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Journal Articles

Apex Part 2 Trial in Progress: A Phase 2 Open-Label Clinical Study of Bezuclastinib in Adult Patients with Advanced Systemic Mastocytosis

Isaac Goncalves, Stephen Fuller, Jason Gotlib, Pankit Vachhani, Vinod Pullarkat, Daniel J. DeAngelo, Saskia K. Klein, Wolfgang R. Sperr, Karin Hartmann, Khalid Shoumariyeh, Jens Panse, Teng Fong Ng, Miguel Piris-Villaespesa, Tsewang Tashi, Anthony M. Hunter, Prithviraj Bose, Cecilia Y. Arana Yi, Manish Jain, Helena Pomares, Tracy I. George, Jay Patel, Cristina Papayannidis, Minakshi S. Taparia, Bulai Livideanu Cridtina, Juliana Schwaab, Ingunn Dybedal, Jonathan Lambert, Tania Jain, Ewa Wierzbicka-Hainaut, Olivier Hermine, Massimiliano Bonifacio, Gabriela S. Hobbs, Michael W. Deininger, Amanda Pilla, Marcus Carden, Deepti H. Radia
Journal: Blood
Blood (2024) 144 (Supplement 1): 4569.1.
https://doi.org/10.1182/blood-2024-194550
Published: 2024
Journal Articles

Apex Part 1: Updated Assessment of Bezuclastinib (CGT9486), a Selective KIT D816V Tyrosine Kinase Inhibitor, in Patients with Advanced Systemic Mastocytosis (AdvSM)

Daniel J. DeAngelo, Jason Gotlib, Vinod Pullarkat, Pankit Vachhani, Tsewang Tashi, Stephanie Lee, Gary J. Schiller, Anthony M. Hunter, Miguel Piris-Villaespesa, Helena Pomares, Bulai Livideanu Cridtina, Khalid Shoumariyeh, Jonathan Lambert, Tracy I. George, Jay Patel, Cristina Papayannidis, Tania Jain, Michael W. Deininger, Andreas Reiter, Gabriela S. Hobbs, Lei Sun, Deepak Nagendra, Jenna Zhang, Amanda Pilla, Kim Dishman, Marcus Carden, Deepti H. Radia
Journal: Blood
Blood (2024) 144 (Supplement 1): 659.
https://doi.org/10.1182/blood-2024-193678
Published: 2024
Journal Articles

Ultra-Sensitive KIT testing Uncovers Previously Undetected KIT mutations in Patients with Indolent Systemic Mastocytosis: Results from the Pioneer Trial

Deepti H. Radia, Tsewang Tashi, Ivan Alvarez-Twose, Patrizia Bonadonna, Hanneke Oude Elberink, Sonia Cerquozzi, Tracy I. George, Guang Yang, Mark Rosenzweig, Hui-Min Lin, Ben Lampson, Rachel L. Erlich, Jason Gotlib
Journal: Blood
Blood (2024) 144 (Supplement 1): 3164.
https://doi.org/10.1182/blood-2024-207798
Published: 2024
Journal Articles

Hepatic Involvement in Advanced Systemic Mastocytosis: Clinical and Histopathological Correlates and Future Implications

Isabel Farmer, Anna C Green, Priya Sriskandarajah, Juliana Schwaab, Anton Rets, Deborah Moulton, Hayder KA Hussein, Susan Asirvatham, Tracy I. George, Andreas Reiter, Deepti H. Radia
Journal: Blood
Blood (2024) 144 (Supplement 1): 6627.
https://doi.org/10.1182/blood-2024-200591
Published: 2024
Journal Articles

Updated Efficacy and Safety Results of Patients Receiving Selected 100mg Bezuclastinib Dose and Participating in the Open-Label Extension of Summit: A Randomized, Double-Blind, Placebo Controlled Phase 2 Clinical Trial of Bezuclastinib in Adult Patients with Nonadvanced Systemic Mastocytosis

