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Takeda Announces Termination of Alisertib Phase 3 Trial in Relapsed or Refractory Peripheral T-cell Lymphoma

Takeda Remains Committed to Continuing the Ongoing Alisertib Clinical Development Program

Cambridge, MA and Osaka, Japan, May 12, 2015 – Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that it has decided to discontinue the Phase 3 trial of alisertib (MLN8237) for patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) following the results of a pre-specified interim analysis that indicated the study is unlikely to meet the primary endpoint of superior progression-free survival (PFS) over the standard-of-care in this treatment setting. Takeda continues to investigate the utility of alisertib in small cell lung cancer (SCLC).

“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,” said Michael Vasconcelles, M.D., Global Head of the Takeda Oncology Therapeutic Unit. “The randomized Phase 2 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.”

Patients enrolled in the Phase 3 PTCL clinical 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. Patients are encouraged to consult their study investigators to address any questions, and before making any changes to their medication. Takeda is working with trial investigators and local regulatory authorities to ensure that patients who participated in the study receive appropriate care. For additional information, please visit www.takeda.com.

About Alisertib
Alisertib (MLN8237) is an oral, selective, inhibitor of Aurora A kinase being investigated by Takeda for the treatment of small cell lung cancer. Aurora A kinase is required for cells to divide properly and has been shown to be over-expressed in a variety of cancers, and inhibition of Aurora A kinase represents a novel approach in cancer research.

About Takeda
Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for people worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, www.takeda.com.

Contact:
Elizabeth Pingpank
elizabeth.pingpank@takeda.com 
+1-617-444-1495

Takeda Pharmaceutical Company Limited
Corporate Communications Department
Tel +81-3-3278-2037