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.
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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.
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By GlobalDataFurthermore, 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.”
