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1. Topic: AS08-Treatment/AS08b-Current treatment options – Lower risk MDS: PHASE 1 STUDY EVALUATING LOW-DOSE (LD) ORAL DECITABINE/CEDAZURIDINE (ASTX727) IN LOWER-RISK MYELODYSPLASTIC SYNDROMES (LR-MDS) PATIENTS

Author

Garcia-Manero, G., primary, Bachiashvili, K., additional, Amin, H., additional, Traer, E., additional, Pollyea, D., additional, Sallman, D., additional, Al-Kali, A., additional, Cripe, L., additional, Berdeja, J., additional, Griffiths, E., additional, Mohan, S., additional, Vachhani, P., additional, Sano, Y., additional, Oganesian, A., additional, Keer, H., additional, and Yacoub, A., additional

Published
2023
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2. Topic: AS08-Treatment/AS08f-Clinical trials – Phase II-III: RANDOMIZED PHASE 2 STUDY TO ASSESS SAFETY AND EFFICACY OF LOW-DOSE (LD) ORAL DECITABINE/CEDAZURIDINE (ASTX727) IN LOWER-RISK MYELODYSPLASTIC SYNDROMES (LR-MDS) PATIENTS: INTERIM SAFETY ANALYSIS

Author

Garcia-Manero, G., primary, Bachiashvili, K., additional, Griffiths, E., additional, Traer, E., additional, Saini, L., additional, Amin, H., additional, Zeidan, A., additional, Mohan, S., additional, Lübbert, M., additional, Maness, L., additional, Foran, J., additional, Selleslag, D., additional, Xicoy, B., additional, Pollyea, D., additional, Sallman, D., additional, Al-Kali, A., additional, Berdeja, J., additional, Al-Ali, H., additional, Zhu, N., additional, Lopez, P. Font, additional, Sanz, G., additional, Santini, V., additional, Yimer, H., additional, Cripe, L., additional, Priego, V., additional, Odenike, O., additional, Heyrman, B., additional, Valcárcel, D., additional, Vachhani, P., additional, Sano, Y., additional, Mirakhur, B., additional, Oganesian, A., additional, Keer, H., additional, and Yacoub, A., additional

Published
2023
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3. P135 - Topic: AS08-Treatment/AS08f-Clinical trials – Phase II-III: RANDOMIZED PHASE 2 STUDY TO ASSESS SAFETY AND EFFICACY OF LOW-DOSE (LD) ORAL DECITABINE/CEDAZURIDINE (ASTX727) IN LOWER-RISK MYELODYSPLASTIC SYNDROMES (LR-MDS) PATIENTS: INTERIM SAFETY ANALYSIS

Author

Garcia-Manero, G., Bachiashvili, K., Griffiths, E., Traer, E., Saini, L., Amin, H., Zeidan, A., Mohan, S., Lübbert, M., Maness, L., Foran, J., Selleslag, D., Xicoy, B., Pollyea, D., Sallman, D., Al-Kali, A., Berdeja, J., Al-Ali, H., Zhu, N., Lopez, P. Font, Sanz, G., Santini, V., Yimer, H., Cripe, L., Priego, V., Odenike, O., Heyrman, B., Valcárcel, D., Vachhani, P., Sano, Y., Mirakhur, B., Oganesian, A., Keer, H., and Yacoub, A.

Published
2023
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7. P519: TRANSFUSION INDEPENDENCE AMONG NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA PATIENTS RECEIVING VENETOCLAX-BASED COMBINATIONS VS OTHER THERAPIES: RESULTS FROM THE AML REAL WORLD EVIDENCE (ARC) INITIATIVE

Author

Wolach, O., primary, Garcia, J. S., additional, Vachhani, P., additional, Zeidner, J., additional, Lai, C., additional, Moshe, Y., additional, Xavier, M., additional, Lee, S., additional, Zuckerman, T., additional, Pollyea, D. A., additional, Abedin, S., additional, Chen, E. C., additional, Bathini, S., additional, Edwards, W., additional, Bui, C. N., additional, Cheng, W. W.-H., additional, Svensson, A., additional, Guérin, A., additional, Maitland, J., additional, Ma, E., additional, Montez, M., additional, Grunspan, M., additional, and Goldberg, A. D., additional

