FDA Approves Subcutaneous Tecentriq Formulation

FDA Approves Subcutaneous Tecentriq Formulation

The Food and Drug Administration (FDA) approved Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs), a subcutaneous injection, for all previously approved indications of the intravenous formulation Tecentriq (atezolizumab) including non-small cell lung cancer (NSCLC), melanoma, hepatocellular carcinoma (HCC) and alveolar soft part sarcoma.

Of note, subcutaneous injections are delivered beneath the skin, whereas intravenous formulations are administered into a vein.

This approval was based on findings from the IMscin001 trial, which assessed the subcutaneous injection of Tecentriq Hybreza in adults with locally advanced or metastatic NSCLC who did not previously receive cancer immunotherapy and whose disease progressed after platinum-based chemotherapy, according to a release from the FDA. In this trial, 371 patients were randomly assigned to receive subcutaneous Tecentriq Hybreza or intravenous Tecentriq. Treatment was given until disease progression or unacceptable toxicity.

The main area of interest for researchers conducting this study was exposure to Tecentriq. Other areas of interest included progression-free survival (PFS; the time during and after treatment when a patient with cancer lives without disease worsening), overall response rate (ORR; the effectiveness of a treatment, listed as a percentage of patients with a partial or complete response to therapy) and overall survival (OS; the time when a patient with cancer is still alive).

The geometric mean ratio (a measurement of efficacy of different treatments) of subcutaneous Tecentriq and intravenous Tecentriq for the first cycle was 1.05 (meaning that there was minimal difference in longer survival between both groups). This met the lower limit of the geometric mean ratio above the prespecified threshold of 0.8 for comparability, according to the release.

There were no noteworthy differences in PFS, ORR or OS between the different formulations of Tecentriq. The confirmed ORR was 9% in the subcutaneous arm compared with 8% in the intravenous arm.

The most common side effects, occurring in at least 10% of patients in the study, included musculoskeletal pain, fatigue, dyspnea (shortness of breath), cough and decreased appetite. According to the published data in the Annals of Oncology, there were no new safety concerns with the subcutaneous formulation.

In the study, researchers wrote, “Subcutaneous administration has emerged as an alternative route to [intravenous] infusion for the delivery of large therapeutic proteins. Studies show that patients prefer the [subcutaneous formulation] compared with the [intravenous] route of administration due to reduced pain and discomfort, shorter administration time and reduced time in the clinic. The [subcutaneous] formulations have also been shown to yield meaningful time and cost savings at health care centers.”

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