Genentech’s Subcutaneous Tecentriq Demonstrates Positive Phase 3 Results for NSCLC
IMscin001 analysis shows non-inferior levels of the cancer immunotherapy in the blood compared with intravenous infusion in individuals with advanced non–small cell lung cancer.
Genentech announced that the phase 3 IMscin001 study evaluating a subcutaneous formulation of atezolizumab (Tecentriq) met its co-primary endpoints in individuals with locally advanced or metastatic non–small cell lung cancer (NSCLC) who are immunotherapy-naïve and when platinum therapy was not successful.
The results showed non-inferior levels of atezolizumab in the blood when injected subcutaneously compared with intravenous (IV) infusion, according to a company statement.
The safety profile of the subcutaneous formulation was consistent with that of the IV formulation.
“By reducing the administration time, this new [atezolizumab] formulation could help save time for patients and health care systems,” Levi Garraway, MD, PhD, CEO and head of global product development of Genentech, said in a statement. “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.”
The administration of atezolizumab subcutaneously reduced the treatment time to about 3 to 8 minutes per injection compared with 30 minutes to 1 hour for the standard IV infusion.
Multiple studies concluded that the majority of individuals with cancer generally prefer to receive treatment subcutaneously because of ease of administration, reduced discomfort and pain, and shorter duration of treatment compared with IV infusions, according to the company statement.
Genentech will share detailed findings of the study at an upcoming medical meeting and submit them for regulatory approval to health agencies worldwide, including the European Medicines Agency and the FDA.
IMscin001 is a global, multicenter, phase 1b/3, randomized study evaluating the efficacy, pharmacokinetics, and safety of the subcutaneous formulation of atezolizumab compared with atezolizumab in the IV formulation in individuals with locally advanced or metastatic NSCLC and when prior platinum therapy was not successful.
Investigators included 371 individuals in the study with the co-primary endpoints being minimum levels of atezolizumab in the blood during a given dosing interval on the basis of established pharmacokinetic measures, as well as observed serum Ctrough and model-predicted area under the curve.
Secondary endpoints of the study included efficacy, immunogenicity, patient-reported outcomes, and safety.
The most common adverse events (AEs) of atezolizumab, when used alone, include cough, decreased appetite, fatigue, nausea, shortness of breath, and weakness. When atezolizumab is used to treat lung cancer, the AEs also include constipation, diarrhea, and hair loss.
Atezolizumab is a monoclonal antibody that is designed to bind with PD-L1 proteins, which are expressed in tumor cells and tumor-infiltrating immune cells, blocking its interaction with both B7.1 and PD-1 receptors, according to the company statement.
It is indicated for individuals with urothelial carcinoma and NSCLC, as a monotherapy, first-line treatment, with other medications, such as bevacizumab, carboplatin, and paclitaxel, in the first line, and with paclitaxel protein-bound and carboplatin, in the first line.
It has also been indicated for hepatocellular carcinoma, melanoma, and small-cell lung cancer.
It is unclear if atezolizumab is effective and safe for children.
Genentech’s subcutaneous formulation of Tecentriq demonstrates positive phase 3 results. News release. Genentech. August 1, 2022. Accessed August 2, 2022. https://www.gene.com/media/press-releases/14963/2022-08-01/genentechs-subcutaneous-formulation-of-t