FDA approves first subcutaneous anti-PD-L1 cancer immunotherapy
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The FDA approved atezolizumab and hyaluronidase-tqjs for subcutaneous injection.
The agent (Tecentriq Hybreza, Genentech) is the first subcutaneous anti-PD-L1 cancer immunotherapy approved in the United States.
It is approved for all of the same adult indications for which atezolizumab (Tecentriq, Genentech) — a monoclonal antibody that binds to PD-L1 — already is approved. These include treatment of certain patients with small cell lung cancer, non-small cell lung cancer, melanoma, hepatocellular carcinoma and alveolar soft part sarcoma.
Treatment with the subcutaneous formulation will take approximately 7 minutes, vs. 30 to 60 minutes with IV infusion, according to a Genentech press release.
The FDA based approval of the subcutaneous injection formulation on results of the randomized phase 1B/phase 3 IMscin001 trial.
The multicenter trial included 371 adults with locally advanced or metastatic NSCLC who had not received prior immunotherapy and whose disease had progressed after platinum-based chemotherapy.
Researchers randomly assigned trial participants 2:1 to subcutaneous atezolizumab and hyaluronidase-tqjs or IV atezolizumab. Treatment continued until unacceptable toxicity or disease progression.
Atezolizumab exposure served as the primary outcome measure. Investigators also assessed pharmacokinetic endpoints, along with overall response rate, PFS and OS.
The trial met its primary endpoints, with results showing comparable levels of atezolizumab in the blood during a specific dosing interval, observed serum Ctrough and model-predicted area under the curve, according to a Genentech press release.
Results showed confirmed ORRs of 9% with subcutaneous atezolizumab and hyaluronidase-tqjs vs. 8% for IV atezolizumab. Investigators noted “no notable differences” in OS or PFS between formulations, according to an FDA press release.
Any-grade adverse events that occurred among at least 10% of participants included fatigue, musculoskeletal pain, cough, dyspnea and decreased appetite.
References:
- FDA approves atezolizumab and hyaluronidase-tqjs for subcutaneous injection (press release). Available at: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-atezolizumab-and-hyaluronidase-tqjs-subcutaneous-injection. Published Sept. 12, 2024. Accessed Sept. 13, 2024.
- FDA approves Genentech’s Tecentriq Hybreza, the first and only subcutaneous anti-PD-(L)1 cancer immunotherapy (press release). Available at: https://www.gene.com/media/press-releases/15035/2024-09-12/fda-approves-genentechs-tecentriq-hybrez. Published Sept. 12, 2024. Accessed Sept. 13, 2024.
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