LEUKEMIAS

An overall response rate of&nbsp;41.6% (95% CI, 32.9-50.8) was induced with the use of ivosidenib in patients with&nbsp;<em>IDH1</em>-positive relapsed/refractory acute myeloid leukemia, according to data presented at the 2018 ASCO Annual Meeting&nbsp;and published simultaneously online in the <em>New England Journal of Medicine</em>.

Based on data from the phase III MURANO trial, venetoclax has been granted a regular approval by the FDA&nbsp;for the treatment of patients with chronic lymphocytic leukemia or small lymphocytic lymphoma, with or without 17p deletion, who has received at least 1 prior therapy.

According to results presented at the 2018 ASCO Annual Meeting,&nbsp;moxetumomab pasudotox, a first-in-class recombinant immunotoxin targeting CD22, demonstrated deep and durable responses in a substantial proportion of pretreated patients with relapsed/refractory hairy cell leukemia.

Treatment-naive patients with chronic lymphocytic leukemia achieved high rates of&nbsp;minimal residual disease&ndash;negative status of 77% with peripheral blood testing after 6 cycles from treatment with ibrutinib (Imbruvica) and venetoclax (Venclexta). Additionally, patients in the CAPTIVATE trial, wihch was presented during the 2018 ASCO Annual Meeting, achieved an objective response rate of 100%.

Based on data from the ongoing phase III ADMIRAL study, a new drug application for&nbsp;gilteritinib has been granted a priority review by the FDA for&nbsp;the treatment of adult patients with <em>FLT3</em> mutation&ndash;positive relapsed or refractory acute myeloid leukemia,&nbsp;according to Astellas Pharma, the manufacturer of the FLT3 inhibitor.

According to topline results from the phase III ILLUMINATE trial, the&nbsp;combination of ibrutinib and obinutuzumab improved progression-free survival compared with chlorambucil&nbsp;plus obinutuzumab&nbsp;in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.

The combination of prexigebersen, a Liposomal Grb2 Antisense oligodeoxynucleotide, and low-dose cytarabine was associated with an overall response rate of 47% in elderly patients with acute myeloid leukemia, according to findings from an ongoing phase II trial.

Neil E. Kay, MD, professor of medicine at the Mayo Clinic, addresses the &ldquo;Big 4&rdquo; in salvage therapies for patients with relapsed/refractory chronic lymphocytic leukemia, including a newer therapy coming down the pipeline now.

According to findings from the phase III QuANTUM-R study, overall survival was improved with quizartinib compared with chemotherapy in patients with&nbsp;<em>FLT3</em>-ITD&ndash;positive relapsed/refractory acute myeloid leukemia after first-line treatment with or without hematopoietic stem cell transplantation.<br /> &nbsp;

According to results from the MABLE trial, the combination of rituximab plus bendamustine demonstrated significant value as a frontline treatment option for fludarabine-ineligible patients with chronic lymphocytic leukemia.

Results of an interim analysis from a small phase I trial presented at the 2018 American Society of Pediatric Hematology/Oncology Conference showed that CAR T-cell therapy can&nbsp;induce next generation sequencing negativity in patients with relapsed/refractory acute lymphoblastic leukemia, suggesting a &ldquo;synergistic&rdquo; relationship with hematopoietic cell transplant that could enhance patient outcomes.

Results from a recent study conducted at the University of Pennsylvania may demonstrate why some patients with chronic&nbsp;lymphocytic leukemia are resistant to tisagenlecleucel, while potentially providing a pathway to enhance patient response.

The combination of bendamustine and rituximab induced a 12-month progression-free survival of 78.6% for patients with chronic lymphocytic leukemia, suggesting that the combination is an effective first salvage regimen.

The FDA approved several indications throughout the month of April 2018.&nbsp;A number of drugs were granted priority review and Fast Track designation. The FDA also halted all clinical trials using&nbsp;tazemetostat as treatment, and new initiatives were introduced&nbsp;to help ease the development of genetic and genomic-based tests.&nbsp;Check out our list of all FDA happenings from April 2018.

Based on data from the ongoing phase III ADMIRAL study, Astellas Pharma, the manufacturer of&nbsp;gilteritinib, has announced the submission of a new drug application to the FDA seeking approval for the FLT3 inhibitor as a treatment for adult patients with <em>FLT3</em> mutation&ndash;positive relapsed or refractory acute myeloid leukemia.