Preview of ASH 2016: Top Expert-Selected Studies

John M. Burke, MD

Associate Chair
US Oncology Hematology Research Program
Rocky Mountain Cancer Centers
Aurora, Colorado


John M. Burke, MD, has disclosed that he has received consulting fees from Bayer, Celgene, Incyte, and Pfizer.


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Jeff P. Sharman, MD

Medical Director
Hematology Research
US Oncology Research
Eugene, Oregon


Jeff P. Sharman, MD, has disclosed that he has received consulting fees from AbbVie, Celgene, Genentech, Gilead, and Pharmacyclics, as well as contracted research from AbbVie, Acerta, Celgene, Genentech, Gilead, and Pharmacyclics.


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Released: December 1, 2016

Preview of ASH 2016: Top Expert-Selected Studies

Authors: John M. Burke, MD, and Jeff P. Sharman, MD

At ASH 2016, important results from many clinical trials are being reported. Below expert faculty members have highlighted some of the most anticipated studies. Data from these abstracts will soon be available as downloadable summary slidesets and as a part of CME-certified online activities where our experts will discuss the clinical implications of the data after the ASH annual meeting.

Lymphomas/CLL
John M. Burke, MD, and Jeff P. Sharman, MD, have identified 3 key studies for patients with lymphomas that they are anxious to see. In follicular lymphoma, there are potentially practice-changing primary results from the randomized phase III GALLIUM study that is comparing induction therapy with obinutuzumab plus chemotherapy vs rituximab plus chemotherapy followed by maintenance therapy with the respective monoclonal antibodies in responding patients. In DLBCL, results will be shown from a randomized phase III study comparing R-CHOP vs DA-EPOCH-R in previously untreated patients. In addition, a late-breaking abstract will present exciting findings from the ZUMA-1 trial with anti-CD19 CAR T-cell therapy in patients with refractory DLBCL, a patient population in need of better treatment options.

Leukemias
Elias Jabbour, MD, and Farhad Ravandi, MD, have selected some of the most clinically relevant abstracts that they anticipate at the 2016 ASH conference. In AML, the cell-surface antigen CD33 is proving to be a promising therapuetic target, and the CD33 antibody–drug conjugate vadastuximab tailirine is the focus of numerous studies, including in combination with the 7+3 regimen or hypomethylating agents. In addition, results from studies of other regimens including other promising agents such as vorinostat (phase III SWOG S1203) and venetoclax will be presented. An analysis of patients with ALL treated with blinatumomab in the phase III TOWER trial suggests improved quality of life vs standard of care, and researchers will present preliminary findings from a global registration trial of the CTL019 CAR T-cell therapy in pediatric and young adult patients with ALL. In CML, researchers will present results from the Euro-Ski trial examining the impact of TKI cessation in patients with deep molecular response.

Myelodysplastic Syndromes and Myeloproliferative Neoplasms
Rami S. Komrokji, MD and Jamile Shammo, MD, FASCP, FACP, have chosen abstracts with exciting findings that will likely affect clinical practice in all stages of treatment for patients with MDS and MPNs. In patients with low-risk MDS, the addition of epoetin alfa to lenalidomide in the frontline setting has demonstrated superiority in the ECOG-ACRIN E2905 Intergroup study and an MDS Clinical Research Consortium study comparing the safety and efficacy of low-dose decitabine with low-dose azacitidine will be presented. In patients with relapse following HMAs, novel TLR-2 antibody is showing promise in low-risk populations. The novel IDH2 inhibitor enasidenib (AG-221) has also induced hematologic responses in patients following relapse. In addition, the immune checkpoint inhibitors nivolumab and ipilimumab are also demonstrating responses in MDS, used in combination with azacitidine. Several studies investigating new therapeutic approaches to the treatment of MPNs will also be presented, including the results of 2 anticipated phase III trials: the PROUD-PV study comparing ropeginterferon alfa-2b to hydroxyurea in patients with polycythemia vera and the MPD-RC 112 trial exploring frontline peginterferon alfa-2a vs hydroxyurea in patients with polycythemia vera and essential thrombocythemia. For patients with myelofibrosis, there are exciting data about the combination of ruxolitinib in combination with 5-azacytidine and the novel ActRIIA ligand trap sotatercept.

Multiple Myeloma
Shaji Kumar, MD, and Sagar Lonial, MD, selected a group of 4 abstracts with new information for clinicians who treat patients with MM, including data on 2 new agents, 1 new formulation, and new data affecting clinical practice regarding transplantations. The first study selected is a late-breaking abstract this year and explores the best approach for transplantation in eligible patients with symptomatic MM. The phase III StaMINA trial enrolled patients within 12 months of receiving induction therapy who had not progressed and randomized participants (N = 758) to receive either ASCT followed by 4 cycles of RVd consolidation, tandem ASCT, or single ASCT and each treatment arm also received lenalidomide maintenance. Daratumumab was approved as a single agent in 2015 and recently in combination with either Rd or Vd. At ASH 2016, data from the PAVO trial show promising safety, pharmacokinetics, and efficacy of subcutaneous, instead of IV, administration of daratumumab with rHuPH20 to facilitate absorption. The rapid pace of discovery for MM seems to be continuing with promising data from the phase II STORM trial evaluating selinexor, an oral selective XPO1 inhibitor, with dexamethasone in patients with “quad”- or “penta”-refractory MM. Promising data from a phase I trial with the BCL-2 inhibitor venetoclax (currently approved in CLL) suggest that single-agent venetoclax may be an option for patients with relapsed/refractory MM, particularly for patients with t(11;14) translocations.

These are just a few of the interesting and important abstracts selected by our expert faculty from the 2016 ASH annual meeting. We will have slideset summaries of these and other data available on our Web site as the data are presented, and comprehensive analyses by our expert faculty members will explore the clinical implications of the data in CME-certified text modules following the meeting.

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