The Lynx Group

ASH

Orlando, FL—The emergence of cellular immunotherapy for a broad array of hematologic malignancies was featured prominently at ASH 2019. The development of adoptive therapy with T-cells that target oncologic malignancies was the subject of the E. Donnall Thomas Lecture “The Long Road to Develop Adoptive Therapy with T Cells That Can Effectively Target Acute Myeloid Leukemia (AML) and Other Malignancies,” delivered by Philip Greenberg, MD, Head, Program in Immunology, Fred Hutchinson Cancer Research Center, Seattle, WA.
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Results from TRANSCEND CLL 004 showed chimeric antigen receptor (CAR) T-cell treatment with lisocabtagene maraleucel in heavily pretreated patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who had failed ibrutinib was manageable and produced durable undetectable minimal residual disease responses.
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Results from the 3-year update of the phase 2 AIM trial confirmed the effectiveness of ibrutinib + venetoclax therapy for patients with mantle-cell lymphoma, and indicated that treatment interruption was feasible for patients in minimal residual disease–negative complete remissions.
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A large observational study showed increased first-line bendamustine-rituximab use among older patients with splenic or nodal marginal zone lymphoma was not associated with significant event-free survival or overall survival benefit versus single-agent rituximab, but led to increased toxicities and costs.
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Updated results from a phase 1/2 trial indicate that acalabrutinib monotherapy was associated with a favorable safety profile and showed antileukemic activity in patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma, irrespective of high-risk genomic features.
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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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