine and cisplatin for patients with locally advanced or metastatic biliary tract cancer. — IMFINZI in combination with tremelimumab for adult patients with unresectable hepatocellular carcinoma who have not received prior treatment with a PD-1/PD-L1 inhibitor. — IMFINZI in combination with carboplatin and paclitaxel, followed by IMFINZI monotherapy, for first-line treatment of patients with primary advanced or recurrent endometrial cancer. — IMFINZI in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by IMFINZI as monotherapy adjuvant treatment after radical cystectomy, for adults with muscle invasive bladder cancer. — IMFINZI in combination with FLOT chemotherapy as neoadjuvant and adjuvant treatment, followed by adjuvant IMFINZI monotherapy, for adults with resectable gastric or gastroesophageal junction adenocarcinoma.

Dosing overview

IMFINZI is administered as an intravenous infusion over one hour. Dosing varies by indication and ranges from 1120 mg to 1500 mg for combination therapy regimens and 10 mg/kg every two weeks or 1500 mg every four weeks for monotherapy, with treatment duration depending on the specific indication and clinical response. No dose reduction or escalation for IMFINZI is recommended.

Key safety warnings

Immune checkpoint inhibitors, including durvalumab, can cause severe and fatal immune-mediated adverse drug reactions affecting any organ system, which may manifest during or after discontinuation of treatment. Immune-mediated pneumonitis or interstitial lung disease, including fatal cases, occurred in patients receiving durvalumab in clinical trials. In the PACIFIC study, pneumonitis or radiation pneumonitis occurred in 33.9% of IMFINZI-treated patients and 24.8% of placebo patients, including Grade 3 in 3.4% on IMFINZI versus 3.0% on placebo and Grade 5 in 1.1% on IMFINZI versus 1.7% on placebo. Immune-mediated hepatitis, including a fatal case, occurred in patients receiving durvalumab in clinical trials. Immune-mediated colitis occurred in patients receiving durvalumab in clinical trials. Immune-mediated myocarditis, which can be fatal, occurred in patients receiving IMFINZI or IMFINZI in combination with tremelimumab. In the NIAGARA study for resectable muscle-invasive bladder cancer, a higher overall incidence of venous thromboembolic events, including pulmonary embolism and thrombosis, was observed in patients treated with durvalumab in combination with chemotherapy (15.7%) compared to chemotherapy alone (10.5%), with fatal cases of pulmonary embolism reported. In the MATTERHORN study for resectable gastric or gastroesophageal junction adenocarcinoma, a higher overall incidence of pulmonary embolism was observed in patients treated with durvalumab in combination with FLOT chemotherapy (4.2%) compared to FLOT chemotherapy alone (1.9%), with fatal cases reported.

Contraindications

IMFINZI is contraindicated in patients with hypersensitivity to durvalumab or to any of the excipients listed in the product information.

PBS listing

IMFINZI solution concentrate for intravenous infusion 120 mg is listed on the PBS as a streamlined authority-required item with an ex-manufacturer price of A$860.99.

Regulatory history

IMFINZI durvalumab was first registered on the ARTG on 1 October 2018 for the 500 mg strength and 2 October 2018 for the 120 mg strength. In November 2019, PBAC recommended IMFINZI for non-small cell lung cancer (unresectable Stage III, non-progressed after platinum-based chemoradiation therapy) with a streamlined authority-required listing. In November 2020, PBAC recommended IMFINZI for small cell lung cancer, and in March 2022 recommended an amendment to allow fixed-dose 1500 mg every four weeks dosing for Stage III non-small cell lung cancer. In July 2023, PBAC recommended IMFINZI for biliary tract cancer. An AusPAR was published on 19 June 2023 for IMFINZI in combination with tremelimumab for unresectable hepatocellular carcinoma in patients who have not received prior PD-1/PD-L1 inhibitor treatment. In November 2024, PBAC recommended durvalumab for deficient mismatch repair endometrial cancer with a streamlined authority-required listing. In May 2025, PBAC recommended IMFINZI for first-line treatment of patients with advanced unresectable hepatocellular carcinoma who have not received prior treatment or are intolerant to tyrosine kinase inhibitors.