FDA Approves Subcutaneous Formulation of Atezolizumab for Patients With Certain Solid Tumors
On September 12th, 2024, the US Food and Drug Administration (FDA) approved a subcutaneous coformulation of atezolizumab plus hyaluronidase for adult patients with non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), hepatocellular carcinoma, melanoma, and alveolar soft part sarcoma. This approval was based on results from the IMscin001 trial.
This multicenter, open-label trial enrolled 371 patients with locally advanced or metastatic NSCLC who had undergone immunotherapy and experienced disease progression with platinum-based chemotherapy. Patients were randomized on a 2-to-1 basis to receive either 1875 mg of subcutaneous atezolizumab plus hyaluronidase (30 000 units) or intravenous atezolizumab once every 3 weeks until disease progression or unacceptable toxicity. Co-primary end points included atezolizumab exposure and pharmacokinetic end points of cycle 1 trough concentration (Ctrough) and AUC0-21days. Secondary efficacy end points included overall response rate (ORR), progression-free survival (PFS), overall survival (OS), and safety.
At analysis, the geometric mean ratio of subcutaneous atezolizumab and intravenous atezolizumab for cycle Ctrough was 1.05 and AUC0-21 was 0.87. No notable differences in ORR, PFS, or OS were observed between the 2 arms. The confirmed ORR was 9% in the subcutaneous arm and 8% in the intravenous arm. The most common adverse reactions occurring in ≥10% of patients included fatigue, musculoskeletal pain, cough, dyspnea, and decreased appetite.
The recommended dose of the subcutaneous atezolizumab formulation is 1875 mg of atezolizumab plus 30,000 units of hyaluronidase administered in the thigh for approximately 7 minutes once every 3 weeks.
Source:
FDA approves atezolizumab and hyaluronidase-tqjs for subcutaneous injection. Accessed September 13, 2024.https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-atezolizumab-and-hyaluronidase-tqjs-subcutaneous-injection
