ASH 2017


Enasidenib and ivosidenib monotherapy have demonstrated induction of clinical responses in patients with mutant IDH (mIDH) relapsed/refractory acute myeloid leukemia (AML), whereas azacitidine (AZA) monotherapy prolongs survival in older patients with the newly diagnosed (ND) AML. Based on these results and coupled with preclinical evidence of synergy with combination of mIDH inhibitors plus AZA, an ongoing phase 1b/2 study evaluated the efficacy and safety of this combination in ND AML; results of the phase 1b portion were reported at ASH 2017.
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Midostaurin, a multikinase inhibitor targeting FLT3 and KIT, is indicated for the treatment of patients with newly diagnosed, FLT3 mutation–positive acute myeloid leukemia (AML) in combination with standard induction and consolidation chemotherapy, based on demonstrations of superior survival outcomes versus placebo in the randomized, double-blind, phase 3 RATIFY trial. The Radius-X open-label expanded treatment protocol (ETP) was designed to provide access to midostaurin and obtain additional insights into the safety and tolerability profile of midostaurin in adult patients with newly diagnosed, FLT3 mutation–positive AML.
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Enasidenib (AG-221) is a novel, small-molecule oral inhibitor of mutated IDH2 (mIDH2) proteins that is currently indicated for the treatment of adult patients with mIDH-positive relapsed or refractory (R/R) acute myeloid leukemia (AML). The phase 1 AG221-C-001 study demonstrated the clinical efficacy of enasidenib in patients with mIDH2 R/R AML. Given the limited treatment options for older patients with untreated AML, the current analysis sought to evaluate the clinical outcomes for older patients with previously untreated mIDH2 AML who received enasidenib monotherapy in the AG221-C-001 study.
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Available preclinical and clinical evidence suggests that inhibition of PD-1/PD-L1 pathways increases antileukemic responses in acute myeloid leukemia (AML). Moreover, azacitidine treatment results in upregulation of PD-1 signaling, which is associated with azacitidine resistance. Based on this rationale, the current study evaluated the safety and efficacy of combination nivolumab plus azacitidine treatment in 2 patient cohorts: those with relapsed or refractory (R/R) AML with poor-risk features, and in elderly patients with untreated AML.
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Atlanta, GA—A maintenance regimen of lenalidomide (Revlimid) and elotuzumab (Empliciti) after autologous stem-cell transplant (ASCT) improved the quality of responses achieved with induction therapy in patients with multiple myeloma.
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Atlanta, GA—A pair of recent studies from the Mayo Clinic underscore the serious symptom burden experienced by patients diagnosed with myeloproliferative neoplasms (MPNs), according to data presented at ASH 2017. Specifically, patients with MPNs are at high risk for depression, and those with Philadelphia chromosome–negative disease are afflicted with sleep and psychiatric disturbance as well.
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The combination of fludarabine, cyclophosphamide, and rituximab (FCR) has been the standard first-line treatment for young patients with chronic lymphocytic leukemia (CLL), with a complete remission (CR) rate after 6 cycles of 40% to 72%, and an undetectable bone marrow (BM) minimal residual disease (MRD) rate after 6 cycles of 43% to 58%.
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In patients with mantle-cell lymphoma (MCL), adverse events (AEs) can impair patient adherence to planned therapeutic regimens, and moderate-to-severe AEs generally require medical attention and are often associated with increased healthcare resource use (HRU) and costs. At ASH 2017, the authors presented the results of a retrospective cohort analysis designed to assess HRU and direct costs of MCL, examine variation in costs across treatment types, and document the economic burden associated with MCL treatment-related AEs.
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Ibrutinib (ibr) is a first-in-class oral inhibitor of Bruton’s tyrosine kinase approved for relapsed/refractory (R/R) mantle-cell lymphoma (MCL). The results of a pooled analysis of 370 patients with R/R MCL treated with ibr in the SPARK, RAY, and PCYC-1104 studies were previously reported (median follow-up, 24 months). At ASH 2017, the authors presented median 3.5-year follow-up in these patients, including additional exposure and follow-up of 87 patients across the 3 studies who enrolled in the long-term access study, CAN3001.
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