{"id":46815,"date":"2022-08-02T07:01:55","date_gmt":"2022-08-02T05:01:55","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/genentechs-subcutaneous-formulation-of-tecentriq-demonstrates-positive-phase-iii-results\/"},"modified":"2022-08-02T07:01:55","modified_gmt":"2022-08-02T05:01:55","slug":"genentechs-subcutaneous-formulation-of-tecentriq-demonstrates-positive-phase-iii-results","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/genentechs-subcutaneous-formulation-of-tecentriq-demonstrates-positive-phase-iii-results\/","title":{"rendered":"Genentech\u2019s Subcutaneous Formulation of Tecentriq Demonstrates Positive Phase III Results"},"content":{"rendered":"
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\n\u2013 IMscin001 study showed non-inferior levels of cancer immunotherapy Tecentriq in the blood, when injected subcutaneously, compared to intravenous infusion, in people with advanced non-small cell lung cancer \u2013<\/i>\n<\/p>\n

\n\u2013 Administered under the skin, the subcutaneous formulation reduces time spent receiving treatment to just minutes, compared with up to an hour for IV infusion \u2013<\/i>\n<\/p>\n

\n\u2013 Data will be submitted to health authorities globally, including the U.S. Food and Drug Administration and European Medicines Agency \u2013<\/i>\n<\/p>\n

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), <\/b>today announced that the Phase III IMscin001 study evaluating a subcutaneous formulation of Tecentriq\u00ae<\/sup> (atezolizumab) met its co-primary endpoints. The study showed non-inferior levels of Tecentriq in the blood (pharmacokinetics), when injected subcutaneously, compared with intravenous (IV) infusion, in cancer immunotherapy-na\u00efve patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) for whom prior platinum therapy has failed. The safety profile of the subcutaneous formulation was consistent with that of IV Tecentriq.\n<\/p>\n

<\/a><\/p>\n

\nAdministering Tecentriq subcutaneously (injecting the medicine under the skin) reduces the treatment time to 3-8 minutes per injection, compared with 30-60 minutes for standard IV infusion.\n<\/p>\n

\n\u201cBy reducing the administration time, this new Tecentriq formulation could help save time for patients and healthcare systems,\u201d said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. \u201cWe 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.\u201d\n<\/p>\n

\nMultiple oncology studies suggest that the majority of cancer patients generally prefer to receive treatment subcutaneously due to reduced pain and discomfort, ease of administration and shorter duration of treatment, compared to IV infusion.\n<\/p>\n

\nGenentech will share detailed findings of the IMscin001 study at an upcoming medical meeting and submit them for regulatory approval to health authorities globally, including the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA).\n<\/p>\n

\nAbout the IMscin001 study<\/b>\n<\/p>\n

\nIMscin001 is a Phase Ib\/III, global, multicenter, randomized study evaluating the pharmacokinetics, safety and efficacy of the subcutaneous formulation of Tecentriq, compared with IV Tecentriq, in patients with previously treated locally advanced or metastatic NSCLC for whom prior platinum therapy has failed. The study enrolled 371 patients. The co-primary endpoints of the study are minimum levels of Tecentriq in the blood during a given dosing interval on the basis of established pharmacokinetic measurements; observed serum Ctrough<\/sub> and model-predicted area under the curve. Secondary endpoints include safety, immunogenicity, patient-reported outcomes and efficacy.\n<\/p>\n

\nAbout lung cancer<\/b>\n<\/p>\n

\nAccording to the American Cancer Society, it is estimated that more than 235,000 Americans will be diagnosed with lung cancer in 2022. NSCLC accounts for 80-85% of all lung cancers. Cancer immunotherapy alone or in combination with platinum-containing chemotherapy is a standard of care treatment in first- and second-line NSCLC. However, people who progress after this initial therapy have limited treatment options and survival outcomes remain poor. Developing treatment regimens for people with metastatic disease, who experience disease progression after initial treatment, is critical to extending the survival of patients.\n<\/p>\n

\nAbout the subcutaneous formulation of Tecentriq<\/b>\n<\/p>\n

\nThe investigational subcutaneous formulation combines Tecentriq with Halozyme Therapeutics\u2019 Enhanze\u00ae<\/sup> drug delivery technology.\n<\/p>\n

\nTecentriq is a monoclonal antibody designed to bind with a protein called programmed death ligand-1 (PD-L1), which is expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T-cells. Tecentriq is a cancer immunotherapy that has the potential to be used as a foundational combination partner with other immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers.\n<\/p>\n

\nThe Enhanze drug delivery technology is based on a proprietary recombinant human hyaluronidase PH20 (rHuPH20), an enzyme that locally and temporarily degrades hyaluronan \u2013 a glycosaminoglycan or chain of natural sugars in the body \u2013 in the subcutaneous space. This increases the permeability of the tissue under the skin, allowing space for Tecentriq to enter, and enables the subcutaneous formulation to be rapidly dispersed and absorbed into the bloodstream.\n<\/p>\n

\nIV Tecentriq is approved for some of the most aggressive and difficult-to-treat forms of cancer. IV Tecentriq was the first cancer immunotherapy approved for the treatment of a certain type of early-stage NSCLC, small cell lung cancer (SCLC) and hepatocellular carcinoma (HCC). IV Tecentriq is also approved either alone or in combination with targeted therapies and\/or chemotherapies for various forms of metastatic NSCLC, certain types of metastatic urothelial cancer and BRAF V600 mutation-positive advanced melanoma.\n<\/p>\n

\nAbout Tecentriq\u00ae<\/sup> (atezolizumab)<\/b>\n<\/p>\n

\nTecentriq is a monoclonal antibody designed to bind with a protein called PD-L1. Tecentriq is designed to bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells.\n<\/p>\n

\nTecentriq U.S. Indications<\/b>\n<\/p>\n

\nTecentriq is a prescription medicine used to treat adults with:\n<\/p>\n

\nA type of bladder and urinary tract cancer called urothelial carcinoma.<\/b>\n<\/p>\n

\nTecentriq may be used in patients with urothelial carcinoma if their bladder cancer has spread or cannot be removed by surgery, and if they have any one of the following conditions:<\/b>\n<\/p>\n