A phase I/II study presented at the 51st Annual Meeting of the American Society of Hematology in New Orleans, Louisiana, found that INCB018424, an experimental JAK2 inhibitor, demonstrated activity in patients with myelofibrosis. INCB018424 shrank enlarged spleens, helped patients gain weight, reduced pain, and increased patients’ capacity to exercise, all of which significantly improved their quality of life.

Bendamustine (Treanda) plus rituximab (Rituxan; B/R) was superior to CHOP plus rituximab (CHOP-R) as first-line therapy of indolent lymphoma and mantle cell lymphoma in a multicenter, randomized, controlled trial of the German Study Group on Indolent Lymphoma (StiL). At an oral presentation at the 51^st ASH Annual Meeting, experts agreed that this study may be practice-changing.

New Orleans, LA - Although studies have shown plerixafor (Mozobil) plus granulocyte-colony stimulating factor (G-CSF) mobilizes more CD34+ cells than G-CSF alone prior to autologous hematopoietic stem cell transplant, many patients receive chemotherapy followed by G-CSF to mobilize CD34+ cells before transplantation. In a poster session presented at the 51st ASH Annual Meeting, Paul J. Shaughnessy, MD, medical director, Adult Blood and Marrow Transplant, Texas Transplant Institute, San Antonio, Texas, reported the results of a retrospective study that found plerixafor plus G-CSF mobilization resulted in more predictable days of collection, no weekend apheresis procedures, and no unscheduled hospital admissions compared with chemotherapy plus G-CSF.

A study being presented at the 51^st ASH Annual Meeting, however, has found that patients with hematologic malignancies who participate in advanced care planning are no more likely to have psychosocial problems than their counterparts who lack an advanced care plan.

Omacetaxine (Omapro) achieved durable hematologic and cytogenetic responses in patients with chronic myeloid leukemia (CML) who failed treatment with imatinib (Gleevec). All patients in this phase II/III study had developed the T3151 mutation, which confers resistance to imatinib and to the second-generation tyrosine kinase inhibitors (TKIs) nilotinib (Tasigna) and dasatinib (Sprycel).

Researchers at ASH presented data that showed patients with diffuse large B-cell lymphoma (DLBCL) who had deficient vitamin D levels—defined as serum 25-hydroxyvitamin (25-OH-VitD) <25 ng/mL—had poorer outcomes than patients with normal vitamin D levels. Vitamin D deficiency was independently associated with a 1.5-fold greater risk of disease progression and twice the risk of death.

There has been a paucity of information on the initial clinical treatment of patients with multiple myeloma and the psychosocial variables that affect their care in community-based practices. To address this issue, Neil Love, MD, Research to Practice, Miami, Florida, and colleagues developed a Web-based tool to rapidly gather reliable, multidimensional information on patients with newly diagnosed multiple myeloma.

Lenalidomide (Revlimid) has promising anti-tumor activity in aggressive B-cell non-Hodgkin lymphoma (NHL), with a predictable toxicity profile. Results of an international phase II study suggest that lenalidomide should be studied in combination with other regimens in the treatment of the various subtypes of aggressive NHL, including diffuse large B-cell lymphoma (DLBCL), transformed lymphoma, follicular grade III lymphoma, and mantle cell lymphoma (MCL), according to Thomas E. Witzig, MD, Mayo Clinic College of Medicine, Rochester, MN, who presented results of this study at the 51^st ASH Annual Meeting.

Single-agent pixantrone, an investigational agent, showed encouraging third-line responses, duration of responses, and progression-free survival (PFS) compared with other single-agent chemotherapies in patients with relapsed aggressive non-Hodgkin lymphoma (NHL) in the phase III, randomized, open-label, multicenter EXTEND trial. In the study, patients with relapsed/refractory NHL treated with pixantrone achieved significant increases in complete response (CR) and overall response (ORR) and demonstrated a positive trend in overall survival (OS) compared with other chemotherapy agents, according to Ruth Pettengell, MD, of St. Georges Hospital in London, who presented these results at a poster session. “An anthracycline with reduced cardiotoxicity that can be used for salvage therapy of aggressive NHL meets a significant unmet medical need,” she said.

In a plenary session at the 51^st ASH Annual Meeting, data from a randomized trial in elderly patients with multiple myeloma (MM) showed combining bortezomib (Velcade) and prednisone with the alkylating agent melphalan (VMP) is safer than adding thalidomide (VTP), an immunomodulatory drug, and just as effective. Maria-Victoria Mateos, MD, PhD, attending physician in hematology at Hospital Universitario de Salamanca in Spain, presented the results from the two-stage phase III trial conducted by the Spanish Myeloma Group.

