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Journal Articles

Asciminib Demonstrates Superior Efficacy and Safety in Newly Diagnosed Chronic Myeloid Leukemia in the ASC4FIRST Trial

Blood blood.2025029210.

https://doi.org/10.1182/blood.2025029210

Published: 2025

Includes: Supplemental data

Journal Articles

Distinct patterns of mutant ASXL1 over time and their implications for treatment failure (TF) and BCR::ABL1 mutation development in newly diagnosed patients with chronic myeloid leukemia in chronic phase (CML-CP) treated with asciminib (ASC) vs investigator-selected tyrosine kinase inhibitors (IS-TKI) in the ASC4FIRST study

Blood (2025) 146 (Supplement 1): 73.

https://doi.org/10.1182/blood-2025-73

Published: 2025

Journal Articles

High rates of deep molecular response (DMR) in patients (pts) with chronic myeloid leukemia in chronic Phase (CML-CP) who have not achieved dmr after ≥1 year of prior imatinib (IMA) in the asciminib (ASC) monotherapy arm of the Phase 2 ASC4MORE study

Jorge Cortes, Giuseppe Saglio, Jan Geissler, Jiri Mayer, Gabriel Etienne, Michael Fillitz, Elvira Mora Casterá, Shruti Kapoor, Ana Paula Cardoso, Ugo Okoroji, Amila Sarac, Matthias Hoch, Sara Quenet, Timothy Hughes

Blood (2025) 146 (Supplement 1): 5552.

https://doi.org/10.1182/blood-2025-5552

Published: 2025

Journal Articles

Asciminib pediatric formulation shows a tolerable safety profile in pediatric patients with chronic myeloid leukemia in chronic phase (CML-CP): Second interim analysis from the ASC4KIDS study

Jessica Pollard, Hiroyuki Shimada, Shruti Kapoor, Matthias Hoch, Vishal Dhamal, Nithya Agrawal, Christine Rosko, Ana Paula Cardoso, Masakatsu Yanagimachi, Ho Joon Im, Markus Metzler, Nobuko Hijiya

Blood (2025) 146 (Supplement 1): 7312.

https://doi.org/10.1182/blood-2025-7312

Published: 2025

Journal Articles

Asciminib (ASC) demonstrates continued improvement in patient-reported outcomes (PROs) vs investigator-selected tyrosine kinase inhibitors (IS-TKIs) in newly diagnosed chronic myeloid leukemia (CML): ASC4FIRST week 96 analysis

Blood (2025) 146 (Supplement 1): 1997.

https://doi.org/10.1182/blood-2025-1997

Published: 2025

Journal Articles

Asciminib (ASC) Demonstrates Favorable Safety and Tolerability Compared with Each Investigator-Selected Tyrosine Kinase Inhibitor (IS TKI) in Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase (CML-CP) in the Pivotal Phase 3 ASC4FIRST Study

Jorge E. Cortes, Andreas Hochhaus, Timothy P Hughes, Jianxiang Wang, Dong-Wook Kim, Dennis Dong Hwan Kim, Jiri Mayer, Yeow Tee Goh, Philipp le Coutre, Gabriel Etienne, Naoto Takahashi, Inho Kim, David Andorsky, Ghayas C. Issa, Felice Bombaci, Shruti Kapoor, Rajendra Jinwal, Lillian Yau, Richard Larson

Blood (2024) 144 (Supplement 1): 475.

https://doi.org/10.1182/blood-2024-203757

Published: 2024

Journal Articles

Asciminib Provides Long-Term, Durable Molecular Responses in Patients with T315I-Mutated CML-CP: Final Analysis from a Phase 1 Trial

Blood (2024) 144 (Supplement 1): 1765.

https://doi.org/10.1182/blood-2024-209537

Published: 2024

Journal Articles

ASC4START and ASC4FIRST: Two Ongoing Phase 3 Trials Investigating Asciminib Monotherapy As First-Line Therapy Versus Tyrosine Kinase Inhibitors in Patients with Newly Diagnosed Philadelphia Chromosome-Positive Chronic Myeloid Leukemia in Chronic Phase

