Millennium reports ongoing MLN8237 Phase II study results on non-Hodgkin lymphoma

Millennium: The Takeda Oncology Company today announced the presentation of results from an ongoing Phase II study of MLN8237, an investigational Aurora A kinase inhibitor, in patients with relapsed/refractory aggressive B-cell and T-cell non-Hodgkin lymphoma (NHL). These data were reported in an oral presentation at the 11^th International Congress on Malignant Lymphoma, held June 15-18 in Lugano, Switzerland.

"There are few treatment options available for patients with these aggressive types of lymphoma," said Nancy Simonian, M.D., Chief Medical Officer, Millennium. "We are encouraged by the activity MLN8237 has shown in these heavily pre-treated, relapsed or refractory patient populations, and look forward to further study."

Multicenter Phase II Trial of MLN8237, an Investigational Inhibitor of Aurora A Kinase (AAK), in Patients with Aggressive B-cell and T-cell Non-Hodgkin Lymphoma (NHL)

Results from the ongoing multicenter Phase II study were reported in 48 patients with relapsed/refractory aggressive B-cell or T-cell NHL. Eighty-three percent>

The results from 41 evaluable patients were presented by Jonathan Friedberg, M.D., M.M.Sc., Chief of Hematology/Oncology at the James P. Wilmot Cancer Center at the University of Rochester Medical Center and showed:

• The overall response rate (ORR) was 32 percent
• The complete response (CR) rate was 12 percent
• The ORR was 57 percent
• The most common grade 3 or higher adverse events were neutropenia (65 percent), thrombocytopenia (31 percent), stomatitis (15 percent) and fatigue (6 percent)
• The most common nonhematologic adverse events were fatigue (65 percent), diarrhea (60 percent), alopecia (48 percent) and somnolence (44 percent)

"These data suggest that MLN8237 shows promising activity, particularly for T-cell lymphoma patients, and these results warrant further investigation in an aggressive NHL population," said Dr. Friedberg.