On 12 September 2024, the US Food and Drug Administration (FDA) approved atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Genentech, Inc.) for subcutaneous injection for all the adult indications as the intravenous formulation of atezolizumab (Tecentriq, Genentech, Inc.), including non-small cell lung cancer (NSCLC), small cell lung cancer, hepatocellular carcinoma, melanoma, and alveolar soft part sarcoma.<\/p>\n
The subcutaneous injection of atezolizumab and hyaluronidase-tqjs was evaluated in IMscin001 (NCT03735121), an open-label, multicentre, international, randomised study in adult patients with locally advanced or metastatic NSCLC who were not previously exposed to cancer immunotherapy and who had disease progression following treatment with platinum-based chemotherapy. A total of 371 patients were randomised (2:1) to receive subcutaneous atezolizumab and hyaluronidase-tqjs or intravenous atezolizumab until disease progression or unacceptable toxicity.<\/p>\n
The primary outcome measure was atezolizumab exposure, with coprimary pharmacokinetic endpoints of Cycle 1 Ctrough <\/sub>and AUC0-21days<\/sub>. Additional descriptive efficacy outcome measures were overall response rate (ORR), progression-free survival (PFS), and overall survival (OS).<\/p>\n The geometric mean ratio (GMR) (90% confidence interval [CI]) of subcutaneous atezolizumab and intravenous atezolizumab for Cycle 1 Ctrough <\/sub>was 1.05 (0.88, 1.24) and AUC0-21days <\/sub>was 0.87 (0.83, 0.92), which met the lower limit of the GMR (90% CI) above the pre-specified threshold of 0.8 for comparability.<\/p>\n No notable differences in ORR, PFS or OS were observed between the different formulations. The confirmed ORR was 9% (95% CI 5, 13) in the subcutaneous atezolizumab and hyaluronidase-tqjs arm and 8% (95% CI: 4, 14) in the intravenous atezolizumab arm.<\/p>\n The most common adverse reactions of any grade (\u2265 10%) were fatigue, musculoskeletal pain, cough, dyspnoea, and decreased appetite.<\/p>\n 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.<\/p>\n This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA\u2019s assessment.<\/p>\n Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA\u2019s MedWatch Reporting System.<\/p>\n For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact FDA\u2019s Oncology Center of Excellence<\/a> Project Facilitate<\/a>.<\/p>\n