Andreas Hochhaus, Jorge Cortes, Naoto Takahashi, Richard A. Larson, Ghayas C. Issa, Felice Bombaci, Susanne Saussele, Francois Mahon, Tim H. Brümmendorf, Shruti Kapoor, Tracey McCulloch, Peter Schuld, Timothy P Hughes

Blood (2023) 142 (Supplement 1): 6388.

https://doi.org/10.1182/blood-2023-186773

Published: 2023

Journal Articles

ASC4KIDS: A Multicenter, Open-Label, Phase Ib/II Study to Determine the Dose and Safety of Asciminib in Pediatric Patients with Chronic Myeloid Leukemia in the Chronic Phase

Nobuko Hijiya, Shruti Kapoor, Matthias Hoch, Laurence Descamps, Vishal Dhamal, Ana Paula Torres Cardoso

Blood (2023) 142 (Supplement 1): 6387.

https://doi.org/10.1182/blood-2023-185535

Published: 2023

Journal Articles

Asciminib (ASC) Add-on to Imatinib (IMA) Demonstrates Sustained High Rates of Ongoing Therapy and Deep Molecular Responses (DMRs) with Prolonged Follow-up in the ASC4MORE Study

Timothy P Hughes, Giuseppe Saglio, Jan Geissler, Dong-Wook Kim, Elza Lomaia, Jiri Mayer, Anna Turkina, Shruti Kapoor, Ana Paula Torres Cardoso, Jomy Jose, Monali Sura, Jorge Cortes

Blood (2023) 142 (Supplement 1): 866.

https://doi.org/10.1182/blood-2023-182100

Published: 2023

Journal Articles

With up to 8 Years of Therapy, Asciminib (ASC) Monotherapy Demonstrated Continued Favorable Efficacy, Safety, and Tolerability in Patients (Pts) with Philadelphia Chromosome-Positive Chronic Myeloid Leukemia in Chronic Phase (Ph+ CML-CP) without the T315I Mutation: Final Results from the Phase 1 X2101 Study

Blood (2023) 142 (Supplement 1): 450.

https://doi.org/10.1182/blood-2023-187322

Published: 2023

Journal Articles

Sustained Efficacy and Safety with Asciminib (ASC) after Almost 4 Years of Median Follow-up from Ascembl, a Phase 3 Study of ASC Vs Bosutinib (BOS) in Patients (Pts) with Chronic Myeloid Leukemia in Chronic Phase (CML-CP) after ≥2 Prior Tyrosine Kinase Inhibitors (TKIs): An End of Study Treatment (EOS Tx) Update, Including Results from Switch Population

Blood (2023) 142 (Supplement 1): 4536.

https://doi.org/10.1182/blood-2023-186854

Published: 2023

Journal Articles

Justification for Asciminib Dosing in Patients with Philadelphia Chromosome-Positive Chronic Myeloid Leukemia (Ph+ CML-CP) with and without the T315I Mutation

Francois Pierre Combes, Ying Fei Li, Sherwin K.B. Sy, Sebastien Lorenzo, Kohinoor Dasgupta, Shruti Kapoor, Matthias Hoch, Yu-Yun Ho

Blood (2022) 140 (Supplement 1): 6791–6792.

https://doi.org/10.1182/blood-2022-163078

Published: 2022

Journal Articles

ASC4KIDS: A Multicenter, Open-Label, Phase Ib/II Study to Determine the Dose and Safety of Asciminib in Pediatric Patients with Chronic Myeloid Leukemia in Chronic Phase

Nobuko Hijiya, Shruti Kapoor, Matthias Hoch, Laurence Descamps, Kohinoor Dasgupta, Nicholas Ramscar

Blood (2022) 140 (Supplement 1): 12204–12205.

