The US Food and Drug Administration (FDA) has approved it atezolizumab and hyaluronidase-tqjs（ Product Name Tecentriq Hybreza） Subcutaneous injection type, suitable for all original intravenous injection types atezolizumab（Tecentriq） Adult indications include:
Non small cell lung cancer (NSCLC)
Small cell lung cancer (SCLC)
Hepatocellular carcinoma (HCC)
Melanoma
Alveolar soft tissue sarcoma
Efficacy and Safety
The evaluation of the subcutaneous injection formulation was based on the IMscin001 clinical trial (ClinicalTrials.gov ID NCT03735121). This was an open-label, multicenter, international randomized study in adult patients with locally advanced or metastatic NSCLC who had progressed after platinum-based chemotherapy and had not received prior cancer immunotherapy. A total of 371 patients were randomized 2:1 to receive either subcutaneous atezolizumab/hyaluronidase-tqjs or intravenous atezolizumab until disease progression or intolerable toxicity. The primary endpoint was atezolizumab exposure. Key pharmacokinetic (PK) endpoints included: Cycle 1 Ctrough (end-of-cycle trough concentration); AUC 0–21 days (area under the curve over 21 days). The geometric mean ratio (GMR, 90% CI) for subcutaneous versus intravenous formulations was as follows: Cycle 1 Ctrough: 1.05 (0.88–1.24); AUC 0–21 days: 0.87 (0.83–0.92). The data showed that the lower limit of GMR for the subcutaneous formulation (0.8) met the pre-specified comparability criteria. No significant differences were observed between the two groups in objective response rate (ORR), progression-free survival (PFS), or overall survival (OS):
Confirmed ORR in the subcutaneous group was 9% (95% CI = 5%–13%)
Confirmed ORR in the intravenous group was 8% (95% CI = 4%–14%)
The most common adverse reactions (any grade, incidence ≥10%) included: fatigue, musculoskeletal pain, cough, dyspnea, and decreased appetite.
Recommended Dosage: Administer 15 ml (containing 1,875 mg atezolizumab and 30,000 units of hyaluronidase) subcutaneously in the thigh every 3 weeks, over approximately 7 minutes. Full prescribing information for Tecentriq Hybreza will be available at Drugs@FDA. This approval is effective September 12, 2024.
Disclaimer: This article has not been reviewed by the American Society of Clinical Oncology (ASCO®) and does not represent the views or positions of ASCO®.
Source: https://ascopost.com/news/september-2024/fda-approves-atezolizumab-and-hyaluronidase-tqjs-for-subcutaneous-injection/