Roche has reported that its Phase III IMscin001 clinical trial of cancer immunotherapy, subcutaneous dose of Tecentriq (atezolizumab), in advanced non-small cell lung cancer (NSCLC) patients met its co-primary endpoints.
An international, multicentre, randomised Phase Ib/III trial, IMscin001 is designed to analyse the safety, efficacy and pharmacokinetics of subcutaneous Tecentriq versus intravenous (IV) Tecentriq.
It enrolled 371 priorly treated locally advanced or metastatic NSCLC patients who did not respond to previous platinum therapy.
The least Tecentriq levels in the blood during a particular dosing interval based on validated pharmacokinetic measurements, reported serum Ctrough and model-predicted area under the curve (AUC) were the trial’s co-primary endpoints.
Safety, subject-reported outcomes, immunogenicity and efficacy were the trial’s secondary endpoints.
According to the positive data from the trial, non-inferior levels of Tecentriq in the blood (pharmacokinetics) were reported on administering subcutaneous dose versus IV infusion in these cancer immunotherapy-naïve trial subjects.
Furthermore, the subcutaneous formulation’s safety profile was in line with that of IV Tecentriq.
Compared to 30-60 minutes for conventional IV infusion, subcutaneous Tecentriq lowers the therapy duration to three-eight minutes for each injection.
The company plans to submit these data to health agencies across the globe, including the US Food and Drug Administration and European Medicines Agency.
A monoclonal antibody, Tecentriq attaches with programmed death ligand-1 (PD-L1) protein.
This investigational subcutaneous formulation merges Tecentriq with the Enhanze drug delivery technology of Halozyme Therapeutics.
Roche Global Product Development head and chief medical officer Levi Garraway said: “By reducing the administration time, this new Tecentriq formulation could help save time for patients and healthcare systems.
“We are excited by the potential of bringing a subcutaneous cancer immunotherapy to patients globally, delivering on our commitment to improve the treatment experience for patients.”