Published
2022
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8. P584: OVERALL SURVIVAL WITH INTENSIVE CHEMOTHERAPY (IC) VS NON-IC IN PATIENTS (PTS) WITH NEWLY DIAGNOSED (ND) AML FROM THE CONNECT® MYELOID DISEASE REGISTRY INELIGIBLE FOR RANDOMIZED CLINICAL TRIALS (RCT)

Author

Erba, H., primary, Pollyea, D., additional, Sekeres, M., additional, Garcia-Manero, G., additional, Seiter, K., additional, DeGutis, I., additional, Kiselev, P., additional, McBride, A., additional, Yu, E., additional, and Roboz, G., additional

Published
2022
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9. S166: MAGROLIMAB IN COMBINATION WITH AZACITIDINE FOR PATIENTS WITH UNTREATED HIGHER-RISK MYELODYSPLASTIC SYNDROMES (HR MDS): 5F9005 PHASE 1B STUDY RESULTS

Author

Sallman, D. A., primary, Al Malki, M. M., additional, Asch, A. S., additional, Wang, E. S., additional, Jurcic, J. G., additional, Bradley, T. J., additional, Flinn, I. W., additional, Pollyea, D. A., additional, Kambhampati, S. N., additional, Tanaka, T. N., additional, Zeidner, J. F., additional, Garcia-Manero, G., additional, Jeyakumar, D., additional, Gu, L., additional, Tan, A., additional, Chao, M., additional, O’Hear, C., additional, Lal, I., additional, Vyas, P., additional, and Daver, N., additional

Published
2022
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11. P492: TAMIBAROTENE IN COMBINATION WITH VENETOCLAX AND AZACITIDINE IN PREVIOUSLY UNTREATED ADULT PATIENTS SELECTED FOR RARA-POSITIVE AML WHO ARE INELIGIBLE FOR STANDARD INDUCTION THERAPY (SELECT AML-1)

Author

Stein, E., primary, de Botton, S., additional, Pigneux, A., additional, McMahon, C., additional, Ball, B., additional, Borthakur, G., additional, Eghtedar, A., additional, Kambhampati, S., additional, Tache, J., additional, Wang, E., additional, Kelley, H., additional, Volkert, A., additional, Baker, K., additional, Kang-Fortner, Q., additional, Hodgson, G., additional, Madigan, C., additional, Warlick, E., additional, Roth, D., additional, Kelly, M., additional, and Pollyea, D., additional

Published
2022
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19. S878 THE FIRST-IN-CLASS ANTI-CD47 ANTIBODY HU5F9-G4 IS ACTIVE AND WELL TOLERATED ALONE OR IN COMBINATION WITH AZACITIDINE IN AML AND MDS PATIENTS: INITIAL PHASE 1B RESULTS

Author

Sallman, D., primary, Donnellan, W., additional, Asch, A., additional, Lee, D., additional, Al Malki, M., additional, Pollyea, D., additional, Kambhampati, S., additional, Komrokji, R., additional, Van Elk, J., additional, Lin, M., additional, Agoram, B., additional, Chen, J., additional, Volkmer, J., additional, Takimoto, C., additional, Chao, M., additional, and Vyas, P., additional

Published
2019
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21. 249 CONNECT MDS AND AML: THE MYELODYSPLASTIC SYNDROMES (MDS) AND ACUTE MYELOID LEUKEMIA (AML) DISEASE REGISTRY

Author

Steensma, D., primary, Abedi, M., additional, Bejar, R., additional, Cogle, C., additional, Foucar, K., additional, Garcia-Manero, G., additional, George, T., additional, Grinblatt, D., additional, Komrokji, R., additional, Maciejewski, J., additional, Pollyea, D., additional, Roboz, G., additional, Savona, M., additional, Scott, B., additional, Sekeres, M., additional, Thompson, M., additional, Sugrue, M., additional, Swern, A., additional, Nifenecker, M., additional, and Erba, H., additional

Published
2015
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24. Poster session 6. Phase 1 studies

