The phase 3 DUO trial: duvelisib vs ofatumumab in relapsed and refractory CLL/SLL

Publication Date:
2018-12-07
Publisher:
American Society of Hematology (ASH)
Print ISSN:
0006-4971
Electronic ISSN:
1528-0020
Topics:
Biology
Medicine
Keywords:
Free Research Articles, Lymphoid Neoplasia, Clinical Trials and Observations
Published by:
http://www.hematology.org/
_version_ 1836399099109179392
autor Flinn, I. W., Hillmen, P., Montillo, M., Nagy, Z., Illes, A., Etienne, G., Delgado, J., Kuss, B. J., Tam, C. S., Gasztonyi, Z., Offner, F., Lunin, S., Bosch, F., Davids, M. S., Lamanna, N., Jaeger, U., Ghia, P., Cymbalista, F., Portell, C. A., Skarbnik, A. P., Cashen, A. F., Weaver, D. T., Kelly, V. M., Turnbull, B., Stilgenbauer, S.
beschreibung Duvelisib (also known as IPI-145) is an oral, dual inhibitor of phosphatidylinositol 3-kinase and (PI3K-,) being developed for treatment of hematologic malignancies. PI3K-, signaling can promote B-cell proliferation and survival in clonal B-cell malignancies, such as chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). In a phase 1 study, duvelisib showed clinically meaningful activity and acceptable safety in CLL/SLL patients. We report here the results of DUO, a global phase 3 randomized study of duvelisib vs ofatumumab monotherapy for patients with relapsed or refractory (RR) CLL/SLL. Patients were randomized 1:1 to oral duvelisib 25 mg twice daily (n = 160) or ofatumumab IV (n = 159). The study met the primary study end point by significantly improving progression-free survival per independent review committee assessment compared with ofatumumab for all patients (median, 13.3 months vs 9.9 months; hazard ratio [HR] = 0.52; P 〈 .0001), including those with high-risk chromosome 17p13.1 deletions [del(17p)] and/or TP53 mutations (HR = 0.40; P = .0002). The overall response rate was significantly higher with duvelisib (74% vs 45%; P 〈 .0001) regardless of del(17p) status. The most common adverse events were diarrhea, neutropenia, pyrexia, nausea, anemia, and cough on the duvelisib arm, and neutropenia and infusion reactions on the ofatumumab arm. The DUO trial data support duvelisib as a potentially effective treatment option for patients with RR CLL/SLL. This trial was registered at www.clinicaltrials.gov as #NCT02004522.
citation_standardnr 6365780
datenlieferant ipn_articles
feed_id 310
feed_publisher American Society of Hematology (ASH)
feed_publisher_url http://www.hematology.org/
insertion_date 2018-12-07
journaleissn 1528-0020
journalissn 0006-4971
publikationsjahr_anzeige 2018
publikationsjahr_facette 2018
publikationsjahr_intervall 7984:2015-2019
publikationsjahr_sort 2018
publisher American Society of Hematology (ASH)
quelle Blood
relation http://www.bloodjournal.org/cgi/content/short/132/23/2446?rss=1
schlagwort Free Research Articles, Lymphoid Neoplasia, Clinical Trials and Observations
search_space articles
shingle_author_1 Flinn, I. W., Hillmen, P., Montillo, M., Nagy, Z., Illes, A., Etienne, G., Delgado, J., Kuss, B. J., Tam, C. S., Gasztonyi, Z., Offner, F., Lunin, S., Bosch, F., Davids, M. S., Lamanna, N., Jaeger, U., Ghia, P., Cymbalista, F., Portell, C. A., Skarbnik, A. P., Cashen, A. F., Weaver, D. T., Kelly, V. M., Turnbull, B., Stilgenbauer, S.
shingle_author_2 Flinn, I. W., Hillmen, P., Montillo, M., Nagy, Z., Illes, A., Etienne, G., Delgado, J., Kuss, B. J., Tam, C. S., Gasztonyi, Z., Offner, F., Lunin, S., Bosch, F., Davids, M. S., Lamanna, N., Jaeger, U., Ghia, P., Cymbalista, F., Portell, C. A., Skarbnik, A. P., Cashen, A. F., Weaver, D. T., Kelly, V. M., Turnbull, B., Stilgenbauer, S.
shingle_author_3 Flinn, I. W., Hillmen, P., Montillo, M., Nagy, Z., Illes, A., Etienne, G., Delgado, J., Kuss, B. J., Tam, C. S., Gasztonyi, Z., Offner, F., Lunin, S., Bosch, F., Davids, M. S., Lamanna, N., Jaeger, U., Ghia, P., Cymbalista, F., Portell, C. A., Skarbnik, A. P., Cashen, A. F., Weaver, D. T., Kelly, V. M., Turnbull, B., Stilgenbauer, S.
shingle_author_4 Flinn, I. W., Hillmen, P., Montillo, M., Nagy, Z., Illes, A., Etienne, G., Delgado, J., Kuss, B. J., Tam, C. S., Gasztonyi, Z., Offner, F., Lunin, S., Bosch, F., Davids, M. S., Lamanna, N., Jaeger, U., Ghia, P., Cymbalista, F., Portell, C. A., Skarbnik, A. P., Cashen, A. F., Weaver, D. T., Kelly, V. M., Turnbull, B., Stilgenbauer, S.
