Originally published by our sister publication Clinical Oncology News
By Clinical Oncology News Staff
The FDA has approved atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Genentech) for subcutaneous injection for all the adult indications as the intravenous formulation of atezolizumab (Tecentriq, Genentech), including non-small cell lung cancer (NSCLC), small cell lung cancer, hepatocellular carcinoma, melanoma and alveolar soft part sarcoma.
The subcutaneous injection of atezolizumab and hyaluronidase-tqjs was evaluated in IMscin001 (ClinicalTrials.gov. Identifier: NCT03735121), an open-label, multicenter, international, randomized trial 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 randomized (2:1) to receive subcutaneous atezolizumab and hyaluronidase-tqjs or IV atezolizumab until disease progression or unacceptable toxicity.
The primary outcome measure was atezolizumab exposure, with co-primary pharmacokinetic end points of cycle 1 Ctrough and AUC0-21days. Additional descriptive efficacy outcome measures were overall response rate (ORR), progression-free survival (PFS) and overall survival (OS). The geometric mean ratio (GMR) (90% CI) of subcutaneous atezolizumab and IV atezolizumab for cycle 1 Ctrough was 1.05 (0.88-1.24) and AUC0-21days 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. 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 IV atezolizumab arm.
The most common adverse reactions of any grade (≥10%) were fatigue, musculoskeletal pain, cough, dyspnea and decreased appetite.
Full prescribing information for Tecentriq Hybreza is posted here.
Based on a press release from the FDA.