Javier A. Pinilla-Ibarz, MD, PhD, senior member, Moffitt Cancer Center, discusses the FDA approval of moxetumomab pasudotox for the treatment of adult patients with hairy cell leukemia who have received at least 2 prior lines of therapy.

In a single-arm, open-label study of 80 patients with hairy cell leukemia, the CD22-directed recombinant immunotoxin moxetumomab pasudotox induced a complete remission lasting for over 180 days for 30% of patients, as well as an objective response rate of 75%.

The approval is for patients that have recieved at least 2 prior lines of therapy, including treatment with a purine nucleoside analog.

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Dr. Pinilla-Ibarz on the FDA Approval of Moxetumomab Pasudotox in Hairy Cell Leukemia

Javier A. Pinilla-Ibarz, MD, PhD, senior member, Moffitt Cancer Center, discusses the impact of venetoclax (Venclexta) in chronic lymphocytic leukemia (CLL).

Venetoclax has revolutionized the face of second-line treatment for patients with CLL, says Pinilla-Ibarz. Venetoclax has facilitated the possibility of limited duration of treatment, as well as the potential to achieve minimal residual disease (MRD) negativity, adds Pinilla-Ibarz.

In June, the FDA approved venetoclax for the treatment of patients with CLL with or without 17p deletion, following at least 1 prior line of therapy. The BCL-2 inhibitor is also approved for use in combination with rituximab (Rituxan) in the same patient population. The FDA recently added MRD data from the phase III MURANO trial to the second-line label. In the MURANO trial, the rate of MRD negativity was 53% following 9 months of treatment with the combination.

Venetoclax has garnered a lot of excitement in the field, explains Pinilla-Ibarz. Now, interest has turned toward combination regimens, some of which include other monoclonal antibodies as well as ibrutinib (Imbruvica).

Dr. Pinilla-Ibarz on the Impact of Venetoclax in CLL

Javier A. Pinilla-Ibarz, MD, PhD, senior member, Moffitt Cancer Center, discusses the role of chemotherapy in patients with chronic lymphocytic leukemia (CLL).

There is no doubt that chemotherapy is beginning to fade in the treatment paradigm, says Pinilla-Ibarz. At the 2018 ASH Annual Meeting, physicians are expecting to hear the data on the ALLIANCE study, which is comparing single-agent ibrutinib (Imbruvica) with the combination of ibrutinib, rituximab (Rituxan) and bendamustine (Treanda) in the frontline setting, says Pinilla-Ibarz.

At this point, most of the guidelines recommend chemotherapy in the form of fludarabine-cyclophosphamide-rituximab (FCR) for patients age 65 or younger who have

-mutated surface immunoglobulin. Data in this patient population show long-term benefit and evidence of possible cure with this regimen, says Pinilla-Ibarz. Bendamustine plus rituximab is still an option for these older patients, but Pinilla-Ibarz says patients should be counseled on an individualized basis to determine what regimen to pursue.

Dr. Pinilla-Ibarz on the Role of Chemotherapy in CLL

Javier A. Pinilla-Ibarz, MD, PhD senior member, Moffit Cancer Center, discusses the recent advances in chronic myeloid leukemia (CML). Pinilla-Ibarz says that he and colleagues do not expect much in the field after other recent advancements, but he is still surprised to see what is being concentrated on today.

One advancement in CML is the discontinuation of a drug. Pinilla-Ibarz says that there could be a lot of success there if we find out who the right patient is for this. This is a big goal for CML right now, as is the possibility of adding a second drug to tyrosine kinase inhibitors. If this is done, patients could have a deeper molecular response to treatment.

Javier A. Pinilla-Ibarz, MD, PhD

Articles

Dr. Pinilla-Ibarz on the FDA Approval of Moxetumomab Pasudotox in Hairy Cell Leukemia

Dr. Pinilla-Ibarz on the Impact of Venetoclax in CLL

Dr. Pinilla-Ibarz on the Role of Chemotherapy in CLL

Dr. Pinilla-Ibarz Discusses Advancements in CML