Romiplostim is a peptibody protein that increases platelet production by binding to and activating the thrombopoietin receptor. Patients with MDS frequently develop clinically significant thrombocytopenia (CST) or other bleeding problems for which transfusion has long been the only available treatment. Three studies presented at ASH suggest that romiplostim might be a safe, effective method for increasing platelet counts in MDS patients and that further trials are warranted.

Cancer patients are at high risk for venous thromboembolism (VTE), a leading cause of death in patients with cancer. Fixed-dose dabigatran may be a replacement for warfarin in the treatment of VTE, according to results of the large Phase III RE-COVER trial.

Treatment with 8 cycles of CHOEP-R (cyclophosphamide, vincristine, doxorubicin, prednisone, etoposide, rituximab)-14 achieved excellent interim results in young, high-risk patients with previously untreated aggressive B-cell lymphoma, while the comparator arm of intensified CHOEP-R-21 followed by autologous stem cell transplant (“MegaCHOEP-R) was inferior and had greater toxicity.

A combination of fludarabine and alemtuzumab (FluCam) was shown to improve outcomes for patients with relapsed or refractory chronic lymphocytic leukemia (CLL) in a single-arm pilot study and in a phase II trial. To validate these observations and assess the efficacy and safety of FluCam versus fludarabine monotherapy as second-line therapy for patients with relapsed or refractory CLL, researchers conducted a phase III, multicenter, open-label, randomized trial, the results of which were released at the 51st ASH Annual Meeting.

Bexxar (tositumomab and iodine I 131) pairs the targeting ability of a monoclonal antibody and the therapeutic potential of radiation to form a radiolabeled monoclonal antibody regimen able to bind to the target antigen 20 found on normal and cancerous B cells. According to a poster presented by Mark S. Kaminski, MD, University of Michigan, Ann Arbor, at the 51st ASH Annual Meeting, 83% of patients with treatment-naïve follicular lymphoma who received Bexxar experienced overall survival of 10 years.

Several studies have been examining various 3- and even 4-drug regimens in patients with newly diagnosed multiple myeloma. Paul G. Richardson, MD, and colleagues from the Dana-Farber Cancer Institute in Boston, Massachusetts, conducted a phase I/II study investigated the novel combination of lenalidomide (Revlimid), bortezomib (Velcade), and dexamethasone (Decadron). In an interview with Oncology & Biotech News/Oncology NetGuide, Dr Richardson said response was “unprecedented.” In presenting data from the studies, Dr Richardson said, “Partial responses or better were seen in all of the 66 patients treated with the drug combination…with 74% having a VGPR rate in the phase II portion.” He added that the 54% rate of CR/near CR in patients enrolled in the phase II study “was also encouraging.”

Even though imatinib (Gleevec) is a highly effective drug for chronic myeloid leukemia (CML) and the standard of care for newly diagnosed patients, a phase III study presented at a late-breaking news session showed that nilotinib (Tasigna) was superior as first-line therapy. This conclusion was based on rates of molecular and cytogenetic response. 

A multi-target kinase inhibitor, known as AP24534, has shown strong clinical evidence of hematologic, cytogenetic, and molecular anti-cancer activity in heavily pretreated patients with resistant and refractory chronic myeloid leukemia (CML), including in those with the T315I mutation of the target protein, BCR-ABL.

During the 51st ASH Annual Meeting, several new data from the PROPEL trial were released, including updates on the ORR and safety of pralatrexate in patients with PTCL and data on the correlation between baseline methylmalonic acid status and mucositis severity in this population. While the data reinforce pralatrexate as a viable treatment in patients with relapsed or refractory PTCL, some question whether the drug confers enough of a benefit to warrant its $30,000 per month cost.  
  

Current treatments for chronic lymphocytic leukemia (CLL) can be damaging to the immune system, leaving patients vulnerable to infections, which is the primary cause of death for many patients with CLL. According to a study presented at the 51st Annual American Society of Hematology Meeting, a new oral agent called 17-DMAG may avoid this problem. 

Mouse models assessing 17-DMAG showed this agent to be highly selective for CLL cells, while having minimal effect on normal immune cells, suggesting the agent leaves the immune system intact.

Data from the fully enrolled REVEAL-1 trial presented at the 51st ASH Annual Meeting showed single-agent voreloxin, an investigational drug, to be a safe and effective treatment in elderly patients with treatment-naïve acute myeloid leukemia (AML).