FDA Approves Atezolizumab for Alveolar Soft Part Sarcoma

The FDA has approved atezolizumab (Tecentriq) to treat adults and children aged 2 years or older with unresectable or metastatic alveolar soft part sarcoma, according to a press release from the agency.

The FDA based the approval on findings of the Study ML39345 (NCT03141684) which comprised 49 patients with histologically or cytologically confirmed unresectable or metastatic alveolar soft part sarcoma.

Among patients who were treated with atezolizumab at an intravenous dose of 1200 mg/kg for adults and 15 mg/kg for children for 21 days until progression or unacceptable toxicity, the overall response rate was 24% (95% CI, 13%-39%). Among responders, the 6-month duration of response rate was 67% and the 12-month rate was 42%.

Atezolizumab was given at a recommended dose of 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks until disease progression or unacceptable toxicity. Moreover, for the pediatric population, it was 15 mg/kg every 3 weeks until progression or toxicity.

Frequent adverse effects included musculoskeletal pain (67%), fatigue (55%), rash (47%), cough (45%), nausea (43%), headache (43%), hypertension (43%), vomiting (37%), constipation (33%), dyspnea (33%), dizziness (29%), hemorrhage (29%), insomnia (27%), diarrhea (27%), pyrexia (25%), anxiety (25%), abdominal pain (25%), hypothyroidism (25%), decreased appetite (22%), arrhythmia (22%), influenza-like illness (18%),weight decreased (18%), and allergic rhinitis (16%), and weight increased (16%).

Reference

FDA grants approval to atezolizumab for alveolar soft part sarcoma. News release. FDA. December 9, 2022. Accessed December 10, 2022. https://bit.ly/3VKSSbj