Subcutaneous administration of atezolizumab and hyaluronidase-tqjs had similar efficacy to intravenous administration.
The FDA approved atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Genetech, Inc) for subcutaneous injection for all adult indications approved for the intravenous formulation of atezolizumab (Tecentriq, Genetech, Inc). These include non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), melanoma, and hepatocellular carcinoma (HCC).1,2
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This approval was based on the positive results from the phase 1B/3 IMscin001 study. In the trial, patients who were administered atezolizumab and hyaluronidase-tqjs subcutaneously showed comparable levels of the drug in the blood, along with similar safety and efficacy profiles, to intravenous administration.3,4
“By enabling subcutaneous administration for a cancer immunotherapy, [atezolizumab and hyaluronidase-tqjs] Tecentriq Hybreza now offers patients with multiple cancer types and their physicians greater flexibility and choice of treatment administration,” Levi Garraway, MD, PhD, chief medical officer at Roche said in a news release by the company.2
IMscin001 met both of its co-primary end points. Firstly, the geometric mean ratio of subcutaneous atezolizumab and intravenous atezolizumab for cycle 1 Ctrough was 1.05 and area under the curve0-21 days was 0.87, meeting the lower limit of the GMR above the pre-specified threshold of 0.8 for comparability.1,3
Continuing, there were no significant differences in overall response rate (ORR), progression-free survival, or overall survival observed between the different formulations. In the subcutaneous atezolizumab and hyaluronidase-tqjs arm, ORR was 9% (95% CI: 5, 13) while in the intravenous atezolizumab ORR was 8% (95% CI: 4, 14).1,3
FDA, in their news release, recommended a dosage of one 15 mL injection, containing 1875 mg of atezolizumab and 30,000 units of hyaluronidase, administered subcutaneously in the thigh over around 7 minutes in 3-week intervals. The 7-minute administration duration compares with 30-60 minutes for intravenous infusion, highlighting the speed and effectiveness of this new formulation.1,2
Phase 2 of the IMscin002 study demonstrated that 71% of patients in the trial preferred subcutaneous atezolizumab and hyaluronidase-tqjs over intravenous administration of atezolizumab. The most common reasons provided by respondents were increased comfort during treatment, reduced emotional stress, and having to spend less time in the clinic. Importantly, after utilizing both formulations, 79% of patients in the study chose atezolizumab and hyaluronidase-tqjs.2
Trial Name: A Study to Investigate Atezolizumab Subcutaneous in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT03735121
Sponsor: Hoffmann-La Roche
Estimated Completion: December 31, 2024
Ann Fish-Steagall, RN, said in the news release that the approval “represents a significant option to improve the patient experience” of cancer treatment. “When patients have options, they feel empowered to be vital participants in their own care and choose their preferred treatment option."2
Because the active ingredient in both the subcutaneous and intravenous formulations are the same, the investigators expected that each type of the drug would yield a “comparable degree of target-site saturation, resulting in similar efficacy. This expectation was supposed by the positive early safety and efficacy data released.3
Atezolizumab is a monoclonal antibody that is designed to bind with PD-(L)1 proteins. By binding to these proteins on tumor cells and tumor-infiltrating immune cells, it blocks interactions with PD-1 and B7.1 receptors, thereby enabling the reactivation of T cells. Prior to this approval, atezolizumab was approved as a subcutaneous formulation in 50 countries outside the United States.2
