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Last update 21 Dec 2025

Duvelisib hydrate

Last update 21 Dec 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Duvelisib, 度恩西布, 杜韦利西布

+ [6]

Target

PI3Kγ x PI3Kδ

Action

inhibitors

Mechanism

PI3Kγ inhibitors(Phosphatidylinositol-4,5-Bisphosphate 3 kinase gamma inhibitors), PI3Kδ inhibitors(Phosphatidylinositol 3 kinase delta inhibitors)

Therapeutic Areas

NeoplasmsImmune System DiseasesHemic and Lymphatic Diseases+ [2]

Active Indication

Chronic Lymphocytic LeukemiaFollicular LymphomaSmall Lymphocytic Lymphoma+ [33]

Inactive Indication

Aggressive Non-Hodgkin LymphomaAsthmaCD20 positive Follicular Lymphoma+ [12]

Originator Organization

Infinity AS

Active Organization

Secura Bio, Inc.

Memorial Sloan Kettering Cancer Center

CSPC Zhongqi Pharmaceutical Technology Shijiazhuang Co., Ltd.

Inactive Organization

Infinity Pharmaceuticals, Inc.

CSPC Ouyi Pharmaceutical Co., Ltd.

CSPC Zhongqi Pharmaceutical Technology (Tianjin) Co., Ltd.

+ [2]

License Organization

Yakult Honsha Co., Ltd.

Verastem, Inc.

Mundipharma International Ltd.

+ [11]

Drug Highest PhaseApproved

First Approval Date

United States (24 Sep 2018),

Chronic Lymphocytic LeukemiaFollicular LymphomaSmall Lymphocytic Lymphoma

RegulationFast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Conditional marketing approval (China), Priority Review (China)

Structure/Sequence

Molecular FormulaC22H17ClN6O

InChIKeySJVQHLPISAIATJ-ZDUSSCGKSA-N

CAS Registry1201438-56-3

Clinical Trials associated with Duvelisib hydrate

NCT07293403

/ Not yet recruitingPhase 2IIT

A Phase II Study of Duvelisib Maintenance After First-Line Therapy for Peripheral T-Cell Lymphoma

This phase II trial tests how well duvelisib works as treatment that is given to help keep cancer from coming back after it has disappeared following the initial therapy (maintenance) for patients with peripheral T-cell lymphomas. Duvelisib is in a class of medications called kinase inhibitors. It works by blocking the signals that cause cancer cells to multiply. This helps to stop the spread of cancer cells.

Start Date07 Jun 2026

Sponsor / Collaborator

City of Hope National Medical Center

[+1]

NCT07001384

/ RecruitingPhase 1IIT

A Phase I Study of Alectinib Plus Duvelisib in Anaplastic Lymphoma Kinase-Positive Anaplastic Large Cell Lymphoma (ALK+ ALCL)

The researchers are doing this study to see if alectinib in combination with duvelisib is a safe and effective time-limited treatment for people with relapsed or refractory ALK+ anaplastic large cell lymphoma (ALCL). The researchers will test different doses of the study drugs to find the highest doses that cause few or mild side effects in participants. Once they find this dose combination, they will test it in a new group of participants to learn how long the effect of the combination lasts after the end of treatment

Start Date08 Aug 2025

Sponsor / Collaborator

Memorial Sloan Kettering Cancer Center

[+2]

NCT06522737

/ RecruitingPhase 3

A Multicentre, Open-label, Phase 3, Randomised Controlled Trial of Duvelisib Versus Investigator's Choice of Gemcitabine or Bendamustine in Patients With Relapsed/Refractory Nodal T Cell Lymphoma With T Follicular Helper (TFH) Phenotype

The study will evaluate the progression-free survival benefit of duvelisib monotherapy as compared to investigator's choice of gemcitabine or bendamustine in participants with relapsed/refractory nodal T cell lymphoma with TFH phenotype.

Start Date19 May 2025

Sponsor / Collaborator

Secura Bio, Inc.

