Alisertib failed to meet its primary response rate endpoint, though it was associated with a promising progression-free survival rate, for patients with advanced/metastatic sarcoma, according to a study published in the journal Annals of Oncology.1

Preclinical models demonstrate that alisertib inhibits (Aurora Kinase A) AURKA in multiple sarcoma subtypes; researchers evaluated the activity and tolerability of alisertib in this phase 2 trial.

Investigators enrolled 72 patients, of which 12 had liposarcoma, 10 had leiomyosarcoma, 11 had undifferentiated sarcoma, 10 had malignant peripheral nerve sheath tumor, and 29 had other sarcoma types.

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All patients received alisertib 50 mg orally twice daily on days 1 to 7 every 21 days.

There were 2 confirmed partial responses, both occurring in patients with angiosarcoma, as well as 1 unconfirmed partial response in a patient with dedifferentiated chondrosarcoma.

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The 12-week progression-free survival rate was 73% in patients with liposarcoma, 44% in leiomyosarcoma, 36% in undifferentiated sarcoma, 60% in malignant peripheral nerve sheath tumor, and 38% in patients with other subtypes.

The most common grade 3 to 4 adverse events included neutropenia (42%), leukopenia (22%), anemia (14%), platelet count decreased (14%), and oral mucositis (12%).                           


  1. Dickson MA, Mahoney MR, Tap WD, et al. Phase II study of MLN8237 (alisertib) in advanced/metastatic sarcoma. Ann Oncol. 2016 Aug 8. doi: 10.1093/annonc/mdw281 [Epub ahead of print]