https://doi.org/10.1182/blood-2022-162451

Published: 2022

Journal Articles

ASC4FIRST: A Phase III Study of Asciminib vs Investigator-Selected Tyrosine Kinase Inhibitor in Patients with Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase (CML-CP)

Timothy Hughes, Jorge E. Cortes, Naoto Takahashi, Richard A. Larson, Ghayas C. Issa, Felice Bombaci, Nicholas Ramscar, Shruti Kapoor, Sophie Ifrah, Andreas Hochhaus

Blood (2022) 140 (Supplement 1): 6767–6768.

https://doi.org/10.1182/blood-2022-162249

Published: 2022

Journal Articles

Dynamics of Response and Response Factors in Patients (Pts) with Chronic Myeloid Leukemia in Chronic Phase (CML-CP) after ≥2 Prior Tyrosine Kinase Inhibitors (TKIs) in the Phase 3 Ascembl Study

Timothy Hughes, Delphine Rea, Carla Boquimpani, Yosuke Minami, Michael Mauro, Jorge E. Cortes, Jane F. Apperley, Valentín García Gutiérrez, Shruti Kapoor, Alex Allepuz, Sarah Quenet, Yifan Zhang, Andreas Hochhaus

Blood (2022) 140 (Supplement 1): 6757–6759.

https://doi.org/10.1182/blood-2022-169110

Published: 2022

Journal Articles

Trial in Progress: A Multicenter, Open-Label, Phase Ib/II Study to Determine the Dose and Safety of Asciminib in Pediatric Patients with Philadelphia Chromosome-Positive Chronic Myeloid Leukemia in Chronic Phase Treated with ≥1 Prior Tyrosine Kinase Inhibitor

Nobuko Hijiya, Shruti Kapoor, Laurence Descamps, Mohamed Amine Bayar, Nicholas Ramscar

Blood (2021) 138 (Supplement 1): 2561.

https://doi.org/10.1182/blood-2021-151198

Published: 2021

Journal Articles

Efficacy and Safety Results from Ascembl, a Multicenter, Open-Label, Phase 3 Study of Asciminib, a First-in-Class STAMP Inhibitor, Vs Bosutinib in Patients with Chronic Myeloid Leukemia in Chronic Phase after ≥2 Prior Tyrosine Kinase Inhibitors: Update after 48 Weeks

Blood (2021) 138 (Supplement 1): 310.

https://doi.org/10.1182/blood-2021-152561

Published: 2021

Journal Articles

Trial in Progress: A Multicenter, Open Label, Randomized, Phase III Study of Asciminib (80 mg Once Daily) Vs Investigator-Selected TKI in Newly Diagnosed Adult Patients with Chronic Myeloid Leukemia in Chronic Phase

Jorge E. Cortes, Andreas Hochhaus, Naoto Takahashi, Richard A. Larson, Ghayas C. Issa, Felice Bombaci, Nicholas Ramscar, Shruti Kapoor, Sophie Ifrah, Timothy P. Hughes

Blood (2021) 138 (Supplement 1): 1478.

https://doi.org/10.1182/blood-2021-151239

Published: 2021

Journal Articles

Randomized, Open-Label, Multicenter, Phase 2 Study of Asciminib (ABL001) As an Add-on to Imatinib Versus Continued Imatinib Versus Switch to Nilotinib in Patients with Chronic Myeloid Leukemia in Chronic Phase Who Have Not Achieved a Deep Molecular Response with Frontline Imatinib

Giuseppe Saglio, MD, Timothy P. Hughes, MDMBBS,FRACP,FRCPA, Jan Geissler, Shruti Kapoor, Anne-Sophie Longin, Ayon Mukherjee, Jorge E. Cortes, MD

Blood (2019) 134 (Supplement_1): 5910.

https://doi.org/10.1182/blood-2019-124702

Published: 2019

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Asciminib Demonstrates Superior Efficacy and Safety in Newly Diagnosed Chronic Myeloid Leukemia in the ASC4FIRST Trial