Lindsay A.M. Rein, Daniel J. DeAngelo, Brian Modena, Stephen Oh, Bulai Livideanu Cridtina, Celalettin Ustun, Nathan Boggs, Michael Manning, Anthony M. Hunter, Cem Akin, Arnold Kirshenbaum, Ingunn Dybedal, Cecilia Y. Arana Yi, Richard Herrscher, Mariana Castells, Frederick Lansigan, Tracy I. George, Jay Patel, Lei Sun, Nisha Shah, Jenna Zhang, Amanda Pilla, Priya Singh, Marcus Carden, Frank Siebenhaar, Prithviraj Bose
Journal: Blood
Blood (2024) 144 (Supplement 1): 4556.
https://doi.org/10.1182/blood-2024-194551
Published: 2024
Journal Articles

Disease-Modifying Effects of Avapritinib in Patients with Advanced Systemic Mastocytosis: Improvements in Bone Density

Johannes Luebke, Tracy I. George, Daniel J. DeAngelo, Jason Gotlib, Deepti H. Radia, Michael W. Deininger, Aaron Zakharyan, Joana Caetano-Lopes, Sasa Dimitrijevic, Andreas Reiter
Journal: Blood
Blood (2024) 144 (Supplement 1): 4544.
https://doi.org/10.1182/blood-2024-193774
Published: 2024
Journal Articles

Initial Results from Summit: An Ongoing, 3-Part, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Study of Bezuclastinib in Adult Patients with Nonadvanced Systemic Mastocytosis (NonAdvSM)

Prithviraj Bose, Stephen T. Oh, Brian Modena, Anthony M. Hunter, Cem Akin, Mariana Castells, Michael Manning, Richard Herrscher, Frank Siebenhaar, Daniel J. DeAngelo, Tracy I. George, Benjamin Exter, Jenna Zhang, Amanda Pilla, Hina Jolin, Rachael Easton, Lindsay A.M Rein
Journal: Blood
Blood (2023) 142 (Supplement 1): 77.
https://doi.org/10.1182/blood-2023-178927
Published: 2023
Journal Articles

Elenestinib, an Investigational, Next Generation KIT D816V Inhibitor, Reduces Mast Cell Burden, Improves Symptoms, and Has a Favorable Safety Profile in Patients with Indolent Systemic Mastocytosis: Analysis of the Harbor Trial

Tsewang Tashi, Olivier Hermine, Mariana Castells, Mar Guilarte, Vito Sabato, Marcus Maurer, Jens Panse, Ivan Alvarez-Twose, Renata Cabral, Robert Bird, Stéphane Barete, Laurence Bouillet, Maud Hermans, Paul Van Daele, David González-De-Olano, Elizabeth A. Griffiths, Joseph Jurcic, Ingunn Dybedal, Gandhi Laurent Damaj, Philippe Schafhausen, Chiara Elena, Tse-Chieh Teh, Pankit Vachhani, Caroline Labe, Saranya Venugopal, Kevin He, Javier Muñoz-González, Ben Lampson, Robyn Scherber, Prithviraj Bose, Clive Grattan, Thanai Pongdee, Tracy I. George, Cristina Bulai Livideanu
Journal: Blood
Blood (2023) 142 (Supplement 1): 76.
https://doi.org/10.1182/blood-2023-188904
Published: 2023
Journal Articles

Deep and Durable Cytogenetic and Molecular Responses with Pemigatinib in Myeloid/Lymphoid Neoplasms with Fibroblast Growth Factor Receptor 1 Rearrangement: The Fight-203 Study

Andreas Reiter, Jean-Jacques Kiladjian, Jay L. Patel, William Shomali, Alessandro Rambaldi, Srdan Verstovsek, Stephen Oh, Kensuke Usuki, Claire N Harrison, Ellen K. Ritchie, Luke P. Akard, Juan Carlos Hernandez Boluda, Françoise Huguet, Natalia Oliveira, Huiling Zhen, Tracy I. George, Philomena Colucci, Aidan Gilmartin, Jason Gotlib, Alessandro M. Vannucchi
Journal: Blood
Blood (2023) 142 (Supplement 1): 4551.
https://doi.org/10.1182/blood-2023-180945
Published: 2023
Journal Articles

