ANDRE NEDER RAMIRES ABDO
Índice h a partir de 2011
8
Projetos de Pesquisa
Unidades Organizacionais
Instituto do Câncer do Estado de São Paulo, Hospital das Clínicas, Faculdade de Medicina - Médico
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Resultados de Busca
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article 20 Citação(ões) na Scopus 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 Previously Treated With >= 2 Tyrosine Kinase Inhibitors(2021) HOCHHAUS, Andreas; BOQUIMPANI, Carla; REA, Delphine; MINAMI, Yosuke; LOMAIA, Elza; VOLOSHIN, Sergey; TURKINA, Anna G.; KIM, Dong-Wook; APPERLEY, Jane; CORTES, Jorge E.; ABDO, Andre; FOGLIATTO, Laura Maria; KIM, Dennis Dong Hwan; COUTRE, Philipp D. le; SAUSSELE, Susanne; ANNUNZIATA, Mario; HUGHES, Timothy P.; CHAUDHRI, Naeem A.; CHEE, Lynette C. Y.; GUTIERREZ, Valentin Garcia; SASAKI, Koji; AIMONE, Paola; ALLEPUZ, Alex; QUENET, Sarah; BEDOUCHA, Veronique; MAURO, Michael J.- Asciminib vs bosutinib in chronic-phase chronic myeloid leukemia previously treated with at least two tyrosine kinase inhibitors: longer-term follow-up of ASCEMBL(2023) HOCHHAUS, Andreas; REA, Delphine; BOQUIMPANI, Carla; MINAMI, Yosuke; CORTES, Jorge E.; HUGHES, Timothy P.; APPERLEY, Jane F.; LOMAIA, Elza; VOLOSHIN, Sergey; TURKINA, Anna; KIM, Dong-Wook; ABDO, Andre; FOGLIATTO, Laura Maria; COUTRE, Philipp le; SASAKI, Koji; KIM, Dennis Dong Hwan; SAUSSELE, Susanne; ANNUNZIATA, Mario; CHAUDHRI, Naeem; CHEE, Lynette; GARCIA-GUTIERREZ, Valentin; KAPOOR, Shruti; ALLEPUZ, Alex; QUENET, Sara; BEDOUCHA, Veronique; MAURO, Michael J.Asciminib, the first BCR::ABL1 inhibitor that Specifically Targets the ABL Myristoyl Pocket (STAMP), is approved worldwide for the treatment of adults with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (CML-CP) treated with >= 2 prior tyrosine kinase inhibitors (TKIs). In ASCEMBL, patients with CML-CP treated with >= 2 prior TKIs were randomized (stratified by baseline major cytogenetic response [MCyR]) 2:1 to asciminib 40 mg twice daily or bosutinib 500 mg once daily. Consistent with previously published primary analysis results, after a median follow-up of 2.3 years, asciminib continued to demonstrate superior efficacy and better safety and tolerability than bosutinib. The major molecular response (MMR) rate at week 96 (key secondary endpoint) was 37.6% with asciminib vs 15.8% with bosutinib; the MMR rate difference between the arms, after adjusting for baseline MCyR, was 21.7% (95% CI, 10.53-32.95; two-sided p = 0.001). Fewer grade >= 3 adverse events (AEs) (56.4% vs 68.4%) and AEs leading to treatment discontinuation (7.7% vs 26.3%) occurred with asciminib than with bosutinib. A higher proportion of patients on asciminib than bosutinib remained on treatment and continued to derive benefit over time, supporting asciminib as a standard of care for patients with CML-CP previously treated with >= 2 TKIs.
