Takeda Discontinues Alisertib Phase 3 Trial in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma

Takeda Discontinues Alisertib Phase 3 Trial in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma

Takeda Pharmaceutical Company Limited recently announced its decision to discontinue a Phase 3 clinical trial that was evaluating the company’s drug candidate alisertib (MLN8237) as a treatment for patients suffering with relapsed or refractory peripheral T-cell lymphoma (PTCL). This decision was made after results of an interim analysis determined that the trial is unlikely to meet its primary endpoint, which involves superior progression-free survival (PFS) over the standard-of-care during a treatment setting.

“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 in a recent press release. “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.”

According to Takeda, the patients that were taking part in the study and treated with Alisertib can continue with the therapy if researchers believe that it offers benefits to the patients. No safety issues were observed upon this treatment. Alisertib is a selective inhibitor of Aurora A kinase, a protein specifically relevant for proper cellular division. Takeda has been investigating the drug for small cell lung cancer treatment. The kinase has been found to be over-expressed in many cancers, and its inhibition represents a novel approach in cancer research.

Patients enrolled in the study should contact their clinical study researchers regarding any potential questions and before changing their medications. The company is working to provide study participants with appropriate care. More information can be found in the Takeda’s website at www.takeda.com.

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