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news.Takeda Pharmaceutical has decided to terminate the Phase III trial of alisertib (MLN8237) for patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).
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Alisertib is an oral, selective, inhibitor of Aurora A kinase being investigated by Takeda to treat small cell lung cancer.
The decision to discontinue follows the results of a pre-specified interim analysis that indicated the trial is unlikely to meet the primary endpoint of superior progression-free survival (PFS) over the standard-of-care in this treatment setting.
The company said it will continue to investigate the utility of alisertib in small cell lung cancer (SCLC).
Takeda Oncology Therapeutic Unit global head Michael Vasconcelles said: "Takeda has a deep and long-standing commitment to developing innovative cancer therapies.
"While we are disappointed that alisertib will not be further investigated for relapsed or refractory peripheral T-cell lymphoma, we are optimistic about alisertib’s clinical development program in small cell lung cancer.
"The randomized Phase II study of alisertib in small cell lung cancer will continue as planned and is currently underway. Takeda also continues to support investigator initiated research with alisertib and will evaluate its potential use in other oncology indications going forward."
According to the company, patients enrolled in this Phase III trial who are being treated with alisertib may continue treatment if they are considered to be benefitting from treatment, and no safety concerns are present.
The company said that it is working with trial investigators and local regulatory authorities to ensure that patients who participated in the trial receive appropriate care.