FDA approves Tecentriq for unresectable or metastatic alveolar soft part sarcoma
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The FDA approved atezolizumab for adults and children aged 2 years or older with unresectable or metastatic alveolar soft part sarcoma.
Atezolizumab (Tecentriq, Genentech) is an anti-PD-L1 monoclonal antibody.
The agency based approval of the new indication on results of the open-label, single-arm ML39345 study, which evaluated the efficacy of atezolizumab in 47 adults and two pediatric patients (median age, 31 years; range, 12-70) with unresectable or metastatic alveolar soft part sarcoma (ASPS).
Researchers screened eligible patients for the study by histologic or cytologic confirmation of ASPS deemed incurable via surgery. They excluded individuals with primary central nervous system malignancy or symptomatic CNS metastases, as well as patients with significant liver disease or a history of idiopathic pulmonary fibrosis, pneumonitis, organizing pneumonia or active pneumonitis on imaging.
Adults received 1,200 mg and pediatric patients received 15 mg/kg (with a maximum of 1,200 mg) via IV once every 21 days until disease progression or unacceptable toxicity.
Overall response rate and duration of response (DOR) served as the main efficacy outcome measures.
Results showed an ORR of 24% (95% CI, 13-39). Of the 12 patients who experienced an objective response, 67% had a DOR of at least 6 months, while 42% had a DOR of at least 12 months.
The most common adverse reactions included musculoskeletal pain (67%), fatigue (55%), rash (47%), cough (45%), and nausea, headache and hypertension (43% each).
The application involving atezolizumab previously had been granted FDA priority review, breakthrough designation and orphan drug designation.
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