The U.S. Food and Drug Administration (FDA) has approved atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Genentech, Inc.) for subcutaneous injection. This formulation is approved for the same adult indications as the intravenous version of atezolizumab (Tecentriq, Genentech, Inc.), including non–small cell lung cancer (NSCLC), small cell lung cancer, hepatocellular carcinoma, melanoma, and alveolar soft part sarcoma.
The efficacy and safety of the subcutaneous injection were assessed in the IMscin001 study (ClinicalTrials.gov identifier NCT03735121), an open-label, multicenter, international, randomized trial. The trial included 371 adult patients with locally advanced or metastatic NSCLC who had not received prior cancer immunotherapy and had disease progression following platinum-based chemotherapy. Participants were randomized in a 2:1 ratio to receive either subcutaneous atezolizumab and hyaluronidase-tqjs or intravenous atezolizumab until disease progression or unacceptable toxicity.
Primary outcome measures included atezolizumab exposure, with pharmacokinetic endpoints of Cycle 1 Ctrough and AUC0-21 days. The geometric mean ratio for the subcutaneous versus intravenous formulations was 1.05 (90% confidence interval [CI] = 0.88–1.24) for Cycle 1 Ctrough and 0.87 (90% CI = 0.83–0.92) for AUC0-21 days ,meeting the predefined comparability threshold. No significant differences were observed between formulations in terms of overall response rate (ORR), progression-free survival, or overall survival. The ORR was 9% (95% CI = 5%–13%) for the subcutaneous group and 8% (95% CI = 4%–14%) for the intravenous group.
Common adverse reactions (≥ 10%) among patients receiving the subcutaneous injection formulation included fatigue, musculoskeletal pain, cough, dyspnea, and decreased appetite. The recommended dosage is one 15 mL injection administered subcutaneously every 3 weeks.
Citation:
U.S. Food and Drug Administration. FDA approves atezolizumab and hyaluronidase-tqjs for subcutaneous injection. Published September 12, 2024. Accessed [September 13, 2024]. Available from: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-atezolizumab-and-hyaluronidase-tqjs-subcutaneous-injection.