A new chemotherapy drug being investigated for its potency against two types of cancer was found by scientists at Houston Methodist and seven other institutions to be effective in about one-third of the 58 patients who participated in a phase I study.
The drug, alisertib or MLN8237, inhibits the enzyme aurora A kinase, which is known to be very active during cell division. The present study, published in the journal Investigational New Drugs, looks at the safety, tolerability, and preliminary success of alisertib in treating non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL).
"An advantage with this drug is it is oral and very effective in a significant number of patients with aggressive lymphoma when used at that dose for 7 days out a 21 day cycle," said hematologist Swaminathan Iyer, M.D., who led the multi-site study.
Drugs commonly used to treat NHL and CLL are chemotherapeutic drugs and some biological targeted agents such as the monoclonal antibodies rituximab, ofatumumab and obinutuzumab with varying degrees of success.
Although about 1/2 of patients participating in the phase I study experienced side effects most of which were manageable events, Iyer said that is not unusual for such biologic (non chemotherapy) drugs.
"The side effects were fairly tolerable in this study," Iyer said. "We would like to see more information from a larger group of patients to fully understand the drug's safety and tolerability for those experiencing the middle-to-later stages of these diseases."
Iyer and his group recommend 50 mg, twice-daily doses of alisertib for the advanced phase trials of the drug, which Iyer says has begun enrollment.
Alisertib is not yet approved for general medical use by the FDA. Its impact on T cell lymphoma is being investigated in a separate, phase III trial for a specific type of lymphoma called the T cell lymphomas. Houston Methodist is a participating study site for that project. Initial phase II reports in these T cell lymphomas showed a 57% response, the highest ever noted for any single agent in this disease entity.
Also contributing to this work were Kevin Kelly (University of Texas Health Science Center at San Antonio), Thomas Shea (University of North Carolina Chapel Hill), André Goy (Hackensack University Medical Center), Jesus Berdeja (Sarah Cannon Research Institute), Craig Reeder (Mayo Clinic Arizona), Kevin Mcdonagh (University of Kentucky), and Xiaofei Zhou, Hadi Danaee, Hua Liu, Jeffrey Ecsedy, Huifeng Niu, and Ely Benaim (Takeda Pharmaceuticals International Company). The work was funded by Millennium: The Takeda Oncology Company.
To speak with Swaminathan Iyer or to learn more about the ongoing trial, please contact David Bricker, Houston Methodist, at 832-667-5811 or firstname.lastname@example.org.
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