High rates of deep molecular response (DMR) in patients (pts) with chronic myeloid leukemia in chronic Phase (CML-CP) who have not achieved dmr after ≥1 year of prior imatinib (IMA) in the asciminib (ASC) monotherapy arm of the Phase 2 ASC4MORE study

Asciminib pediatric formulation shows a tolerable safety profile in pediatric patients with chronic myeloid leukemia in chronic phase (CML-CP): Second interim analysis from the ASC4KIDS study

Asciminib (ASC) demonstrates continued improvement in patient-reported outcomes (PROs) vs investigator-selected tyrosine kinase inhibitors (IS-TKIs) in newly diagnosed chronic myeloid leukemia (CML): ASC4FIRST week 96 analysis

Asciminib (ASC) Demonstrates Favorable Safety and Tolerability Compared with Each Investigator-Selected Tyrosine Kinase Inhibitor (IS TKI) in Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase (CML-CP) in the Pivotal Phase 3 ASC4FIRST Study

Asciminib Provides Long-Term, Durable Molecular Responses in Patients with T315I-Mutated CML-CP: Final Analysis from a Phase 1 Trial

ASC4START and ASC4FIRST: Two Ongoing Phase 3 Trials Investigating Asciminib Monotherapy As First-Line Therapy Versus Tyrosine Kinase Inhibitors in Patients with Newly Diagnosed Philadelphia Chromosome-Positive Chronic Myeloid Leukemia in Chronic Phase

ASC4KIDS: A Multicenter, Open-Label, Phase Ib/II Study to Determine the Dose and Safety of Asciminib in Pediatric Patients with Chronic Myeloid Leukemia in the Chronic Phase

Asciminib (ASC) Add-on to Imatinib (IMA) Demonstrates Sustained High Rates of Ongoing Therapy and Deep Molecular Responses (DMRs) with Prolonged Follow-up in the ASC4MORE Study

Justification for Asciminib Dosing in Patients with Philadelphia Chromosome-Positive Chronic Myeloid Leukemia (Ph+ CML-CP) with and without the T315I Mutation

ASC4KIDS: A Multicenter, Open-Label, Phase Ib/II Study to Determine the Dose and Safety of Asciminib in Pediatric Patients with Chronic Myeloid Leukemia in Chronic Phase

ASC4FIRST: A Phase III Study of Asciminib vs Investigator-Selected Tyrosine Kinase Inhibitor in Patients with Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase (CML-CP)

Dynamics of Response and Response Factors in Patients (Pts) with Chronic Myeloid Leukemia in Chronic Phase (CML-CP) after ≥2 Prior Tyrosine Kinase Inhibitors (TKIs) in the Phase 3 Ascembl Study

Trial in Progress: A Multicenter, Open-Label, Phase Ib/II Study to Determine the Dose and Safety of Asciminib in Pediatric Patients with Philadelphia Chromosome-Positive Chronic Myeloid Leukemia in Chronic Phase Treated with ≥1 Prior Tyrosine Kinase Inhibitor

Efficacy and Safety Results from Ascembl, a Multicenter, Open-Label, Phase 3 Study of Asciminib, a First-in-Class STAMP Inhibitor, Vs Bosutinib in Patients with Chronic Myeloid Leukemia in Chronic Phase after ≥2 Prior Tyrosine Kinase Inhibitors: Update after 48 Weeks

Trial in Progress: A Multicenter, Open Label, Randomized, Phase III Study of Asciminib (80 mg Once Daily) Vs Investigator-Selected TKI in Newly Diagnosed Adult Patients with Chronic Myeloid Leukemia in Chronic Phase

Randomized, Open-Label, Multicenter, Phase 2 Study of Asciminib (ABL001) As an Add-on to Imatinib Versus Continued Imatinib Versus Switch to Nilotinib in Patients with Chronic Myeloid Leukemia in Chronic Phase Who Have Not Achieved a Deep Molecular Response with Frontline Imatinib

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