- 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(2021) MAURO, Michael J.; MINAMI, Yosuke; REA, Delphine; HOCHHAUS, Andreas; LOMAIA, Elza; VOLOSHIN, Sergey; TURKINA, Anna G.; KIM, Dong-Wook; APPERLEY, Jane F.; CORTES, Jorge E.; ABDO, Andre N. R.; FOGLIATTO, Laura; KIM, Dennis Dong Hwan; COUTRE, Philipp D. le; SAUSSELE, Susanne; ANNUNZIATA, Mario; HUGHES, Timothy P.; CHAUDHRI, Naeem A.; CHEE, Lynette C. Y.; GUTIERREZ, Valentin Garcia; SASAKI, Koji; KAPOOR, Shruti; ALLEPUZ, Alex; QUENET, Sarah; BEDOUCHA, Veronique; BOQUIMPANI, Carla
- A phase 3, open-label, randomized study of asciminib, a STAMP inhibitor, vs bosutinib in CML after 2 or more prior TKIs(2021) REA, Delphine; MAURO, Michael J.; BOQUIMPANI, Carla; MINAMI, Yosuke; LOMAIA, Elza; VOLOSHIN, Sergey; TURKINA, Anna; KIM, Dong-Wook; APPERLEY, Jane F.; ABDO, Andre; FOGLIATTO, Laura Maria; KIM, Dennis Dong Hwan; COUTRE, Philipp le; SAUSSELE, Susanne; ANNUNZIATA, Mario; HUGHES, Timothy P.; CHAUDHRI, Naeem; SASAKI, Koji; CHEE, Lynette; GARCIA-GUTIERREZ, Valentin; CORTES, Jorge E.; AIMONE, Paola; ALLEPUZ, Alex; QUENET, Sara; BEDOUCHA, Veronique; HOCHHAUS, AndreasPatients with chronic myeloid leukemia in chronic phase (CML-CP) resistant/intolerant to >= 2 tyrosine kinase inhibitors (TKIs) are at high risk of experiencing poor outcomes because of disease biology and inadequate efficacy and/or safety of current therapies. Asciminib, a first-in-class BCR-ABL1 inhibitor Specifically Targeting the ABL Myristoyl Pocket (STAMP), has the potential to overcome resistance/intolerance to approved TKIs. In this phase 3, open-label study, patients with CML-CP previously treated with >= 2 TKIs were randomized (2:1) to receive asciminib 40 mg twice daily vs bosutinib 500 mg once daily. Randomization was stratified by major cytogenetic response (MCyR) status at baseline. The primary objective was to compare the major molecular response (MMR) rate at week 24 for asciminib vs bosutinib. A total of 233 patients were randomized to asciminib (n = 157) or bosutinib (n = 76). Median follow-up was 14.9 months. The MMR rate at week 24 was 25.5% with asciminib and 13.2% with bosutinib. The difference in MMR rate between treatment arms, after adjusting for MCyR at baseline, was 12.2% (95% confidence interval, 2.19-22.30; 2-sided P = .029). Fewer grade >= 3 adverse events (50.6% vs 60.5%) and adverse events leading to treatment discontinuation (5.8% vs 21.1%) occurred with asciminib than with bosutinib. The study showed a superior efficacy of asciminib compared with that of bosutinib, together with a favorable safety profile. These results support the use of asciminib as a new therapy in patients with CML-CP who are resistant/intolerant to >= 2 prior TKIs.
- Efficacy and Safety Results from ASCEMBL, a Multicenter, Open-Label, Phase 3 Study of Asciminib, a First-in-Class STAMP Inhibitor, vs Bosutinib (BOS) in Patients (Pts) with Chronic Myeloid Leukemia in Chronic Phase (CML-CP) Previously Treated with >= 2 Tyrosine Kinase Inhibitors (TKIs(2020) HOCHHAUS, Andreas; BOQUIMPANI, Carla; REA, Delphine; MINAMI, Yosuke; LOMAIA, Elza; VOLOSHIN, Sergey; TURKINA, Anna G.; KIM, Dong-Wook; APPERLEY, Jane; CORTES, Jorge E.; ABDO, Andre; FOGLIATTO, Laura Maria; KIM, Dennis Dong Hwan; COUTRE, Philipp D. Le; SAUSSELE, Susanne; ANNUNZIATA, Mario; HUGHES, Timothy P.; CHAUDHRI, Naeem A.; CHEE, Lynette C. Y.; GUTIERREZ, Valentin Garcia; SASAKI, Koji; AIMONE, Paola; ALLEPUZ, Alex; QUENET, Sarah; BEDOUCHA, Veronique; MAURO, Michael J.
