New drug for non-Hodgkin lymphoma and chronic leukemia succeeds in phase I

A new chemotherapy drug being investigated for its potency against two types of cancer was found 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 Investigational New Drugs (2014; doi:10.1007/s10637-013-0050-9), 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 of a 21 day cycle," said hematologist Swaminathan Iyer, MD, of Houston Methodist in Texas, who led the multisite study.

NHL and CLL are commonly treated with chemotherapeutic drugs and with some biological targeted agents such as the monoclonal antibodies rituximab, ofatumumab, and obinutuzumab. These treatments have varying degrees of success.

Although about half of patients participating in the phase I study experienced side effects, most of these were manageable events, Iyer said. He explained that these are not unusual for such biologic, or nonchemotherapy, 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. Iyers stated that the advanced phase trials have 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 (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.

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