Safety and Efficacy of Bezuclastinib (CGT9486), a Novel, Highly Selective, Potent KIT D816V Tyrosine Kinase Inhibitor, in Patients with Advanced Systemic Mastocytosis (AdvSM): Results from Part 1 of the Phase 2 Apex Trial

Pankit Vachhani, Tsewang Tashi, Gary J. Schiller, Stephanie Lee, Miguel Piris Villaespesa, Helena Pomares, Cristina Bulai Livideanu, Jonathan Lambert, Anthony M. Hunter, Tracy I. George, Cristina Papayannidis, Khalid Shoumariyeh, Rita Petroro, Jenna Zhang, Amanda Pilla, Hina Jolin, Rachael Easton, Vinod Pullarkat
Journal: Blood
Blood (2023) 142 (Supplement 1): 4567.
https://doi.org/10.1182/blood-2023-178885
Published: 2023
Journal Articles

Preliminary Safety and Efficacy from Apex, a Phase 2 Study of Bezuclastinib (CGT9486), a Novel, Highly Selective, Potent KIT D816V Tyrosine Kinase Inhibitor, in Adults with Advanced Systemic Mastocytosis (AdvSM)

Daniel J. DeAngelo, Vinod A. Pullarkat, Miguel Piris-Villaespesa, Tracy I. George, Jay L. Patel, Celalettin Ustun, Prithviraj Bose, Mark L Heaney, Jessica Sachs, Lei Sun, Amanda Pilla, Benjamin Exter, Hina A. Jolin, Tsewang Tashi
Journal: Blood
Blood (2022) 140 (Supplement 1): 1512–1513.
https://doi.org/10.1182/blood-2022-156311
Published: 2022
Journal Articles

Summit: A 3-Part, Phase 2 Study of Bezuclastinib (CGT9486), an Oral, Selective, and Potent KIT D816V Inhibitor, in Adult Patients with Nonadvanced Systemic Mastocytosis (NonAdvSM)

Cem Akin, Frank Siebenhaar, Michael W. Deininger, Daniel J. DeAngelo, Tracy I. George, Mariana Castells, Matthew Giannetti, Jason Gotlib, Jessica Sachs, Amanda Pilla, Hina A. Jolin, Prithviraj Bose
Journal: Blood
Blood (2022) 140 (Supplement 1): 6838–6839.
https://doi.org/10.1182/blood-2022-156326
Published: 2022
Journal Articles

Subclonal KIT D816V Mutations Are Prevalent in Chronic Myelomonocytic Leukemia and Correlate with Distinct Phenotypic Features

Anthony Hunter, Hannah Newman, Eric Solary, Klaus Geissler, Laura Palomo, Lurdes Zamora, Francesc Solé, Valeria Santini, Timothy A. Graubert, Swapna Thota, Elizabeth A. Griffiths, Lisa Pleyer, Felicitas R. Thol, Rafael Bejar, Luis E. Aguirre, David A. Sallman, Andrew Kuykendall, Rami S. Komrokji, Tracy I. George, Eric Padron
Journal: Blood
Blood (2022) 140 (Supplement 1): 9824–9827.
https://doi.org/10.1182/blood-2022-164816
Published: 2022
Journal Articles

Clonal Dynamics of ASM-AHN with Avapritinib Treatment

Xiaomeng Huang, Jonathan M. Ahmann, Opal S. Chen, Yi Qiao, Anthony D. Pomicter, Gabor T. Marth, Tracy I. George, Michael W. Deininger
Journal: Blood
Blood (2022) 140 (Supplement 1): 6737–6738.
https://doi.org/10.1182/blood-2022-167701
Published: 2022
Journal Articles