Author

Pollyea, D., primary, Gore, L., additional, Gutman, J., additional, Eckhardt, S. G., additional, Hagelstrom, N., additional, Coutre, S., additional, Thirman, M., additional, Byrd, J., additional, Massimini, G., additional, Laffranchi, B., additional, Rejeb, N., additional, Asatiani, E., additional, Milner, A., additional, von Richter, O., additional, Locatelli, G., additional, Ogden, J. A., additional, Osterwalder, B., additional, Meng, R., additional, Molife, L. R., additional, de Mattos-Arruda, L., additional, Hollebecque, A., additional, Isakoff, S. J., additional, Roda, D., additional, Yan, Y., additional, Cervantes, A., additional, Soria, J. C., additional, Mateo, J., additional, Argiles, G., additional, Bendell, J. C., additional, El-Khoueiry, A., additional, Jonker, D. J., additional, Sawyer, M. B., additional, Wong, L., additional, Becerra, C. R., additional, Chemidlin, J. M., additional, Kollia, G., additional, Nuyten, D. S. A., additional, Twelves, C. J., additional, Wilkins, D. K., additional, Anthoney, A., additional, Chappell, J., additional, Ng, W. T., additional, Turner, P. T., additional, Kristeleit, R., additional, Schoenborn-Kellenberger, O., additional, and Suder, A., additional

Published
2013
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25. Sequential azacitidine plus lenalidomide combination for elderly patients with untreated acute myeloid leukemia

Author

Pollyea, D. A., primary, Zehnder, J., additional, Coutre, S., additional, Gotlib, J. R., additional, Gallegos, L., additional, Abdel-Wahab, O., additional, Greenberg, P., additional, Zhang, B., additional, Liedtke, M., additional, Berube, C., additional, Levine, R., additional, Mitchell, B. S., additional, and Medeiros, B. C., additional

Published
2012
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26. Safety, efficacy and biological predictors of response to sequential azacitidine and lenalidomide for elderly patients with acute myeloid leukemia

Author

Pollyea, D A, primary, Kohrt, H E, additional, Gallegos, L, additional, Figueroa, M E, additional, Abdel-Wahab, O, additional, Zhang, B, additional, Bhattacharya, S, additional, Zehnder, J, additional, Liedtke, M, additional, Gotlib, J R, additional, Coutre, S, additional, Berube, C, additional, Melnick, A, additional, Levine, R, additional, Mitchell, B S, additional, and Medeiros, B C, additional

Published
2011
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27. Sequential azacitidine and lenalidomide in elderly acute myeloid leukemia: completed results of the phase I study.

Author

Pollyea, D. A., primary, Kohrt, H. E., additional, Gallegos, L., additional, Zhang, B., additional, Figueroa, M., additional, Melnick, A., additional, Berube, C., additional, Coutre, S. E., additional, Gotlib, J. R., additional, Zehnder, J. L., additional, Liedtke, M., additional, Mitchell, B. S., additional, and Medeiros, B. C., additional

Published
2011
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33. Durable Remissions with Ivosidenib in IDH1-Mutated Relapsed or Refractory AML.

Author

DiNardo, C. D., Stein, E. M., de Botton, S., Roboz, G. J., Altman, J. K., Mims, A. S., Swords, R., Collins, R. H., Mannis, G. N., Pollyea, D. A., Donnellan, W., Fathi, A. T., Pigneux, A., Erba, H. P., Prince, G. T., Stein, A. S., Uy, G. L., Foran, J. M., Traer, E., and Stuart, R. K.

Subjects
*GENETIC mutation, *ISOCITRATE dehydrogenase, *ACUTE myeloid leukemia, *SMALL molecules, *DRUG dosage, *DRUG efficacy, *DISEASE remission, *CANCER relapse, *CLINICAL trials, *COMPARATIVE studies, *DRUG resistance in cancer cells, *DOSE-effect relationship in pharmacology, *ENZYME inhibitors, *HEMOGLOBINS, *LONGITUDINAL method, *RESEARCH methodology, *MEDICAL cooperation, *ORAL drug administration, *OXIDOREDUCTASES, *RESEARCH, *SURVIVAL, *DISEASE relapse, *CYTOMETRY, *EVALUATION research, *CHEMICAL inhibitors
Abstract

