Millennium: The Takeda Oncology Company with its parent company Takeda Pharmaceutical Company Limited, has initiated an international phase 3 clinical trial evaluating MLN8237 in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL), an aggressive form of lymphoma. The multi-centre study with MLN8237, an investigational, oral, selective inhibitor of Aurora A kinase, will be conducted in Europe, North America, Latin America and the Asia-Pacific region.

“There is a significant unmet medical need for patients suffering from PTCL.  As a leader in the development of novel therapies Millennium continues to work toward filling that need,” said Karen Ferrante, M.D., chief medical officer, Millennium.  “MLN8237 is being explored across a broad range of haematological malignancies and solid tumours. The initiation of this trial represents another major achievement in advancing the Millennium pipeline.”

The study is a phase 3, randomized, two-arm, open-label, multi-centre, international trial of MLN8237 (alisertib) or investigator’s choice (selected single agent) in patients with relapsed or refractory PTCL.  The primary endpoints are overall response rate (ORR) and progression-free survival (PFS).  Secondary endpoints include safety, complete response (CR) rate, overall survival (OS), and time to progression (TTP).

MLN8237 (alisertib) is an oral, selective, inhibitor of Aurora A kinase.  Aurora A kinase is required for cells to divide and has been shown to be over-expressed in a variety of cancers.   Inhibition of Aurora A kinase represents a novel approach in cancer research.

Peripheral T-cell lymphoma (PTCL) comprises a group of rare and usually aggressive non-Hodgkin lymphomas (NHL) that develop from mature T-cells, which is one of the lymphocytes derived from myeloid stem cell, differentiated and matured in the thymus gland. Peripheral T-cell lymphoma represents a spectrum of T-cell lymphomas and accounts for approximately 10 per cent to 15 per cent of all NHL cases in the United States.