LEUKEMIAS

An updated analysis of obinutuzumab alone or in combination with chemotherapy for patients with treatment-naïve or relapsed/refractory chronic lymphocytic leukemia detected no new safety signals. Investigators in the phase IIIb GREEN trial also found overall response rates greater than 80% at 3 months post-treatment in some patients.

Romyelocel-L (human myeloid progenitor cells) has been granted a Regenerative Medicine Advanced Therapy designation by the FDA for the prevention of bacterial and fungal infections in patients with acute myeloid leukemia undergoing induction chemotherapy, according to Cellerant Therapeutics, Inc, the manufacturer of the therapy. RMAT designation holds similar advantages to breakthrough therapy designation.

CPX-351, a fixed-combination of daunorubicin and cytarabine, has been recommended for approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use for the treatment of adult patients with newly diagnosed therapy-related acute myeloid leukemia or AML with myelodysplasia-related changes.

Based on data from the phase II BRIGHT 1003 study, the FDA has granted a priority review to a new drug application for glasdegib for use in combination with chemotherapy for the frontline treatment of patients with acute myeloid leukemia, according to Pfizer, the developer of the investigational oral smoothened inhibitor.

William B. Donnellan, MD, was recently promoted to director of Leukemia/Myelodysplastic Syndrome Research at the Sarah Cannon Research Institute in Nashville, Tennessee. Donnellan has served as an investigator of hematologic malignancies since 2014 at the Sarah Cannon Research Institute.

According to long-term follow-up data from the phase III CLL11 study, treatment with obinutuzumab combined with chlorambucil reduced the risk of death by 24% versus rituximab plus chlorambucil in treatment-naïve patients with chronic lymphocytic leukemia with comorbidities. These findings were presented at the 2018 European Hematology Association Congress.

Neil E. Kay, MD, a professor of medicine at the Mayo Clinic, discusses the challenges that arise when treating a patient with relapsed chronic lymphocytic leukemia (CLL). Most times, responses in this setting are short lived.

Matthew S. Davids, MD, MMSc, discusses the findings with duvelisib plus fludarabine-cyclophosphamide-rituximab as a frontline therapy for younger patients with CLL, as well as the potential future for this agent in the treatment of patients with CLL.

Based on survival data from the phase III TOWER study, blinatumomab has been granted full marketing authorization by the European Commission for the treatment of adult patients with Philadelphia chromosome-negative relapsed/refractory B-cell precursor acute lymphoblastic leukemia, according to Amgen, the developer of the anti-CD19 immunotherapy.

Michael R. Grunwald, MD,&nbsp;discusses new and emerging agents in AML and ALL, as well as sequencing and toxicity challenges with these treatments.<br /> &nbsp;

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.