Background: Mutations in the gene encoding isocitrate dehydrogenase 1 ( IDH1) occur in 6 to 10% of patients with acute myeloid leukemia (AML). Ivosidenib (AG-120) is an oral, targeted, small-molecule inhibitor of mutant IDH1.Methods: We conducted a phase 1 dose-escalation and dose-expansion study of ivosidenib monotherapy in IDH1-mutated AML. Safety and efficacy were assessed in all treated patients. The primary efficacy population included patients with relapsed or refractory AML receiving 500 mg of ivosidenib daily with at least 6 months of follow-up.Results: Overall, 258 patients received ivosidenib and had safety outcomes assessed. Among patients with relapsed or refractory AML (179 patients), treatment-related adverse events of grade 3 or higher that occurred in at least 3 patients were prolongation of the QT interval (in 7.8% of the patients), the IDH differentiation syndrome (in 3.9%), anemia (in 2.2%), thrombocytopenia or a decrease in the platelet count (in 3.4%), and leukocytosis (in 1.7%). In the primary efficacy population (125 patients), the rate of complete remission or complete remission with partial hematologic recovery was 30.4% (95% confidence interval [CI], 22.5 to 39.3), the rate of complete remission was 21.6% (95% CI, 14.7 to 29.8), and the overall response rate was 41.6% (95% CI, 32.9 to 50.8). The median durations of these responses were 8.2 months (95% CI, 5.5 to 12.0), 9.3 months (95% CI, 5.6 to 18.3), and 6.5 months (95% CI, 4.6 to 9.3), respectively. Transfusion independence was attained in 29 of 84 patients (35%), and patients who had a response had fewer infections and febrile neutropenia episodes than those who did not have a response. Among 34 patients who had a complete remission or complete remission with partial hematologic recovery, 7 (21%) had no residual detectable IDH1 mutations on digital polymerase-chain-reaction assay. No preexisting co-occurring single gene mutation predicted clinical response or resistance to treatment.Conclusions: In patients with advanced IDH1-mutated relapsed or refractory AML, ivosidenib at a dose of 500 mg daily was associated with a low frequency of grade 3 or higher treatment-related adverse events and with transfusion independence, durable remissions, and molecular remissions in some patients with complete remission. (Funded by Agios Pharmaceuticals; ClinicalTrials.gov number, NCT02074839 .). [ABSTRACT FROM AUTHOR]

Published
2018
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34. Perspective: Pivotal translational hematology and therapeutic insights in chronic myeloid hematopoietic stem cell malignancies.

Author

Mughal TI, Pemmaraju N, Bejar R, Gale RP, Bose P, Kiladjian JJ, Prchal J, Royston D, Pollyea D, Valent P, Brümmendorf TH, Skorski T, Patnaik M, Santini V, Fenaux P, Kucine N, Verstovsek S, Mesa R, Barbui T, Saglio G, and Van Etten RA

Subjects
Hematopoietic Stem Cells, Humans, COVID-19, Graft vs Host Disease, Hematology, Myeloproliferative Disorders drug therapy
Abstract

Despite much of the past 2 years being engulfed by the devastating consequences of the SAR-CoV-2 pandemic, significant progress, even breathtaking, occurred in the field of chronic myeloid malignancies. Some of this was show-cased at the 15th Post-American Society of Hematology (ASH) and the 25th John Goldman workshops on myeloproliferative neoplasms (MPN) held on 9th-10th December 2020 and 7th-10th October 2021, respectively. The inaugural Post-ASH MPN workshop was set out in 2006 by John Goldman (deceased) and Tariq Mughal to answer emerging translational hematology and therapeutics of patients with these malignancies. Rather than present a resume of the discussions, this perspective focuses on some of the pivotal translational hematology and therapeutic insights in these diseases., (© 2022 John Wiley & Sons Ltd.)

Published
2022
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35. Enasidenib for the treatment of acute myeloid leukemia.

