The U.S. Food and Drug Administration (FDA) approved atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza) for subcutaneous injection for all the adult indications as the intravenous formulation of atezolizumab (Tecentriq), including non–small cell lung cancer (NSCLC), small cell lung cancer (SCLC), hepatocellular carcinoma (HCC), melanoma, and alveolar soft-part sarcoma.
Efficacy and Safety
The subcutaneous injection of atezolizumab and hyaluronidase-tqjs was evaluated in IMscin001 (ClinicalTrials.gov identifier NCT03735121), an open-label, multicenter, international, randomized trial in adults with locally advanced or metastatic NSCLC who were not previously exposed to cancer immunotherapy and who had disease progression after treatment with platinum-based chemotherapy. A total of 371 patients were randomly assigned 2:1 to receive subcutaneous atezolizumab and hyaluronidase-tqjs or intravenous atezolizumab until disease progression or unacceptable toxicity.
The primary outcome measure was atezolizumab exposure, with coprimary pharmacokinetic (PK) endpoints of cycle 1Ctrough and area under the curve (AUC)0–21days. Additional descriptive efficacy outcome measures were overall response rate, progression-free survival, and overall survival. The geometric mean ratio (90% confidence interval [CI]) of subcutaneous atezolizumab and intravenous atezolizumab for cycle 1Ctrough was 1.05 (0.88–1.24) and AUC0–21days was 0.87 (0.83–0.92), which met the lower limit of the geometric mean ratio (90% CI) above the prespecified threshold of 0.8 for comparability. No notable differences in overall response rate, progression-free survival. or overall survival were observed between the different formulations. The confirmed overall response rate was 9% (95% CI = 5%–13%) with subcutaneous atezolizumab and hyaluronidase-tqjs and 8% (95% CI = 4%–14%) with intravenous atezolizumab.
The most common adverse reactions of any grade (≥ 10%) were fatigue, musculoskeletal pain, cough, dyspnea, and decreased appetite.
The recommended dosage is one 15 mL injection (containing 1,875 mg of atezolizumab and 30,000 units of hyaluronidase) administered subcutaneously in the thigh over approximately 7 minutes every 3 weeks.
Full prescribing information for Tecentriq Hybreza will be posted on Drugs@FDA. The approval was made on September 12, 2024.