conferenceObject 96-Week Update from the Phase 3 ASCEMBL Study for Evaluating the Safety and Efficacy of Asciminib versus Bosutinib in Patients with chronic phase chronic myeloid Leukemia after Pretreatment with 2 TKIs(2022) HOCHHAUS, A.; REA, D.; SAUSSELE, S.; BUSKE, S.; BALABANOV, S.; LANG, F.; SAUER, T.; GATTERMANN, N.; MAURO, M.; MINAMI, Y.; LOMAIA, E.; VOLOSHIN, S.; TURKINA, A.; KIM, D. -W; APPERLEY, J.; CORTES, J.; ABDO, A.; FOGLIATTO, L. M.; KIM, D.; ANNUNZIATA, M.; HUGHES, T.; CHAUDHRI, N.; CHEE, L.; GARCIA-GUTIERREZ, V; SASAKI, K.; KAPOOR, S.; ALLEPUZ, A.; QUENET, S.; BEDOUCHA, V; BOQUIMPANI, C.; COUTRE, P. le- Efficacy and safety of oral panobinostat plus subcutaneous bortezomib and oral dexamethasone in patients with relapsed or relapsed and refractory multiple myeloma (PANORAMA 3): an open-label, randomised, phase 2 study(2021) LAUBACH, Jacob P.; SCHJESVOLD, Fredrik; MARIZ, Mario; DIMOPOULOS, Meletios A.; LECH-MARANDA, Ewa; SPICKA, Ivan; HUNGRIA, Vania T. M.; SHELEKHOVA, Tatiana; ABDO, Andre; JACOBASCH, Lutz; POLPRASERT, Chantana; HAJEK, Roman; ILLES, Arpad; WROBEL, Tomasz; SUREDA, Anna; BEKSAC, Meral; GONCALVES, Iara Z.; BLADE, Joan; RAJKUMAR, S. Vincent; CHARI, Ajai; LONIAL, Sagar; SPENCER, Andrew; MAISON-BLANCHE, Pierre; MOREAU, Philippe; SAN-MIGUEL, Jesus F.; RICHARDSON, Paul G.Background Improved therapeutic options are needed for patients with relapsed or relapsed and refractory multiple myeloma. Subcutaneous bortezomib has replaced intravenous bortezomib as it is associated with a more favourable toxicity profile. We investigated the activity and safety of three different dosing regimens of oral panobinostat in combination with subcutaneous bortezomib and oral dexamethasone for this indication. Methods PANORAMA 3 is an open-label, randomised, phase 2 study being done at 71 sites (hospitals and medical centres) across 21 countries. Patients aged 18 years or older with relapsed or relapsed and refractory multiple myeloma (as per International Myeloma Working Group 2014 criteria), who had received one to four previous lines of therapy (including an immunomodulatory agent), and had an Eastern Cooperative Oncology Group performance status of 2 or lower, were randomly assigned (1:1:1) to receive oral panobinostat 20 mg three times weekly, 20 mg twice weekly, or 10 mg three times weekly, plus subcutaneous bortezomib and oral dexamethasone. All study drugs were administered in 21-day cycles. Randomisation was done by an interactive response technology provider, and stratified by number of previous treatment lines and age. The primary endpoint was overall response rate after up to eight treatment cycles (analysed in all randomly assigned patients by intention to treat). Safety analyses included all patients who received at least one dose of any study drug. No statistical comparisons between groups were planned. This trial is ongoing and registered with ClinicalTrials.gov, NCT02654990. Findings Between April 27,2016, and Jan 17,2019,248 patients were randomly assigned (82 to panobinostat 20 mg three times weekly, 83 to panobinostat 20 mg twice weekly, and 83 to 10 mg panobinostat three times weekly). Median duration of follow-up across all treatment groups was 14.7 months (IQR 7.8-24.1). The overall response rate after up to eight treatment cycles was 62.2% (95% CI 50.8-72.7; 51 of 82 patients) for the 20 mg three times weekly group, 65.1% (53.8-75.2; 54 of 83 patients) for the 20 mg twice weekly group, and 50.6% (39.4-61.8; 42 of 83 patients) for the 10 mg three times weekly group. Grade 3-4 adverse events occurred in 71 (91%) of 78 patients in the 20 mg three times weekly group, 69 (83%) of 83 patients in the 20 mg twice weekly group, and 60 (75%) of 80 patients in the 10 mg three times weekly group; the most common (>= 20% patients in any group) grade 3-4 adverse events were thrombocytopenia (33 142%1 of 78,26 [31%] of 83, and 19 [24%] of 83 patients) and neutropenia (18 [23%], 13 [16%], and six [8%]). Serious adverse events occurred in 42 (54%) of 78 patients in the 20 mg three times weekly group, 40 (48%) of 83 patients in the 20 mg twice weekly group, and 35 (44%) of 83 patients in the 10 mg three times weekly group; the most common serious adverse event (>= 10% patients in any group) was pneumonia (nine [12%[ of 78, ten [12%] of 83, and nine [11%] of 80 patients). There were 14 deaths during the study (five 16%1 of 78 patients in the 20 mg three times weekly group, three [4%] of 83 in the 20 mg twice weekly group, and six [8%] of 80 in the 10 mg three times weekly group); none of these deaths was deemed treatment related. Interpretation The safety profile of panobinostat 20 mg three times weekly was more favourable than in previous trials of this regimen with intravenous bortezomib, suggesting that subcutaneous bortezomib improves the tolerability of the panobinostat plus bortezomib plus dexamethasone regimen. The overall response rate was highest in the 20 mg three times weekly and 20 mg twice weekly groups, with 10 mg three times weekly best tolerated.