HEMATOLOGY

Jeff Sharman, MD, discusses findings of the phase III GENUINE study, which explored the combination of ublituximab (TG-1101) and ibrutinib (Imbruvica) for patients with previously treated high-risk chronic lymphocytic leukemia (CLL).

A clinical hold has been placed on the phase III KEYNOTE-183 and KEYNOTE-185 pembrolizumab trials and the discontinuation of the lenalidomide/dexamethasone/pembrolizumab arm of the KEYNOTE-023 trial has been ordered by the FDA.

A look back at all the FDA news that happened in the month of June, including in multiple myeloma, hematology, sarcoma, and lung cancer.

ClearLLab multicolor reagents (T1, T2, B1, B2, M) has been approved by the FDA for the detection of chronic leukemia, acute leukemia, non-Hodgkin lymphoma, multiple myeloma, myelodysplastic syndrome, and myeloproliferative neoplasms.

Sundar Jagannath, MDDS, professor, Medicine, Hematology, and Medical Oncology, Mount Sinai Hospital, discusses a first in-human multicenter study of bb2121 anti-BCMA CAR T-cell therapy for relapsed/refractory multiple myeloma.

According to findings from a small phase I study, all patients with multiple myeloma showed a response following treatment with an active dose of bb2121, an investigational anti–B-cell maturation antigen chimeric antigen receptor T-cell construct.

Patients with newly-diagnosed multiple myeloma who did not elect to undergo stem cell transplant but remained on single agent ixazomib maintenance fared as well as those who received SCT.

The combination regimen of ibrutinib, fludarabine, cyclophosphamide, and obinutuzumab achieved a high rate of minimal residual disease-negative status in bone marrow as a first-line treatment in patients with <em>IGHV</em>-mutated chronic lymphocytic leukemia

Subcutaneous rituximab has been approved by the FDA for the treatment of adults with previously untreated and relapsed or refractory follicular lymphoma, previously untreated diffuse large B-cell lymphoma, and previously untreated and previously treated CLL.

The BTK inhibitor ibrutinib continued to demonstrate sustained progression-free survival and overall survival in chronic lymphocytic leukemia, regardless of patients&rsquo; high-risk cytogenetic status.

The combination of the anti-CD20 monoclonal antibody obinutuzumab and bendamustine induced high rates of complete response and minimal residual disease negativity with no unexpected safety signals as a first-line therapy for patients with chronic lymphocytic leukemia.

Ruben A. Mesa, MD, has been named director of the UT Health Cancer Center.

A supplemental biologics license application for the use of denosumab for the prevention of skeletal-related events in patients with multiple myeloma has been accepted by the FDA.

Daratumumab has been approved by the FDA for use in combination with pomalidomide and dexamethasone for patients with multiple myeloma who have received at least 2 prior therapies, including a proteasome inhibitor and lenalidomide.

Javier Pinilla-Ibarz, MD, PhD, associate member, Malignant Hematology and Immunology Program at the H. Lee Moffitt Cancer Center, discusses ongoing research with ibrutinib (Imbruvica) in chronic lymphocytic leukemia.&nbsp;

Andrzej Jakubowiak, MD, PhD, professor of Medicine, University of Chicago Medicine, discusses safety results from an open label, phase 1b trial &nbsp;exploring daratumumab (Darzalex) combined with carfilzomib (Kyprolis), lenalidomide (Revlimid), and dexamethasone in patients with newly diagnosed multiple myeloma.

Merck has announced that enrollment for the phase III KEYNOTE-183 and KEYNOTE-185 multiple myeloma trials has been postponed due to deaths in patients treated with pembrolizumab.

Complete marrow clearance of leukemic cells was achieved in 8 of 9 evaluable patients with heavily pretreated or genetically high-risk chronic lymphocytic leukemia who received concurrent treatment with CTL-119 cell therapy and ibrutinib, results of a pilot study showed.

In patients with newly diagnosed chronic myeloid leukemia (CML) in chronic phase, a 400-mg dose of bosutinib (Bosulif) was associated with higher rates of major molecular response (MMR) and complete cytogenetic response (CCyR) than imatinib (Gleevec).

Jan A. Burger, MD, PhD and&nbsp;Javier Pinilla-Ibarz, MD, PhD shed light on the field of CLL and the transformative role of ibrutinib.

An overview of emerging targeted therapies and immunotherapies in chronic lymphocytic leukemia.

Sagar Lonial, MD, professor and chair, Department of Hematology &amp; Medical Oncology, Emory University School of Medicine, chief medical officer, Winship Cancer Institute of Emory University, discusses recent advancements in the treatment paradigm for multiple myeloma.

An overview of the factors affecting prognosis and treatment in chronic lymphocytic leukemia.

Current treatment strategies for chronic lymphocytic leukemia (CLL).

<p>CLL is a malignancy characterized by the clonal proliferation and accumulation of small, mature-appearing CD5-positive B lymphocytes in the blood, bone marrow, and secondary lymphoid tissues.</p>

Ublituximab (TG-1101) in combination with ibrutinib (Imbruvica) met its primary endpoint of showing an improvement in objective response rate (ORR) compared with ibruitinib monotherapy in patients with previously treated high-risk chronic lymphocytic leukemia (CLL). In a presentation of findings from the phase III GENUINE trial during the 2017 ASCO Annual Meeting, data were reviewed demonstrating that the combination had an ORR of 78% in this patient population.&nbsp;

Lenalidomide consolidation therapy following induction with fludarabine and rituximab (Rituxan) was found to increase long-term survival over survival rates&nbsp;seen with FR or FR plus cyclophosphamide in an overall survival plateau that intrigued researchers when examined in&nbsp;patients with symptomatic, treatment-naive chronic lymphocytic leukemia without an 11q deletion.

The FDA has scheduled a public hearing of its&nbsp;Oncologic Drugs Advisory Committee (ODAC) to address a biologics license application (BLA) for tisagenlecleucel-T (CTL019) for patients aged 3 to 25 years with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL). The hearing is planned for July 12, 2017.

Eytan M. Stein, MD, internist, hematologic oncologist, Memorial Sloan Kettering Cancer Center, discusses the results of a phase I dose escalation and expansion study of enasidenib in mutant <em>IDH-2</em> relapsed or refractory acute myeloid leukemia (AML) during the 2017 ASCO Annual Meeting.

Jorge Cortes, MD, deputy chair of the Department of Leukemia, The University of Texas MD Anderson Cancer Center, discusses initial results from the BFORE trial, which is exploring bosutinib (Bosulif) versus imatinib (Gleevec) for newly diagnosed chronic myeloid leukemia.