100 Clinical Results associated with Duvelisib hydrate

100 Translational Medicine associated with Duvelisib hydrate

100 Patents (Medical) associated with Duvelisib hydrate

296

Literatures (Medical) associated with Duvelisib hydrate

01 Nov 2025·Clinical Lymphoma Myeloma & Leukemia

Dermatologic Adverse Events in Patients Receiving Duvelisib Single-Agent and Combination Therapies

Article

Author: Ganesan, Nivetha ; Dusza, Stephen ; Moskowitz, Alison ; Horwitz, Steven ; Liao, Viviane ; Geller, Shamir

BACKGROUND:

Duvelisib is a dual phosphoinositide 3 kinase (PI3K)-γ and -δ inhibitor currently approved for chronic lymphocytic leukemia and small lymphocytic lymphoma, with promise for T-cell lymphomas. Prior studies have characterized dermatologic adverse events (DAEs) associated with other PI3K inhibitors, but dedicated characterization of duvelisib-associated DAEs remains limited.

PATIENTS AND METHODS:

We retrospectively characterized possible, probable, or definite duvelisib-associated DAEs in 173 patients prescribed duvelisib primarily for T-cell lymphoma at our tertiary cancer center from 2000 to 2024.

RESULTS:

DAE incidence was 31.9% (n = 23/72) on single-agent duvelisib, 18.6% (n = 8/43) on duvelisib-romidepsin, 17.4% (n = 4/23) on duvelisib-bortezomib, and 5.7% (n = 2/35) on duvelisib-ruxolitinib. Most DAEs were maculopapular rash (51.4%), xerosis (16.2%), or mucositis (8.1%), with 24.3% being grade 3 or higher. We noted a lower incidence of DAEs in patients treated with duvelisib combination regimens compared to single-agent duvelisib (P = .004), with patients on single-agent duvelisib being 2.9 times more likely (95% CI, 1.4-6.2) to develop DAEs. Patients on combination therapy were also less likely to discontinue duvelisib due to DAEs (P < .05). Separately, rash occurring after duvelisib discontinuation was observed in 5.8% of patients on any duvelisib combination (n = 10), most of which were maculopapular (60.0%) with one being a case of Stevens Johnsons Syndrome. Rashes occurred within a median of 4 days following duvelisib discontinuation.

CONCLUSION:

Combining duvelisib with romidespin, bortezomib, or ruxolitinib reduced DAE incidence and allowed patients to remain on therapy. Further studies are required to delineate the effects of other agents on incidence and severity of PI3K inhibitor-associated DAEs.

01 Oct 2025·COMPUTATIONAL BIOLOGY AND CHEMISTRY

Identification of Therapeutic Compounds Targeting Phosphatidylinositol 3-Kinase (PI3K) Through Molecular Docking, Dynamics Simulation, and DFT Calculations

Article

Author: Zaki, Magdi E A ; Bayıl, Imren ; Al-Dies, Al-Anood M ; Oliveira, Jonas Ivan Nobre ; Silva, Gabriel Vinícius Rolim ; Alqahtani, Taha ; Guendouzi, Abdelkrim ; Tayyeb, Jehad Zuhair ; Alves, Guilherme Bastos

Cancer is one of the leading causes of death worldwide and characterized by uncontrolled cell proliferation. The phosphatidylinositol 3-kinase (PI3K) is an enzyme, which is essential for regulating cell growth and survival, is often dysregulated in tumors. Currently available PI3K inhibitors (like Duvelisib) have significant side effects, highlighting the need for safer therapeutics. Gallic acid, a natural phenolic compound with remarkable antineoplastic properties, showcases a promising scaffold for drug development. The aim of this study is to identify potential PI3K inhibitors from gallic acid derivatives using advanced computational techniques such as PASS prediction, molecular docking, ADMET (Absorption, Distribution, Metabolism, Excretion, and Toxicity) analysis, density functional theory (DFT) calculations, and molecular dynamics (MD) simulations. Five derivatives 21, 37, 44, 68 and 75 were selected based on their predicted antineoplastic activity among 90 derivatives, as well as the control drug Duvelisib. Compound 68 proved to be the most promising candidate, exhibiting strong binding affinity to the PI3K receptor, forming multiple hydrogen bonds with key residues, and showing stable interactions over 500 ns MD simulation. ADMET analysis revealed that compound 68 had favorable pharmacokinetic properties. Compound 21 also showed strong binding affinity but exhibited limitations in its pharmacokinetic profile. This study aims to improve our understanding of ligand-protein dynamics in PI3K inhibition and highlight the potential of gallic acid derivatives in developing safer and more effective PI3K inhibitors for cancer therapy. Our results support further experimental validation of compound 68 and suggest that gallic acid derivatives could contribute to the development of safer therapies.

