The phase 3 DUO trial: duvelisib vs ofatumumab in relapsed and refractory CLL/SLL
Duvelisib (also known as IPI-145) is an oral, dual inhibitor of phosphatidylinositol 3-kinase δ and γ (PI3K-δ,γ) being developed for treatment of hematologic malignancies. PI3K-δ,γ signaling can promote B-cell proliferation and survival in clonal B-cell malignancies, such as chronic lymphocytic leuk...
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| Published in | Blood Vol. 132; no. 23; pp. 2446 - 2455 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
Elsevier Inc
06.12.2018
American Society of Hematology |
| Subjects | |
| Online Access | Get full text |
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| Abstract | Duvelisib (also known as IPI-145) is an oral, dual inhibitor of phosphatidylinositol 3-kinase δ and γ (PI3K-δ,γ) being developed for treatment of hematologic malignancies. PI3K-δ,γ 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.
•Duvelisib significantly improved progression-free survival and overall response rates compared with ofatumumab in RR CLL/SLL patients.•Duvelisib's efficacy and manageable safety profile support its consideration as a novel, oral monotherapy for RR CLL/SLL patients.
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| AbstractList | Abstract Duvelisib (also known as IPI-145) is an oral, dual inhibitor of phosphatidylinositol 3-kinase δ and γ (PI3K-δ,γ) being developed for treatment of hematologic malignancies. PI3K-δ,γ 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. Duvelisib (also known as IPI-145) is an oral, dual inhibitor of phosphatidylinositol 3-kinase δ and γ (PI3K-δ,γ) being developed for treatment of hematologic malignancies. PI3K-δ,γ 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. Duvelisib (also known as IPI-145) is an oral, dual inhibitor of phosphatidylinositol 3-kinase δ and γ (PI3K-δ,γ) being developed for treatment of hematologic malignancies. PI3K-δ,γ 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; < .0001), including those with high-risk chromosome 17p13.1 deletions [del(17p)] and/or mutations (HR = 0.40; = .0002). The overall response rate was significantly higher with duvelisib (74% vs 45%; < .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. Publisher's Note: There is a Blood Commentary on this article in this issue. Duvelisib significantly improved progression-free survival and overall response rates compared with ofatumumab in RR CLL/SLL patients. Duvelisib’s efficacy and manageable safety profile support its consideration as a novel, oral monotherapy for RR CLL/SLL patients. Duvelisib (also known as IPI-145) is an oral, dual inhibitor of phosphatidylinositol 3-kinase δ and γ (PI3K-δ,γ) being developed for treatment of hematologic malignancies. PI3K-δ,γ 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. Duvelisib (also known as IPI-145) is an oral, dual inhibitor of phosphatidylinositol 3-kinase δ and γ (PI3K-δ,γ) being developed for treatment of hematologic malignancies. PI3K-δ,γ 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. •Duvelisib significantly improved progression-free survival and overall response rates compared with ofatumumab in RR CLL/SLL patients.•Duvelisib's efficacy and manageable safety profile support its consideration as a novel, oral monotherapy for RR CLL/SLL patients. [Display omitted] Duvelisib (also known as IPI-145) is an oral, dual inhibitor of phosphatidylinositol 3-kinase δ and γ (PI3K-δ,γ) being developed for treatment of hematologic malignancies. PI3K-δ,γ 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.Duvelisib (also known as IPI-145) is an oral, dual inhibitor of phosphatidylinositol 3-kinase δ and γ (PI3K-δ,γ) being developed for treatment of hematologic malignancies. PI3K-δ,γ 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. |
| Author | Offner, Fritz Flinn, Ian W. Stilgenbauer, Stephan Illés, Árpád Lunin, Scott Jaeger, Ulrich Tam, Constantine S. Hillmen, Peter Gasztonyi, Zoltán Turnbull, Barry Davids, Matthew S. Montillo, Marco Lamanna, Nicole Weaver, David T. Bosch, Francesco Etienne, Gabriel Cashen, Amanda F. Kuss, Bryone J. Cymbalista, Florence Kelly, Virginia M. Portell, Craig A. Nagy, Zsolt Delgado, Julio Skarbnik, Alan P. Ghia, Paolo |
