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11 results on '"le Coutre, Philipp"'

1. Asciminib monotherapy in patients with chronic-phase chronic myeloid leukemia with the T315I mutation after ≥1 prior tyrosine kinase inhibitor: 2-year follow-up results

Author

Cortes, Jorge E., Sasaki, Koji, Kim, Dong-Wook, Hughes, Timothy P., Etienne, Gabriel, Mauro, Michael J., Hochhaus, Andreas, Lang, Fabian, Heinrich, Michael C., Breccia, Massimo, Deininger, Michael, Goh, Yeow Tee, Janssen, Jeroen J.W.M., Talpaz, Moshe, de Soria, Valle Gomez Garcia, le Coutre, Philipp, DeAngelo, Daniel J., Damon, Andrea, Cacciatore, Silvia, Polydoros, Fotis, Agrawal, Nithya, and Rea, Delphine

Published
2024
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2. Asciminib monotherapy in patients with CML-CP without BCR::ABL1 T315I mutations treated with at least two prior TKIs: 4-year phase 1 safety and efficacy results

Author

Mauro, Michael J., Hughes, Timothy P., Kim, Dong-Wook, Rea, Delphine, Cortes, Jorge E., Hochhaus, Andreas, Sasaki, Koji, Breccia, Massimo, Talpaz, Moshe, Ottmann, Oliver, Minami, Hironobu, Goh, Yeow Tee, DeAngelo, Daniel J., Heinrich, Michael C., Gómez-García de Soria, Valle, le Coutre, Philipp, Mahon, Francois-Xavier, Janssen, Jeroen J. W. M., Deininger, Michael, Shanmuganathan, Naranie, Geyer, Mark B., Cacciatore, Silvia, Polydoros, Fotis, Agrawal, Nithya, Hoch, Matthias, and Lang, Fabian

Published
2023
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3. Asciminib vs bosutinib in chronic-phase chronic myeloid leukemia previously treated with at least two tyrosine kinase inhibitors: longer-term follow-up of ASCEMBL

Author

Hochhaus, Andreas, Réa, 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, le Coutre, Philipp, Sasaki, Koji, Kim, Dennis Dong Hwan, Saussele, Susanne, Annunziata, Mario, Chaudhri, Naeem, Chee, Lynette, García-Gutiérrez, Valentin, Kapoor, Shruti, Allepuz, Alex, Quenet, Sara, Bédoucha, Véronique, and Mauro, Michael J.

Published
2023
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5. Bosutinib versus imatinib for newly diagnosed chronic phase chronic myeloid leukemia: final results from the BFORE trial

Author

Brümmendorf, Tim H., Cortes, Jorge E., Milojkovic, Dragana, Gambacorti-Passerini, Carlo, Clark, Richard E., le Coutre, Philipp, Garcia-Gutierrez, Valentin, Chuah, Charles, Kota, Vamsi, Lipton, Jeffrey H., Rousselot, Philippe, Mauro, Michael J., Hochhaus, Andreas, Hurtado Monroy, Rafael, Leip, Eric, Purcell, Simon, Yver, Anne, Viqueira, Andrea, and Deininger, Michael W.

Published
2022
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6. Moxetumomab pasudotox in relapsed/refractory hairy cell leukemia.

Author

Kreitman, Robert, Dearden, Claire, Zinzani, Pier, Delgado, Julio, Karlin, Lionel, Robak, Tadeusz, Gladstone, Douglas, le Coutre, Philipp, Dietrich, Sascha, Gotic, Mirjana, Larratt, Loree, Offner, Fritz, Schiller, Gary, Swords, Ronan, Bacon, Larry, Bocchia, Monica, Bouabdallah, Krimo, Breems, Dimitri, Cortelezzi, Agostino, Dinner, Shira, Doubek, Michael, Gjertsen, Bjorn, Gobbi, Marco, Hellmann, Andrzej, Lepretre, Stephane, Maloisel, Frederic, Ravandi, Farhad, Rousselot, Philippe, Rummel, Mathias, Siddiqi, Tanya, Tadmor, Tamar, Troussard, Xavier, Yi, Cecilia, Saglio, Giuseppe, Roboz, Gail, Balic, Kemal, Standifer, Nathan, He, Peng, Marshall, Shannon, Wilson, Wyndham, Pastan, Ira, Yao, Nai-Shun, and Giles, Francis