Author

Dugan J and Pollyea D

Subjects
Adult, Aminopyridines adverse effects, Aminopyridines pharmacology, Antineoplastic Agents adverse effects, Antineoplastic Agents pharmacology, Humans, Isocitrate Dehydrogenase genetics, Leukemia, Myeloid, Acute genetics, Leukemia, Myeloid, Acute pathology, Mutation, Triazines adverse effects, Triazines pharmacology, Aminopyridines therapeutic use, Antineoplastic Agents therapeutic use, Leukemia, Myeloid, Acute drug therapy, Triazines therapeutic use
Abstract

Introduction: In August 2017, the United States Federal Drug Administration (FDA) approved enasidenib (Idhifa, Celgene/Agios) for adults with relapsed and refractory acute myelogenous leukemia (AML) with an IDH2 mutation. Enasidenib targets cells with mutant copies of isocitrate dehydrogenase-2 (IDH2), inhibiting the oncometabolite 2-hydroxyglutarte (2-HG) formed by the mutant IDH2. Areas covered: We review the studies leading to enasidenib's approval, as well as common side effects and safety issues experienced during the clinical trials. There is a focus on the diagnosis and treatment of these side effects including differentiation syndrome. Expert commentary: We are experiencing a revolution in the understanding of the mechanism of AML. A majority of the effort has been concentrated on targeting gene mutations or pathway activations with precision therapeutics. Enasidenib is beneficial in a patient population that previously had limited treatment options. However, given the fact that enasidenib is a highly specific inhibitor of an early stable mutation, it is questionable whether a strategy of targeting a single mutation or pathway in relapsed AML will allow for better than the 20% complete remission (CR) rate observed with this therapy. The proper role for single mutation targeting in AML needs to be carefully considered.

Published
2018
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36. Omacetaxine mepesuccinate for the treatment of chronic myeloid leukemia.

Author

Narayanan V, Gutman JA, Pollyea DA, and Jimeno A

Subjects
Clinical Trials as Topic, Drug Interactions, Harringtonines adverse effects, Harringtonines pharmacology, Homoharringtonine, Humans, Harringtonines therapeutic use, Leukemia, Myelogenous, Chronic, BCR-ABL Positive drug therapy
Abstract

Omacetaxine mepesuccinate is a protein synthesis inhibitor that causes apoptosis of chronic myeloid leukemia cells without binding to the BCR-ABL tyrosine kinase that is implicated in the pathogenesis of this disease. It has been approved for the treatment of chronic myeloid leukemia in patients with resistance to two or more tyrosine kinase inhibitors and is emerging as an important agent in countering the highly resistant T315I mutation. This review will focus on the preclinical pharmacology, pharmacokinetics and clinical utility of omacetaxine mepesuccinate in the current milieu of tyrosine kinase inhibitor-dominant therapy of chronic myeloid leukemia., (Copyright 2013 Prous Science, S.A.U. or its licensors. All rights reserved.)

Published
2013
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37. Ponatinib for the treatment of chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia.

Author

Narayanan V, Pollyea DA, Gutman JA, and Jimeno A

Subjects
Animals, Antineoplastic Agents adverse effects, Antineoplastic Agents pharmacology, Drug Interactions, Drug Resistance, Neoplasm, Humans, Imidazoles adverse effects, Imidazoles pharmacology, Leukemia, Myelogenous, Chronic, BCR-ABL Positive pathology, Philadelphia Chromosome, Precursor Cell Lymphoblastic Leukemia-Lymphoma pathology, Protein Kinase Inhibitors administration & dosage, Protein Kinase Inhibitors pharmacology, Protein Kinase Inhibitors therapeutic use, Protein-Tyrosine Kinases antagonists & inhibitors, Pyridazines adverse effects, Pyridazines pharmacology, Antineoplastic Agents therapeutic use, Imidazoles therapeutic use, Leukemia, Myelogenous, Chronic, BCR-ABL Positive drug therapy, Precursor Cell Lymphoblastic Leukemia-Lymphoma drug therapy, Pyridazines therapeutic use
Abstract

Ponatinib is a novel, next-generation, small-molecule tyrosine kinase inhibitor with potent activity against the BCR-ABL fusion oncogene as well as all other ABL kinase domain mutations that confer resistance to earlier generation tyrosine kinase inhibitors. Due to its unique structure, it is the only tyrosine kinase inhibitor with the capability to counter the highly resistant T315I or gate-keeper mutation in leukemic cells that express the Philadelphia chromosome. This review will focus on the preclinical pharmacology, pharmacokinetics and clinical utility of ponatinib in the treatment of chronic myeloid leukemia and Philadelphia chromosome-positive adult acute lymphoblastic leukemia., (Copyright 2013 Prous Science, S.A.U. or its licensors. All rights reserved.)

Published
2013
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