01 Sep 2025·JOURNAL OF CUTANEOUS MEDICINE AND SURGERY

Management of Mycosis Fungoides and Sézary Syndrome With Oral Systemic Therapies

Review

Author: Strowd, Lindsay C. ; Ruley, Ainsley J. ; Thakker, Sach ; Eichinger, Justin M. ; Greenzaid, Jonathan D.

Mycosis fungoides (MF) and Sézary syndrome (SS) are subtypes of cutaneous T-cell lymphoma with numerous topical and systemic therapies. Early-stage MF can be managed with topical corticosteroids, mechlorethamine, and phototherapy. However, patients are often non-responsive to topical therapies, thus requiring systemic therapies. There are few studies summarizing oral (PO) therapies for MF and SS. We aim to discuss the efficacy and safety of FDA-approved, off-label, and investigational oral therapies for MF and SS. FDA-approved oral therapies include bexarotene and vorinostat, both of which are effective in patients who are recalcitrant to prior topical therapies. Off-label oral therapies include methotrexate, acitretin, and chlorambucil. Methotrexate improves MF lesions in both early-stage and late-stage MF and is effective in erythrodermic MF. A combination of acitretin with phototherapy may lead to better response rates compared to acitretin monotherapy. Chlorambucil is mainly used to treat erythrodermic MF. Investigational oral therapies for MF include tenalisib, duvelisib, cerdulatinib, lenalidomide, bortezomib, and azacytidine, and direct comparison studies between these investigational agents and FDA-approved therapies should be undertaken to better understand their role in the management of MF and SS.

News (Medical) associated with Duvelisib hydrate

17 Dec 2025

·www.globenewswire.com

Secura Bio Announces NCCN® Duvelisib (COPIKTRA®) Update to Clinical Practice Guidelines in Oncology for Cutaneous T-Cell Lymphoma (CTCL), Including Mycosis Fungoides and Sézary Syndrome

