Dr. Furman on Trials Examining Ibrutinib's Safety in CLL

Richard R. Furman, MD, director of the Chronic Lymphocytic Leukemia (CLL) Research Center and a senior member of the Center for Lymphoma and Myeloma at the Weill Cornell Medical Center, discusses the safety profile of the oral BTK inhibitor ibrutinib in both relapsed/refractory and treatment naive patients with CLL.

A preliminary phase II trial examining ibrutinib as a monotherapy in refractory populations found impressive response rates, states Furman. However, in this population there was a great deal of toxicities, including secondary myelodysplasia and AML, Richter's transformation, or infections. These added toxicities were due to the large amount of prior therapies that patients had received, Furman explains.

These toxicities prompted a phase II study looking at ibrutinib in previously untreated patients with CLL. In General, Furman explains, this trial did not find any clear ibrutinib-associated toxicities. Overall, the trial found the agent to be well tolerated and reasonably safe.

The phase III trial examining ibrutinib is currently underway. Furman is optimistic that this trial will lead to the FDA approval of ibrutinib in CLL.