Zachary Bessette

DocwireNews

The United States Food and Drug Administration (FDA) has <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-atezolizumab-and-hyaluronidase-tqjs-subcutaneous-injection" target="_blank" rel="noopener">granted approval</a> for atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Genentech) for subcutaneous injection in adult patients with hepatocellular carcinoma (HCC).
The atezolizumab and hyaluronidase-tqjs subcutaneous combination was also approved for non-small cell lung cancer, small cell lung cancer, melanoma, and alveolar soft part sarcoma.
FDA approval comes after the results of the IMscin001 trial, an open-label, multi-center, international analysis of adult patients who were not previously treated with immunotherapy and who had not experienced disease progression following treatment with platinum-based chemotherapy. In the trial, a total of 371 patients were randomized (2:1) to receive subcutaneous atezolizumab and hyaluronidase-tqjs or intravenous atezolizumab until disease progression or unacceptable toxicity.
The primary outcome measure of IMscin001 was atezolizumab exposure. The co-primary pharmacokinetic endpoints were Cycle 1 Ctrough and AUC0-21days. Additional efficacy outcome measures included overall response rate (ORR), progression-free survival (PFS), and overall survival (OS).
The geometric mean ratio (90% CI) of subcutaneous atezolizumab and intravenous atezolizumab for Cycle 1 Ctrough was 1.05 and 0.87 for AUC0-21days. These met the lower limit of the geometric mean ratio (90% CI) above the pre-specified threshold of 0.80 for comparability.
No notable differences were reported between the different formulations with regard to ORR, PFS, or OS; the confirmed ORR was 9% in the subcutaneous atezolizumab and hyaluronidase-tqjs arm and 8% in the intravenous atezolizumab arm.
Common adverse events of any grade included fatigue, musculoskeletal pain, cough, dyspnea, and decreased appetite.
The FDA noted that the recommended dosage is a single subcutaneous injection (15 mL containing 1,875 mg of atezolizumab and 30,000 units of hyaluronidase) administered in the thigh over a 7-minute span every 3 weeks.

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FDA approval comes after the IMscin001 trial, an open-label, multi-center, international analysis of adult patients.

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