BERKELEY HEIGHTS, N.J., Dec. 17, 2025 (GLOBE NEWSWIRE) -- Secura Bio, Inc. (www.securabio.com), an integrated pharmaceutical company maximizing commercial outcomes for oncology medicines, today announced that duvelisib (COPIKTRA®) was added by the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) as a NCCN Category 2A treatment option for mycosis fungoides / Sézary Syndrome (MFSS). “We are very pleased to see COPIKTRA (duvelisib) added as a treatment option in the NCCN Guidelines for patients with CTCL (MFSS). We appreciate NCCN’s recognition of evidence showing COPIKTRA, as an oral dual PI3K inhibitor, to be a clinically important option in the treatment of T cell lymphomas,” said Dr. Christiane Langer, Senior Vice President, Head of Clinical & Medical Affairs at Secura Bio. “COPIKTRA is approved by the U.S. Food and Drug Administration for patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (r/r CLL/SLL). The NCCN Guidelines also recommend COPIKTRA for relapsed/refractory peripheral T-cell lymphoma (PTCL). Currently we are advancing a Phase 3 trial (TERZO) evaluating COPIKTRA in patients with relapsed/refractory nodal T-cell lymphoma with a T follicular helper (TFH) phenotype. We look forward to building the clinical evidence that further defines COPIKTRA’s role across T-cell lymphomas where successful treatment options have proven challenging.” The recommendation to add COPIKTRA (duvelisib) to the NCCN Guidelines is based on the broad body of evidence and uniform consensus (>85% support of the NCCN Panel) that intervention is appropriate. The updated NCCN Guidelines including recommended dosing are available at www.nccn.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. About Mycosis fungoides and Sezary syndrome (MFSS)Mycosis fungoides and Sézary syndrome are the two most common types of cutaneous T cell lymphoma, a type of non-Hodgkin lymphoma, characterized by malignant T cells in the blood. Mycosis fungoides is characterized by red skin lesions that can progress through various stages, including patches, plaques, and tumors. Sézary Syndrome is a leukemic variant of mycosis fungoides characterized by erythroderma, generalized lymphadenopathy, and the presence of malignant T cells in the blood. About Peripheral T-cell LymphomaPeripheral T-cell lymphoma (PTCL) is a rare, aggressive type of non-Hodgkin lymphoma that develops in mature white blood cells that circulate through the bloodstream and lymphatic system. PTCL accounts for between 10-15% of all non-Hodgkin lymphomas and generally affects people aged 60 years and older. Although there are many different subtypes of PTCL, they often present with widespread, enlarged, typically painless lymph nodes in the neck, armpit, and/or groin. There are currently no well-established standards of care for patients with relapsed or refractory disease. About nodal T-Follicular Helper Cell LymphomaNodal T-follicular helper cell lymphomas (nTFHL) comprise a group of aggressive non-Hodgkin lymphomas that share common genetic, clinical, and cell of origin features. This group of lymphomas originates from a type of white blood cell called a T-follicular helper cell. nTFHLs generally occur in people aged 60 and older and are slightly more common in males. nTFHLs most commonly present with widespread, enlarged, typically painless lymph nodes in the neck, armpit, and/or groin, in addition to rashes, B-symptoms, and immune dysregulation. There are currently no well-established standards of care for patients with relapsed or refractory disease. About COPIKTRA (duvelisib)COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase (PI3K) and the first US approved dual inhibitor of PI3K-delta and PI3K-gamma pathways, two enzymes known to help support the growth and survival of malignant cells. PI3K signaling may lead to the proliferation of malignant cells and is thought to play a role in the formation and maintenance of a supportive tumor microenvironment. COPIKTRA is indicated in the United States for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies. COPIKTRA is also being developed for the treatment of peripheral T-cell lymphoma (PTCL), for which it has received Fast Track status in the United States and is being investigated in combination with other agents through investigator-sponsored studies. Treatment of T-cell lymphomas is a disease category for which COPIKTRA is not currently indicated. For more information on COPIKTRA, please visit www.COPIKTRA.com. Information about duvelisib clinical trials can be found on www.clinicaltrials.gov. IMPORTANT SAFETY INFORMATION ABOUT COPIKTRA WARNING: FATAL AND SERIOUS TOXICITIES: INFECTIONS, DIARRHEA OR COLITIS, CUTANEOUS REACTIONS, and PNEUMONITIS See full prescribing information for complete boxed warning Treatment-related mortality occurred in 15% of COPIKTRA-treated patients.Fatal and/or serious infections occurred in 31%of COPIKTRA-treated patients. Monitor for signs and symptoms of infection. Withhold COPIKTRA if infection is suspected.Fatal and/or serious diarrhea or colitis occurred in 18% of COPIKTRA-treated patients. Monitor for the development of severe diarrhea or colitis. Withhold COPIKTRA.Fatal and/or serious cutaneous reactions occurred in 5% of COPIKTRA-treated patients. Withhold COPIKTRA.Fatal and/or serious pneumonitis occurred in 5% of COPIKTRA-treated patients. Monitor for pulmonary symptoms and interstitial infiltrates. Withhold COPIKTRA. INDICATIONS AND USAGECOPIKTRA is a kinase inhibitor indicated for the treatment of adult patients with:Relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies. Limitations of Use: COPIKTRA is not indicated or recommended for the treatment of any patients with CLL or SLL as initial or second line treatment due to an increased risk of treatment-related mortality. WARNINGS AND PRECAUTIONS Hepatotoxicity: Monitor hepatic function.Neutropenia: Monitor blood counts.Embryo-Fetal toxicity: COPIKTRA can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception. ADVERSE REACTIONSThe most common adverse reactions (≥20%) are diarrhea or colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper respiratory infection, pneumonia, musculoskeletal pain, and anemia. DRUG INTERACTIONS CYP3A4 inducers: Avoid co-administration with strong or moderate CYP3A4 inducers.CYP3A4 inhibitors: Monitor for COPIKTRA toxicities when co-administered with strong or moderate CYP3A4 inhibitors. Reduce COPIKTRA dose to 15 mg twice daily when co-administered with strong CYP3A4 inhibitors.CYP3A4 substrates: Monitor for signs of toxicities when co-administering COPIKTRA with sensitive CYP3A substrates. USE IN SPECIFIC POPULATIONSLactation: Advise women not to breastfeed. Please see complete Prescribing information, including boxed warning, at: www.copiktra.com. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088. About Secura Bio, Inc.Secura Bio is an integrated, commercial-stage pharmaceutical company dedicated to the worldwide development and commercialization of impactful oncology therapies for physicians and their patients. For more information on Secura Bio, please visit https://www.securabio.com/. Investor ContactWill BrownChief Financial OfficerPhone: 619-986-1364ir@securabio.com Media ContactKit RodopheleTen Bridge CommunicationsPhone: 617-999-9620krodophele@tenbridgecommunications.com

