TECENTRIQ

What it is

Tecentriq is atezolizumab, supplied as a concentrated injection for intravenous infusion. Two intravenous formulations are available: 840 mg in 14 mL and 1200 mg in 20 mL, both at a concentration of 60 mg/mL. The initial dose must be administered over 60 minutes, and if tolerated, all subsequent infusions may be administered over 30 minutes.

Approved indications

— Adjuvant treatment following complete resection and no progression after platinum-based adjuvant chemotherapy for adult patients with stage II to IIIA NSCLC whose tumours have PD-L1 expression on ≥ 50% of tumour cells. — First-line treatment of adult patients with metastatic non-squamous NSCLC in combination with bevacizumab, paclitaxel and carboplatin. — First-line treatment of patients with metastatic non-squamous NSCLC who do not have tumour EGFR or ALK genomic aberrations in combination with nanoparticle albumin-bound paclitaxel and carboplatin. — Treatment of adult patients with locally advanced or metastatic NSCLC after prior chemotherapy as monotherapy. — First-line treatment of patients with extensive-stage small cell lung cancer in combination with carboplatin and etoposide. — Treatment of patients with locally advanced or metastatic urothelial carcinoma who are considered cisplatin ineligible and whose tumours express PD-L1 on tumour-infiltrating immune cells covering ≥ 5% of the tumour area. — Treatment of patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy in combination with bevacizumab.

Dosing overview

Tecentriq must be initiated and supervised by physicians experienced in the treatment of cancer. Atezolizumab was originally developed using an every-three-weeks monotherapy dosing regimen, with subsequent approval of every-two-weeks and every-four-weeks dosing regimens based on pharmacokinetic and exposure-response modelling and simulations.

Key safety warnings

For urothelial carcinoma, this indication is approved based on overall response rate and duration of response in a single-arm study. Improvements in overall survival, progression-free survival, or health-related quality of life have not been established.

Contraindications

No contraindications are specified in the provided documents.

PBS listing

The 1200 mg in 20 mL intravenous solution concentrate is listed on the PBS with 18 items, streamlined restriction, at an ex-manufacturer price of A$6747.37. The 840 mg in 14 mL intravenous solution concentrate is listed on the PBS with 12 items, streamlined restriction, at an ex-manufacturer price of A$4723.15.

Regulatory history

Tecentriq 1200 mg in 20 mL was first listed on the ARTG on 27 July 2017, and the 840 mg in 14 mL formulation was first listed on 31 July 2019. In November 2014, the PBAC recommended Tecentriq for the treatment of locally advanced or metastatic NSCLC in patients who had progressed on or after platinum-containing chemotherapy. In November 2019, the PBAC recommended Tecentriq for first-line treatment of extensive-stage SCLC in combination with platinum-based chemotherapy and etoposide. In July 2022, the PBAC recommended Tecentriq for adjuvant treatment in patients with PD-L1 positive Stage II-IIIA NSCLC following complete resection and platinum-based chemotherapy.