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Cancer Immunotherapy Phase III Trial Yields Positive Results
On August 1, Roche announced that their Phase III study of Tecentriq® (atezolizumab) met its primary endpoints. The cancer immunotherapy showed non-inferior levels when injected subcutaneously as opposed to an intravenous infusion. Roche will forward the data gathered from this study to global health authorities such as the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA).
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What is Tecentriq and its delivery method?
Tecentriq is an antibody that binds with a protein called programmed death ligand-1 (PD-L1). Numerous tumor cells and tumor-infiltrating immune cells express this protein. By binding to PD-L1, Tecentriq prevents the protein from interacting with its receptors. As a result, Tecentriq enables T-Cell activation.
For some time, intravenous (IV) infusion was the approved method for delivering this cancer immunotherapy. IV infusions of Tecentriq are used to combat various aggressive forms of cancer, such as small cell lung cancer (SCLC) and hepatocellular carcinoma (HCC).
However, the method tested by the Phase III study used Halozyme Therapeutics’ Enhanze® drug delivery technology. This method used an enzyme known as recombinant human hyaluronidase PH20 (rHuPH20) to dissolve a chain of natural sugars located beneath the skin. Injected into the enzyme this way, the cancer immunotherapy disperses and absorbs into the bloodstream more swiftly.
Results of the IMscin001 study
IMscin001 is a Phase Ib/III, global, multicentre, randomized study evaluating the effectiveness and safety of Tecentriq when injected subcutaneously as opposed to an intravenous infusion. The subjects of the study were patients with previously treated locally advanced or metastatic NSCLC for whom prior platinum therapy has failed.
The results showed that subcutaneously Tecentriq was just as present in patients’ blood as IV Tecentriq. The safety profile of the subcutaneous treatment matched closely and consistently with its IV counterpart. In addition, treatment time reduced drastically. The study found that subcutaneous Tecentriq only took 3-8 minutes per injection. This is vastly shorter to an IV infusion’s standard 30-60 minute injection time.
Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development, 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.”
Roche intends to share the findings of the IMscin001 study at an upcoming medical meeting. The company will then submit the results for regulatory approval to global health organizations such as the FDA and EMA.
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