HEMATOLOGY

Jorge E. Cortes, MD, discusses the results from the ENESTFreedom study, which evaluated the use of nilotinib as a treatment for patients with BCR-ABL1&ndash;positive chronic myeloid leukemia in the chronic phase.<br /> &nbsp;

New data from the phase II/III IMerge trial show that imetelstat may allow for transfusion independence for patients with debilitating anemia caused by myelodysplastic syndrome,&nbsp;according to results presented at the&nbsp;2019 EHA Congress.<br /> &nbsp;

A cohort of cancer centers was selected to serve as models for identifying key strategies for racial and ethnic minority group engagement in clinical trials. On the basis of several qualifying criteria, such as sustained accrual of minorities into clinical cancer research, an established minority population &ge;10% in the overall catchment, an established clinical trial infrastructure, and a formal community outreach program, the investigators identified 8 cancer centers for participation.

In a case-based-style discussion, Tanios S. Bekaii-Saab, MD, and Wells Messersmith, MD, reviewed the treatment of patients with colorectal cancer whose tumors express rare gene mutations or molecular signatures, such as <em>NTRK</em> fusions.

Combined treatment with ibrutinib and venetoclax was shown to be a safe and effective first-line oral regimen for high-risk and older patients with chronic lymphocytic leukemia, according to findings from an open-label phase II trial published recently in the<em> New England Journal of Medicine</em>.<br /> &nbsp;

Matthew S. Davids, MD, MMSc, discusses the significance of the findings from TRANSCEND CLL 004, a phase I/II trial investigating the CAR T-cell therapy lisocabtagene maraleucel in patients with relapsed or refractory chronic lymphocytic leukemia.

Topline results from the ASCERTAIN trial of the&nbsp;cedazuridine and decitabine combination in patients with&nbsp;intermediate and high-risk myelodysplastic syndromes or chronic myelomoncyctis leukemia showed that the&nbsp;phase III trial met its primary endpoint. The fixed-dose combination demonstrated a&nbsp;decitabine exposure equivalence of total 5-day dosing compared with intravenous decitabine in the study patient population.&nbsp;

Polatuzumab vedotin in combination with&nbsp;bendamustine and rituximab has been granted an accelerated approval from the FDA for the&nbsp;treatment of patients with relapsed/refractory diffuse large B-cell lymphoma.<br /> &nbsp;

In an interview with <em>Targeted Oncology</em>, Naval G. Daver, MD, discussed the possibility of combination therapy in patients with AML. He highlights some of the most recent data to come out for this patient population, including for those harboring a <em>TP53</em> or <em>FLT3</em> mutation.

Jae H. Park, MD, discusses the current role and challenges in using CAR T-cell therapy in patients with relapsed or refractory acute myeloid leukemia. The 2 challenges now in this area are target selection and patient selection.

Patients with chronic lymphocytic leukemia showed high responses when given a combination of acalabrutinib and obinutuzumab, which targets BTK and the CD20 antigen. High response rates over 90% were seen across various settings of disease, according to the results of a small, preliminary trial.

The FDA has accepted a biologics license application for the investigational agent luspatercept for the treatment of adult patients with very low to intermediate-risk myelodysplastic syndromes&ndash;associated anemia who have ring sideroblasts and require red blood cell transfusions, and for the treatment of adult patients with beta-thalassemia&ndash;associated anemia who require RBC transfusions. In addition, a priority review designation was granted for the beta-thalassemia indication.<br /> &nbsp;

According to the pivotal phase III CLL14 study presented during the 2019 American Society of Clinical Oncology Annual Meeting, venetoclax plus obinutuzumab demonstrated a lengthening in progression-free survival time for patients with previously untreated chronic lymphocytic leukemia compared with obinutuzumab plus chlorambucil. Trial results show that the chemotherapy-free combination reduced the risk for disease worsening or death by 65% compared with obinutuzumab plus chlorambucil.

A look back at all the&nbsp;FDA news&nbsp;that happened in the month of&nbsp;May 2019, including several new approvals, orphan drug designations, breakthrough therapy designations, fast track designations, and more.

Copanlisib has been granted with a breakthrough therapy designation from the FDA for the&nbsp;treatment of adult patients with relapsed marginal zone lymphoma who have received at least 2 prior therapies.

A supplemental new drug application has been approved by the FDA&nbsp;to update the label for gilteritinib (Xospata) to include final analysis data from the phase III ADMIRAL trial, which demonstrated an improvement in overall survival with the FLT3 inhibitor compared with salvage chemotherapy in adult patients with relapsed/refractory <em>FLT3</em>-mutant AML.

John M. Burke, MD, reviews the treatment options he considers when treating a patient with chronic lymphocytic leukemia and the factors that sway his clinical decisions.

The R²&nbsp;regimen of lenalidomide (Revlimid) plus rituximab (Rituxan) has been approved by the FDA for the treatment of patients&nbsp;with previously treated follicular lymphoma and marginal zone lymphoma, based on findings from the&nbsp;phase III AUGMENT trial.

Chronic Myeloid Leukemia