The U.S. Food and Drug Administration (FDA) has approved atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza) for subcutaneous injection, offering a faster alternative to intravenous atezolizumab (Tecentriq) for all approved adult indications. This new formulation combines atezolizumab, an immune checkpoint inhibitor, with hyaluronidase-tqjs, an enzyme that facilitates subcutaneous dispersion.
Clinical Trial Data
The approval was primarily based on the results of the Phase III IMscin001 clinical trial. This open-label, multicenter, international, randomized study involved 371 patients with locally advanced or metastatic non-small cell lung cancer who had progressed following platinum-based chemotherapy and had not previously been treated with cancer immunotherapy. Patients were randomized in a 2:1 ratio to receive either subcutaneous atezolizumab and hyaluronidase-tqjs or intravenous atezolizumab.
Data from the IMscin001 trial indicated comparable drug exposure between the two formulations. After a single dose, the average serum atezolizumab concentration was 89 µg/mL in the subcutaneous arm and 85 µg/mL in the intravenous arm. Response rates were also similar, with 9% in the subcutaneous arm and 8% in the intravenous arm.
Dosing and Administration
The recommended dose for the subcutaneous formulation is 1,875 mg of atezolizumab plus 30,000 units of hyaluronidase in a 15 mL injection, administered every three weeks. A significant advantage of the subcutaneous injection is the reduced administration time, approximately seven minutes, compared to the 30 to 60 minutes required for intravenous infusion.
Patient Preference
Preliminary results from the IMscin002 trial, a follow-up study to IMscin001, demonstrated that 70.7% of patients preferred the subcutaneous formulation of atezolizumab and hyaluronidase-tqjs over the intravenous formulation.
Approved Indications
Atezolizumab and hyaluronidase can now be used for all approved adult indications of intravenous atezolizumab, including certain lung cancers, melanomas, soft tissue sarcomas, and liver cancers. Atezolizumab functions as an immune checkpoint inhibitor, enhancing the immune system's ability to fight cancer cells by blocking natural inhibitory pathways.