Subjects
Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Bacterial Toxins, Drug Resistance, Neoplasm, Exotoxins, Female, Follow-Up Studies, Humans, Leukemia, Hairy Cell, Male, Middle Aged, Neoplasm Recurrence, Local, Prognosis, Remission Induction, Salvage Therapy, Survival Rate
Abstract

This is a pivotal, multicenter, open-label study of moxetumomab pasudotox, a recombinant CD22-targeting immunotoxin, in hairy cell leukemia (HCL), a rare B cell malignancy with high CD22 expression. The study enrolled patients with relapsed/refractory HCL who had ≥2 prior systemic therapies, including ≥1 purine nucleoside analog. Patients received moxetumomab pasudotox 40 µg/kg intravenously on days 1, 3, and 5 every 28 days for ≤6 cycles. Blinded independent central review determined disease response and minimal residual disease (MRD) status. Among 80 patients (79% males; median age, 60.0 years), durable complete response (CR) rate was 30%, CR rate was 41%, and objective response rate (CR and partial response) was 75%; 64 patients (80%) achieved hematologic remission. Among complete responders, 27 (85%) achieved MRD negativity by immunohistochemistry. The most frequent adverse events (AEs) were peripheral edema (39%), nausea (35%), fatigue (34%), and headache (33%). Treatment-related serious AEs of hemolytic uremic syndrome (7.5%) and capillary leak syndrome (5%) were reversible and generally manageable with supportive care and treatment discontinuation (6 patients; 7.5%). Moxetumomab pasudotox treatment achieved a high rate of independently assessed durable response and MRD eradication in heavily pretreated patients with HCL, with acceptable tolerability.

Published
2018

7. Treatment-free remission following frontline nilotinib in patients with chronic phase chronic myeloid leukemia: 5-year update of the ENESTfreedom trial

Author

Radich, Jerald P., Hochhaus, Andreas, Masszi, Tamás, Hellmann, Andrzej, Stentoft, Jesper, Casares, María Teresa Gómez, García-Gutiérrez, J. Valentín, Conneally, Eibhlin, le Coutre, Philipp D., Gattermann, Norbert, Martino, Bruno, Saussele, Susanne, Giles, Francis J., Ross, David M., Aimone, Paola, Li, Sai, Titorenko, Ksenia, and Saglio, Giuseppe

Published
2021
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8. Long-term outcomes with frontline nilotinib versus imatinib in newly diagnosed chronic myeloid leukemia in chronic phase: ENESTnd 10-year analysis

Author

Kantarjian, Hagop M., Hughes, Timothy P., Larson, Richard A., Kim, Dong-Wook, Issaragrisil, Surapol, le Coutre, Philipp, Etienne, Gabriel, Boquimpani, Carla, Pasquini, Ricardo, Clark, Richard E., Dubruille, Viviane, Flinn, Ian W., Kyrcz-Krzemien, Slawomira, Medras, Ewa, Zanichelli, Maria, Bendit, Israel, Cacciatore, Silvia, Titorenko, Ksenia, Aimone, Paola, Saglio, Giuseppe, and Hochhaus, Andreas

Published
2021
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9. Correction to: Long-term outcomes with frontline nilotinib versus imatinib in newly diagnosed chronic myeloid leukemia in chronic phase: ENESTnd 10-year analysis

Author

Kantarjian, Hagop M., Hughes, Timothy P., Larson, Richard A., Kim, Dong-Wook, Issaragrisil, Surapol, le Coutre, Philipp, Etienne, Gabriel, Boquimpani, Carla, Pasquini, Ricardo, Clark, Richard E., Dubruille, Viviane, Flinn, Ian W., Kyrcz-Krzemien, Slawomira, Medras, Ewa, Zanichelli, Maria, Bendit, Israel, Cacciatore, Silvia, Titorenko, Ksenia, Aimone, Paola, Saglio, Giuseppe, and Hochhaus, Andreas