| Author_xml | – sequence: 1 givenname: Ian W. surname: Flinn fullname: Flinn, Ian W. email: iflinn@tnonc.com organization: Sarah Cannon Research Institute, Nashville, TN – sequence: 2 givenname: Peter surname: Hillmen fullname: Hillmen, Peter organization: St. James's Institute of Oncology, The Leeds Teaching Hospitals, Leeds, United Kingdom – sequence: 3 givenname: Marco surname: Montillo fullname: Montillo, Marco organization: Department of Haematology and Oncology, Niguarda Cancer Center, Niguarda Hospital, Milan, Italy – sequence: 4 givenname: Zsolt surname: Nagy fullname: Nagy, Zsolt organization: First Department of Internal Medicine, Semmelweis University, Budapest, Hungary – sequence: 5 givenname: Árpád surname: Illés fullname: Illés, Árpád organization: Department of Hematology, Faculty of Medicine, University of Debrecen, Debrecen, Hungary – sequence: 6 givenname: Gabriel surname: Etienne fullname: Etienne, Gabriel organization: Hematology Department, Institut Bergonie, Bordeaux, France – sequence: 7 givenname: Julio surname: Delgado fullname: Delgado, Julio organization: Hospital Clinic, Barcelona, Spain – sequence: 8 givenname: Bryone J. surname: Kuss fullname: Kuss, Bryone J. organization: Flinders Medical Centre-Flinders University, Bedford Park, SA, Australia – sequence: 9 givenname: Constantine S. surname: Tam fullname: Tam, Constantine S. organization: Peter MacCallum Cancer Centre, St. Vincent's Hospital and University of Melbourne, Melbourne, VIC, Australia – sequence: 10 givenname: Zoltán surname: Gasztonyi fullname: Gasztonyi, Zoltán organization: Department of Internal Medicine and Hematology, Petz Aladár County Hospital, Győr, Hungary – sequence: 11 givenname: Fritz surname: Offner fullname: Offner, Fritz organization: Hematology, University Hospital Ghent, Gent, Belgium – sequence: 12 givenname: Scott surname: Lunin fullname: Lunin, Scott organization: Florida Cancer Specialists, Venice, FL – sequence: 13 givenname: Francesco surname: Bosch fullname: Bosch, Francesco organization: Department of Hematology, University Hospital Vall d'Hebron, Barcelona, Spain – sequence: 14 givenname: Matthew S. surname: Davids fullname: Davids, Matthew S. organization: Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA – sequence: 15 givenname: Nicole surname: Lamanna fullname: Lamanna, Nicole organization: New York Presbyterian, Columbia University Medical Center, New York, NY – sequence: 16 givenname: Ulrich surname: Jaeger fullname: Jaeger, Ulrich organization: Division of Hematology and Hemostaseology, Department of Medicine I, Medical University of Vienna, Vienna, Austria – sequence: 17 givenname: Paolo surname: Ghia fullname: Ghia, Paolo organization: Universita' Vita-Salute San Raffaele and San Raffaele Scientific Institute, Milan, Italy – sequence: 18 givenname: Florence surname: Cymbalista fullname: Cymbalista, Florence organization: Laboratoire d’hématologie, Hôpital Avicenne, Paris, France – sequence: 19 givenname: Craig A. surname: Portell fullname: Portell, Craig A. organization: Division of Hematology and Oncology, University of Virginia, Charlottesville, VA – sequence: 20 givenname: Alan P. surname: Skarbnik fullname: Skarbnik, Alan P. organization: John Theurer Cancer Center, Hackensack Meridian Health, Hackensack, NJ – sequence: 21 givenname: Amanda F. surname: Cashen fullname: Cashen, Amanda F. organization: Siteman Comprehensive Cancer Center, Washington University, St. Louis, MO – sequence: 22 givenname: David T. surname: Weaver fullname: Weaver, David T. organization: Verastem Oncology, Needham, MA – sequence: 23 givenname: Virginia M. surname: Kelly fullname: Kelly, Virginia M. organization: Verastem Oncology, Needham, MA – sequence: 24 givenname: Barry surname: Turnbull fullname: Turnbull, Barry organization: Verastem Oncology, Needham, MA – sequence: 25 givenname: Stephan surname: Stilgenbauer fullname: Stilgenbauer, Stephan organization: Department III of Internal Medicine, University Hospital Ulm, Ulm, Germany |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/30287523$$D View this record in MEDLINE/PubMed https://sorbonne-paris-nord.hal.science/hal-04039967$$DView record in HAL |
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| Snippet | Duvelisib (also known as IPI-145) is an oral, dual inhibitor of phosphatidylinositol 3-kinase δ and γ (PI3K-δ,γ) being developed for treatment of hematologic... Abstract Duvelisib (also known as IPI-145) is an oral, dual inhibitor of phosphatidylinositol 3-kinase δ and γ (PI3K-δ,γ) being developed for treatment of... Publisher's Note: There is a Blood Commentary on this article in this issue. Duvelisib significantly improved progression-free survival and overall response... |
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| SubjectTerms | Adult Aged Aged, 80 and over Antibodies, Monoclonal - administration & dosage Antibodies, Monoclonal - adverse effects Antibodies, Monoclonal, Humanized Chromosome Deletion Chromosomes, Human, Pair 17 Clinical Trials and Observations Disease-Free Survival Double-Blind Method Female Humans Isoquinolines - administration & dosage Isoquinolines - adverse effects Leukemia, Lymphocytic, Chronic, B-Cell - drug therapy Leukemia, Lymphocytic, Chronic, B-Cell - genetics Leukemia, Lymphocytic, Chronic, B-Cell - mortality Life Sciences Male Middle Aged Purines - administration & dosage Purines - adverse effects Recurrence Smith-Magenis Syndrome Survival Rate Tumor Suppressor Protein p53 - genetics |
| Title | The phase 3 DUO trial: duvelisib vs ofatumumab in relapsed and refractory CLL/SLL |
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