Robert L. Talley, MD, hematologist/medical oncologist, Centerpoint Medical Center, Sarah Cannon Cancer Institute, discusses clinical trials for patients with chronic leukemias.

The ENESTop protocol examined the long-term follow-up of tyrosine kinase inhibitors (TKIs) in patients with chronic myeloid leukemia (CML). Updated results from the phase II, open-label study that evaluated treatment-free remission (TFR) after discontinuation of second-line nilotinib (Tasigna) showed that TFR continued after discontinuation of second-line nilotinib. Talley said that the updated results show good continual responses from the TKIs with a low incidence of side effects.

The other abstract looked at moxetumomab pasudotox for the treatment of adult patients with relapsed/refractory hairy cell leukemia (HCL), explains Talley. Moxetumomab is an anti-CD22 recombinant. The ongoing international study has shown a substantial response rate as well as minimal residual disease negativity through immunohistochemistry.

In April, the agent received a priority review designation by the FDA. The application followed the results of the phase III 1053 study, which met its primary endpoint of durable complete responses in adult patients with relapsed/refractory HCL.

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Dr. Talley on Clinical Trials for Patients With Chronic Leukemias

Robert L. Talley, MD, hematologist/medical oncologist, Centerpoint Medical Center, Sarah Cannon Cancer Institute, discusses the CAPTIVATE trial in patients with chronic lymphocytic leukemia (CLL).

Ibrutinib (Imbruvica) can certainly be used long-term, says Talley. It is a very effective agent and may result in long-term responses, but it has to be given continuously, explains Talley. Many of the currently available biologic agents and monoclonal antibodies are expensive, which has prompted concerns over rising healthcare costs.

The frontline combination of ibrutinib and venetoclax (Venclexta) in patients with CLL was limited to 12 cycles. At the end of 12 combined cycles, there was a randomization for placebo versus ibrutinib alone. The combination demonstrated an 100% objective response rate. The complete remission rate was 36% in 11 patients with available bone marrow data.

Both agents are very effective alone and work quite differently, but complement each other when combined, says Talley. Ibrutinib has the ability to decrease the tumor lysis risk, which allows for better safety with venetoclax, Talley concludes.

Robert L. Talley, MD

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Dr. Talley on Clinical Trials for Patients With Chronic Leukemias

Dr. Talley on the CAPTIVATE Trial in CLL