shingle_catch_all_1 The phase 3 DUO trial: duvelisib vs ofatumumab in relapsed and refractory CLL/SLL
Free Research Articles, Lymphoid Neoplasia, Clinical Trials and Observations
Duvelisib (also known as IPI-145) is an oral, dual inhibitor of phosphatidylinositol 3-kinase and (PI3K-,) being developed for treatment of hematologic malignancies. PI3K-, signaling can promote B-cell proliferation and survival in clonal B-cell malignancies, such as chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). In a phase 1 study, duvelisib showed clinically meaningful activity and acceptable safety in CLL/SLL patients. We report here the results of DUO, a global phase 3 randomized study of duvelisib vs ofatumumab monotherapy for patients with relapsed or refractory (RR) CLL/SLL. Patients were randomized 1:1 to oral duvelisib 25 mg twice daily (n = 160) or ofatumumab IV (n = 159). The study met the primary study end point by significantly improving progression-free survival per independent review committee assessment compared with ofatumumab for all patients (median, 13.3 months vs 9.9 months; hazard ratio [HR] = 0.52; P < .0001), including those with high-risk chromosome 17p13.1 deletions [del(17p)] and/or TP53 mutations (HR = 0.40; P = .0002). The overall response rate was significantly higher with duvelisib (74% vs 45%; P < .0001) regardless of del(17p) status. The most common adverse events were diarrhea, neutropenia, pyrexia, nausea, anemia, and cough on the duvelisib arm, and neutropenia and infusion reactions on the ofatumumab arm. The DUO trial data support duvelisib as a potentially effective treatment option for patients with RR CLL/SLL. This trial was registered at www.clinicaltrials.gov as #NCT02004522.
Flinn, I. W., Hillmen, P., Montillo, M., Nagy, Z., Illes, A., Etienne, G., Delgado, J., Kuss, B. J., Tam, C. S., Gasztonyi, Z., Offner, F., Lunin, S., Bosch, F., Davids, M. S., Lamanna, N., Jaeger, U., Ghia, P., Cymbalista, F., Portell, C. A., Skarbnik, A. P., Cashen, A. F., Weaver, D. T., Kelly, V. M., Turnbull, B., Stilgenbauer, S.
American Society of Hematology (ASH)
0006-4971
00064971
1528-0020
15280020
shingle_catch_all_2 The phase 3 DUO trial: duvelisib vs ofatumumab in relapsed and refractory CLL/SLL
Free Research Articles, Lymphoid Neoplasia, Clinical Trials and Observations
Duvelisib (also known as IPI-145) is an oral, dual inhibitor of phosphatidylinositol 3-kinase and (PI3K-,) being developed for treatment of hematologic malignancies. PI3K-, signaling can promote B-cell proliferation and survival in clonal B-cell malignancies, such as chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). In a phase 1 study, duvelisib showed clinically meaningful activity and acceptable safety in CLL/SLL patients. We report here the results of DUO, a global phase 3 randomized study of duvelisib vs ofatumumab monotherapy for patients with relapsed or refractory (RR) CLL/SLL. Patients were randomized 1:1 to oral duvelisib 25 mg twice daily (n = 160) or ofatumumab IV (n = 159). The study met the primary study end point by significantly improving progression-free survival per independent review committee assessment compared with ofatumumab for all patients (median, 13.3 months vs 9.9 months; hazard ratio [HR] = 0.52; P < .0001), including those with high-risk chromosome 17p13.1 deletions [del(17p)] and/or TP53 mutations (HR = 0.40; P = .0002). The overall response rate was significantly higher with duvelisib (74% vs 45%; P < .0001) regardless of del(17p) status. The most common adverse events were diarrhea, neutropenia, pyrexia, nausea, anemia, and cough on the duvelisib arm, and neutropenia and infusion reactions on the ofatumumab arm. The DUO trial data support duvelisib as a potentially effective treatment option for patients with RR CLL/SLL. This trial was registered at www.clinicaltrials.gov as #NCT02004522.
Flinn, I. W., Hillmen, P., Montillo, M., Nagy, Z., Illes, A., Etienne, G., Delgado, J., Kuss, B. J., Tam, C. S., Gasztonyi, Z., Offner, F., Lunin, S., Bosch, F., Davids, M. S., Lamanna, N., Jaeger, U., Ghia, P., Cymbalista, F., Portell, C. A., Skarbnik, A. P., Cashen, A. F., Weaver, D. T., Kelly, V. M., Turnbull, B., Stilgenbauer, S.
