Phase III trial begins for oral PTCL drug


Millennium and Takeda Pharmaceutical have announced the initiation of an international, phase III, randomized, open-label, multi-center trial investigating the company's oncology product MLN8237 (alisertib).

The trial will divide patients into two arms, one receiving oral alisertib and the other receiving a selected single chemotherapeutic agent, in patients diagnosed with relapsed or refractory peripheral T-cell lymphoma (PTCL).

The trial's 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).

According to Millennium, MLN8237 (alisertib) is an oral, selective, inhibitor of Aurora A kinase, a protein understood to be over-expressed in a number of cancers. Cells need Aurora A kinase to divide, thus making it a good therapeutic target for an inhibitor.

Source: MarketWatch

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