FDA Approves Subcutaneous Tecentriq Hybreza for Multiple Cancer Types
核心洞察
The FDA has approved Tecentriq Hybreza, a subcutaneous formulation of atezolizumab, for various cancer indications, offering a new administration route.
Approval was based on the IMscin001 trial, which demonstrated comparable atezolizumab exposure between subcutaneous and intravenous administrations.
Tecentriq Hybreza combines atezolizumab with hyaluronidase to enhance subcutaneous tissue permeability, facilitating drug delivery.
The U.S. Food and Drug Administration (FDA) has approved Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) for subcutaneous (SC) injection, providing a new administration option for patients across several cancer types. This approval covers all indications previously approved for intravenous atezolizumab, including non-small cell lung cancer (搜索) (NSCLC), small cell lung cancer (搜索), hepatocellular carcinoma (搜索), melanoma (搜索), and alveolar soft part sarcoma (搜索).
Tecentriq Hybreza combines atezolizumab, a PD-L1 (搜索) blocking antibody, with hyaluronidase, an endoglycosidase that increases the permeability of subcutaneous tissue. This combination allows for subcutaneous administration, offering a potentially faster and more convenient alternative to intravenous infusions.
IMscin001 Trial Results
The approval was primarily based on data from the IMscin001 trial (NCT03735121), an open-label, randomized study involving adults with locally advanced or metastatic NSCLC who had not previously received immunotherapy and had experienced disease progression following platinum-based chemotherapy. Patients were randomized to receive either Tecentriq Hybreza SC (n=247) or intravenous atezolizumab (n=124) every three weeks until disease progression or unacceptable toxicity. The primary endpoint of the trial was atezolizumab exposure.
Results from the IMscin001 trial demonstrated comparable atezolizumab exposure between the Tecentriq Hybreza and intravenous atezolizumab groups. The confirmed overall response rate (ORR) was 9% in the Tecentriq Hybreza arm and 8% in the intravenous atezolizumab arm, indicating similar efficacy between the two administration routes. Furthermore, no significant differences were observed in progression-free survival (PFS) or overall survival (OS) between the groups.
The most common adverse reactions reported with Tecentriq Hybreza were fatigue, musculoskeletal pain, cough, dyspnea, and decreased appetite. These adverse reactions are consistent with those observed with intravenous atezolizumab.
Dosage and Administration
Tecentriq Hybreza is supplied in a single-dose vial containing 1875 mg of atezolizumab and 30,000 units of hyaluronidase per 15 mL. It is administered subcutaneously into the thigh over approximately 7 minutes, offering a significantly shorter administration time compared to intravenous infusions.