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The Food and Drug Administration (FDA) has approved Tecentriq (atezolizumab) for the treatment of adult and pediatric patients 2 years of age and older with unresectable or metastatic alveolar soft part sarcoma (ASPS).
The approval was based on data from an open-label, single-arm phase 2 study (Study ML39345; ClinicalTrials.gov Identifier: NCT03141684) that evaluated the efficacy and safety of atezolizumab, a PD-L1 blocking antibody, in 49 patients 2 years of age and older with histologically or cytologically confirmed ASPS that was not curable by surgery, and an Eastern Cooperative Oncology Group performance status of 2 or less.
Adult patients received atezolizumab 1200mg intravenously (IV) and pediatric patients received 15mg/kg (up to a maximum of 1200mg) IV once every 21 days until disease progression or unacceptable toxicity. The primary endpoints were overall response rate (ORR) and duration of response (DoR).
Results showed an ORR of 24% (95% CI, 13-39); all patients were reported to have a partial response. Among the 12 responders, 67% achieved a duration of response of at least 6 months, and 42% achieved a duration of response of at least 12 months.
The most common adverse reactions reported in the trial were musculoskeletal pain, fatigue, rash, cough, nausea, headache, hypertension, vomiting, constipation, dyspnea, dizziness, hemorrhage, insomnia, diarrhea, pyrexia, anxiety, abdominal pain, hypothyroidism, decreased appetite, arrhythmia, influenza-like illness, allergic rhinitis, and weight fluctuations.
Tecentriq is supplied as a preservative-free solution for IV infusion in a single-dose vial (840mg/14mL or 1200mg/20mL).
References
- FDA grants approval to atezolizumab for alveolar soft part sarcoma. News release. US Food and Drug Administration. December 9, 2022. Accessed December 12, 2022. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-approval-atezolizumab-alveolar-soft-part-sarcoma.
- Tecentriq. Package insert. Genentech; 2022. Accessed December 12, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761034s047lbl.pdf.
This article originally appeared on MPR
