THE PHARMACOKINETICS, EFFICACY, IMMUNOGENICITY, AND SAFETY OF ATEZOLIZUMAB SUBCUTANEOUS IN NON-SMALL-CELL LUNG CANCER. IMSCIN001 CLINICAL STUDY (PART 2)

Abstract

The programmed cell death-ligand 1 (PD-L1) inhibitor atezolizumab is approved for IV use in various solid tumour types. To improve treatment convenience and healthcare efficiencies, a coformulation of atezolizumab and recombinant human hyaluronidase PH20 was developed for subcutaneous use. Part 2 of IMscin001 was a randomised phase III, open-label, multicentre noninferiority study, which confirmed that subcutaneous atezolizumab, compared with intravenous form, demonstrated noninferior drug exposure at cycle 1. Efficacy, safety, and immunogenicity were similar between arms and consistent with the known profile for intravenous atezolizumab. Similar drug exposure and clinical outcomes following subcutaneous and intravenous atezolizumad administration support the use of subcutaneous atezolizumab as an alternative to atezolizumab intravenous, which has the potential to improve efficiencies in healthcare and increase convenience for both patients and healthcare professionals.