FIGHT-203, an Ongoing Phase 2 Study of Pemigatinib in Patients With Myeloid/Lymphoid Neoplasms (MLNs) With Fibroblast Growth Factor Receptor 1 ( FGFR1 ) Rearrangement (MLN FGFR1 ): A Focus on Centrally Reviewed Clinical and Cytogenetic Responses in Previously Treated Patients

Srdan Verstovsek, Jason Gotlib, Alessandro M. Vannucchi, Alessandro Rambaldi, Andreas Reiter, William Shomali, Tracy I. George, Jay L. Patel, Philomena Colucci, Huiling Zhen, Natalia Oliveira, Jean-Jacques Kiladjian
Journal: Blood
Blood (2022) 140 (Supplement 1): 3980–3982.
https://doi.org/10.1182/blood-2022-163099
Published: 2022
Journal Articles

Avapritinib As First-Line Therapy in Patients with Advanced Systemic Mastocytosis: Efficacy and Safety from the Pathfinder Clinical Study

Deepti H. Radia, Jason Gotlib, Mark W. Drummond, Tracy I. George, Hui-Min Lin, Saša Dimitrijević, Javier I. Munoz-Gonzalez, Ilda Bidollari, Michael W. Deininger, Daniel J. DeAngelo, Andreas Reiter
Journal: Blood
Blood (2022) 140 (Supplement 1): 1509–1511.
https://doi.org/10.1182/blood-2022-166986
Published: 2022
Journal Articles

AZURE: A Phase 1/2 Study of Blu-263 As Monotherapy and in Combination with Azacitidine in Patients with Advanced Systemic Mastocytosis

Daniel J. DeAngelo, Andreas Reiter, Tracy I. George, Deepti H. Radia, Marissa Devlin, Saša Dimitrijević, Mikael Rinne, Robyn Scherber, Jason Gotlib
Journal: Blood
Blood (2022) 140 (Supplement 1): 6877–6878.
https://doi.org/10.1182/blood-2022-167410
Published: 2022
Journal Articles

An Updated Analysis on Safety and Efficacy of Avapritinib in Patients with Advanced Systemic Mastocytosis from the Explorer Clinical Study: Long-Term Efficacy and Safety

Daniel J. DeAngelo, Deepti H. Radia, Tracy I. George, William A. Robinson, Albert T. Quiery, Mark W. Drummond, Prithviraj Bose, Elizabeth O. Hexner, Elliott Winton, Hans-Peter Horny, Meera Tugnait, Hui-Min Lin, Saša Dimitrijević, Javier I. Munoz-Gonzalez, Ilda Bidollari, Michael W. Deininger, Jason Gotlib
Journal: Blood
Blood (2022) 140 (Supplement 1): 3932–3934.
https://doi.org/10.1182/blood-2022-167593
Published: 2022
Journal Articles

A Phase 2 Study to Evaluate the Efficacy and Safety of Selinexor in Patients with Myelofibrosis Refractory or Intolerant to JAK Inhibitors

Srinivas K. Tantravahi, Soo Jin Kim, Divya Sundar, Ami B. Patel, Anthony D. Pomicter, Kenneth M. Boucher, Kamal Chamoun, Jatin Shah, Anton Rets, Tracy I. George, Josef T. Prchal, Michael W. Deininger
Journal: Blood
Blood (2021) 138 (Supplement 1): 143.
https://doi.org/10.1182/blood-2021-153940
Published: 2021
Journal Articles

Effective Control of Advance Systemic Mastocytosis with Avapritinib: Mutational Analysis from the Explorer Clinical Study

Michael W. Deininger, Daniel J. DeAngelo, Deepti H. Radia, Tracy I. George, Guang Yang, Jayita Sen, Hui-Min Lin, Brenton Mar, Jason Gotlib
Journal: Blood
Blood (2021) 138 (Supplement 1): 318.
https://doi.org/10.1182/blood-2021-150872
Published: 2021