Alisertib Safe, Active for Breast, Small-Cell Lung Cancer

According to a new study published in the journal The Lancet Oncology, researchers have found that alisertib, an investigational aurora kinase A inhibitor, shows activity and is safe in patients with solid tumors, especially those with breast and small-cell lung cancer (SCLC).

For the international phase 1/2 study, researchers enrolled patients with breast cancer, SCLC, non-small-cell lung cancer (NSCLC), head and neck squamous-cell carcinoma, and gastro-oesophageal carcinoma. By May 31, 2013, 249 patients had been treated with alisertib 50mg orally twice daily for 7 days followed by a break of 14 days in 21-day cycles.

Results showed that among assessable patients, 18% (95% CI: 9 – 32) of 49 patients with breast cancer, 21% (95% CI: 10 – 35) of 48 patients with SCLC, 4% (95% CI: 0 – 22) of 23 patients with NSCLC, 9% (95% CI: 2 – 21) of 45 individuals with head and neck squamous-cell carcinoma, and 9% (95% CI: 2 – 20) of people with gastro-oesophageal adenocarcinoma achieved partial responses.

In regard to safety, the most frequent severe adverse events associated with alisertib treatment were neutropenia, leukoepenia, and anemia. Adverse events were similar across treatment arms.

The authors conclude that the findings support further study of alisertib in patients with solid tumors, particularly those with breast cancer and SCLC.

Reference

1. Melichar B, Adenis A, Lockhard AC, et al. Safety and activity of alisertib, an investigational aurora kinase A inhibitor, in patients with breast cancer, small-cell lung cancer, non-small-cell lung cancer, head and neck squamous-cell carcinoma, and gastro-oesophageal adenocarcinoma: a five-arm phase 2 study. Lancet Oncol. 2015. [Epub ahead of print]. doi: 10.1016/S1470-2045(15)70051-3.