Published
2021
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10. Asciminib monotherapy in patients with CML-CP without BCR::ABL1T315I mutations treated with at least two prior TKIs: 4-year phase 1 safety and efficacy results

Author

Mauro, Michael J., Hughes, Timothy P., Kim, Dong-Wook, Rea, Delphine, Cortes, Jorge E., Hochhaus, Andreas, Sasaki, Koji, Breccia, Massimo, Talpaz, Moshe, Ottmann, Oliver, Minami, Hironobu, Goh, Yeow Tee, DeAngelo, Daniel J., Heinrich, Michael C., Gómez-García de Soria, Valle, le Coutre, Philipp, Mahon, Francois-Xavier, Janssen, Jeroen J. W. M., Deininger, Michael, Shanmuganathan, Naranie, Geyer, Mark B., Cacciatore, Silvia, Polydoros, Fotis, Agrawal, Nithya, Hoch, Matthias, and Lang, Fabian

Abstract

Asciminib is approved for patients with Philadelphia chromosome–positive chronic-phase chronic myeloid leukemia (CML-CP) who received ≥2 prior tyrosine kinase inhibitors or have the T315I mutation. We report updated results of a phase 1, open-label, nonrandomized trial (NCT02081378) assessing the safety, tolerability, and antileukemic activity of asciminib monotherapy 10–200 mg once or twice daily in 115 patients with CML-CP without T315I (data cutoff: January 6, 2021). After ≈4-year median exposure, 69.6% of patients remained on asciminib. The most common grade ≥3 adverse events (AEs) included increased pancreatic enzymes (22.6%), thrombocytopenia (13.9%), hypertension (13.0%), and neutropenia (12.2%); all-grade AEs (mostly grade 1/2) included musculoskeletal pain (59.1%), upper respiratory tract infection (41.7%), and fatigue (40.9%). Clinical pancreatitis and arterial occlusive events (AOEs) occurred in 7.0% and 8.7%, respectively. Most AEs occurred during year 1; the subsequent likelihood of new events, including AOEs, was low. By data cutoff, among patients without the indicated response at baseline, 61.3% achieved BCR::ABL1≤ 1%, 61.6% achieved ≤0.1% (major molecular response [MMR]), and 33.7% achieved ≤0.01% on the International Scale. MMR was maintained in 48/53 patients who achieved it and 19/20 who were in MMR at screening, supporting the long-term safety and efficacy of asciminib in this population.

Published
2023
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11. ASXL1mutations predict inferior molecular response to nilotinib treatment in chronic myeloid leukemia

Author

Schönfeld, Lioba, Rinke, Jenny, Hinze, Anna, Nagel, Saskia N., Schäfer, Vivien, Schenk, Thomas, Fabisch, Christian, Brümmendorf, Tim H., Burchert, Andreas, le Coutre, Philipp, Krause, Stefan W., Saussele, Susanne, Safizadeh, Fatemeh, Pfirrmann, Markus, Hochhaus, Andreas, and Ernst, Thomas

Abstract

Gene mutations independent of BCR::ABL1have been identified in newly diagnosed patients with chronic myeloid leukemia (CML) in chronic phase, whereby mutations in epigenetic modifier genes were most common. These findings prompted the systematic analysis of prevalence, dynamics, and prognostic significance of such mutations, in a clinically well-characterized patient population of 222 CML patients from the TIGER study (CML-V) by targeted next-generation sequencing covering 54 myeloid leukemia-associated genes. In total, 53/222 CML patients (24%) carried 60 mutations at diagnosis with ASXL1being most commonly affected (n= 20). To study mutation dynamics, longitudinal deep sequencing analysis of serial samples was performed in 100 patients after 12, 24, and 36 months of therapy. Typical patterns of clonal evolution included eradication, persistence, and emergence of mutated clones. Patients carrying an ASXL1mutation at diagnosis showed a less favorable molecular response to nilotinib treatment, as a major molecular response (MMR) was achieved less frequently at month 12, 18, and 24 compared to all other patients. Patients with ASXL1mutations were also younger and more frequently found in the high risk category, suggesting a central role of clonal evolution associated with ASXL1mutations in CML pathogenesis.

Published
2022
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