Alisertib Fails to Meet Primary Endpoint in Sarcoma Study
Alisertib failed to meet its primary response rate endpoint, though it was associated with a promising progression-free survival rate, for sarcoma.
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.
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%).
- 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]