American Society of Hematology (ASH)
0006-4971
00064971
1528-0020
15280020
shingle_catch_all_3 The phase 3 DUO trial: duvelisib vs ofatumumab in relapsed and refractory CLL/SLL
Free Research Articles, Lymphoid Neoplasia, Clinical Trials and Observations
Duvelisib (also known as IPI-145) is an oral, dual inhibitor of phosphatidylinositol 3-kinase and (PI3K-,) being developed for treatment of hematologic malignancies. PI3K-, signaling can promote B-cell proliferation and survival in clonal B-cell malignancies, such as chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). In a phase 1 study, duvelisib showed clinically meaningful activity and acceptable safety in CLL/SLL patients. We report here the results of DUO, a global phase 3 randomized study of duvelisib vs ofatumumab monotherapy for patients with relapsed or refractory (RR) CLL/SLL. Patients were randomized 1:1 to oral duvelisib 25 mg twice daily (n = 160) or ofatumumab IV (n = 159). The study met the primary study end point by significantly improving progression-free survival per independent review committee assessment compared with ofatumumab for all patients (median, 13.3 months vs 9.9 months; hazard ratio [HR] = 0.52; P < .0001), including those with high-risk chromosome 17p13.1 deletions [del(17p)] and/or TP53 mutations (HR = 0.40; P = .0002). The overall response rate was significantly higher with duvelisib (74% vs 45%; P < .0001) regardless of del(17p) status. The most common adverse events were diarrhea, neutropenia, pyrexia, nausea, anemia, and cough on the duvelisib arm, and neutropenia and infusion reactions on the ofatumumab arm. The DUO trial data support duvelisib as a potentially effective treatment option for patients with RR CLL/SLL. This trial was registered at www.clinicaltrials.gov as #NCT02004522.
Flinn, I. W., Hillmen, P., Montillo, M., Nagy, Z., Illes, A., Etienne, G., Delgado, J., Kuss, B. J., Tam, C. S., Gasztonyi, Z., Offner, F., Lunin, S., Bosch, F., Davids, M. S., Lamanna, N., Jaeger, U., Ghia, P., Cymbalista, F., Portell, C. A., Skarbnik, A. P., Cashen, A. F., Weaver, D. T., Kelly, V. M., Turnbull, B., Stilgenbauer, S.
American Society of Hematology (ASH)
0006-4971
00064971
1528-0020
15280020
shingle_catch_all_4 The phase 3 DUO trial: duvelisib vs ofatumumab in relapsed and refractory CLL/SLL
Free Research Articles, Lymphoid Neoplasia, Clinical Trials and Observations
Duvelisib (also known as IPI-145) is an oral, dual inhibitor of phosphatidylinositol 3-kinase and (PI3K-,) being developed for treatment of hematologic malignancies. PI3K-, signaling can promote B-cell proliferation and survival in clonal B-cell malignancies, such as chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). In a phase 1 study, duvelisib showed clinically meaningful activity and acceptable safety in CLL/SLL patients. We report here the results of DUO, a global phase 3 randomized study of duvelisib vs ofatumumab monotherapy for patients with relapsed or refractory (RR) CLL/SLL. Patients were randomized 1:1 to oral duvelisib 25 mg twice daily (n = 160) or ofatumumab IV (n = 159). The study met the primary study end point by significantly improving progression-free survival per independent review committee assessment compared with ofatumumab for all patients (median, 13.3 months vs 9.9 months; hazard ratio [HR] = 0.52; P < .0001), including those with high-risk chromosome 17p13.1 deletions [del(17p)] and/or TP53 mutations (HR = 0.40; P = .0002). The overall response rate was significantly higher with duvelisib (74% vs 45%; P < .0001) regardless of del(17p) status. The most common adverse events were diarrhea, neutropenia, pyrexia, nausea, anemia, and cough on the duvelisib arm, and neutropenia and infusion reactions on the ofatumumab arm. The DUO trial data support duvelisib as a potentially effective treatment option for patients with RR CLL/SLL. This trial was registered at www.clinicaltrials.gov as #NCT02004522.
Flinn, I. W., Hillmen, P., Montillo, M., Nagy, Z., Illes, A., Etienne, G., Delgado, J., Kuss, B. J., Tam, C. S., Gasztonyi, Z., Offner, F., Lunin, S., Bosch, F., Davids, M. S., Lamanna, N., Jaeger, U., Ghia, P., Cymbalista, F., Portell, C. A., Skarbnik, A. P., Cashen, A. F., Weaver, D. T., Kelly, V. M., Turnbull, B., Stilgenbauer, S.
American Society of Hematology (ASH)
0006-4971
00064971
1528-0020
15280020
shingle_title_1 The phase 3 DUO trial: duvelisib vs ofatumumab in relapsed and refractory CLL/SLL
shingle_title_2 The phase 3 DUO trial: duvelisib vs ofatumumab in relapsed and refractory CLL/SLL
shingle_title_3 The phase 3 DUO trial: duvelisib vs ofatumumab in relapsed and refractory CLL/SLL
shingle_title_4 The phase 3 DUO trial: duvelisib vs ofatumumab in relapsed and refractory CLL/SLL
timestamp 2025-06-30T23:37:35.338Z
titel The phase 3 DUO trial: duvelisib vs ofatumumab in relapsed and refractory CLL/SLL
titel_suche The phase 3 DUO trial: duvelisib vs ofatumumab in relapsed and refractory CLL/SLL
topic W
WW-YZ
uid ipn_articles_6365780