Drug ApprovalPhase 3Fast Track

08 Dec 2025

·www.globenewswire.com

Secura Bio Presents Extended Follow Up Analyses from Phase 2 PRIMO Trial in Patients with Relapsed/Refractory peripheral T-cell lymphoma at the 2025 American Society of Hematology Meeting

Longer-term analyses reinforce duvelisib’s activity across treatment-experienced PTCL populations, including patients with ≥3 prior lines of therapy, with no new safety signals emerging over time. Findings further strengthen rationale for ongoing global Phase 3 TERZO study in nodal TFH lymphoma. Dec. 07, 2025 -- Secura Bio, Inc. , an integrated pharmaceutical company maximizing commercial outcomes for oncology medicines, today presented extended follow up analyses examining additional safety data and impact of prior lines of therapy from the Company’s Phase 2 PRIMO trial (NCT03372057) at the 2025 American Society of Hematology (ASH) Annual Meeting. The results continue to show that duvelisib delivers meaningful clinical activity with a manageable safety profile, even in heavily pretreated patients, underscoring its potential role across a broad PTCL population. The poster, titled “Duvelisib in patients with relapsed/refractory peripheral T-cell lymphoma: from the Phase 2 PRIMO trial – impact of prior therapy and expanded safety analysis”, was presented by Professor Pier Luigi Zinzani, Head of Hematology at the University of Bologna/Italy, and highlighted new analyses of the dose expansion phase of the PRIMO trial, which included a group of 123 patients who had received at least 2 cycles of one standard regimen. The PRIMO clinical trial was a global, multicenter, open-label, single-arm trial that evaluated the investigational use of duvelisib for the treatment of adult patients with R/R PTCL. “PTCL patients often cycle through multiple treatments with little improvement in outcomes,” said Prof. Zinzani. “Seeing consistent efficacy even in those with ≥3 prior lines, and without emergent safety concerns at the recommended 75 mg lead-in dose, is highly encouraging. These results reinforce duvelisib’s therapeutic potential across this difficult-to-treat population.” In the PRIMO expansion phase duvelisib was dosed at 75 mg twice daily for two cycles and followed by 25 mg twice daily, and the primary endpoint was Overall Response Rate (ORR). New extended analyses demonstrated there was no consistent impact on efficacy outcomes for patients related to number of prior lines of treatment. In patients with 1, 2, and ≥3 prior lines of therapy, outcomes were as follows, respectively: ORR was 29%, 66%, 49%; complete response (CR) was 18%, 52%, 32%; median duration of response (DOR) was 6.5, 11.7, 7.9 months; median progression-free survival (mPFS) was 1.9, 9.0, 3.0 months, and median overall survival (OS) was 30.2, 22.7, 7.3 months. Interestingly, patients with more heavily pretreated disease demonstrated numerically favorable outcomes. In the analyses, 68% percent of patients received prior CHOP-based therapy, 35% had salvage chemotherapy, 20% had autologous stem cell transplant, 17% had an HDAC inhibitor, and 38% had prior exposure to brentuximab vedotin. Additionally, expanded safety analyses based on the number of dose cycles, where 123 patients received ≤2 cycles, 63 patients received >2 to 6 cycles, and 25 patients continued on to receive >6 cycles, revealed there was no consistent pattern of higher rates of persisting or emerging AEs with longer treatment duration. Rates of diarrhea showed a modest trend of increase, but there was no increase in rates of colitis. Adverse events (AEs) in ≥20% of patients by treatment duration included: neutropenia, aminotransferase increase, diarrhea, thrombocytopenia, leukopenia, and fatigue. Grade ≥3 adverse events in ≥5% of patients included: neutropenia, aminotransferase increase, maculopapular rash, thrombocytopenia, lymphopenia, diarrhea, hypokalemia and hypoxia. “These new analyses capture important insights on the many different profiles and treatment experiences of PTCL patients in our trial and demonstrate the efficacy and safety of duvelisib, regardless of baseline treatment characteristics and prior lines of treatment across the patient population,” said Dr. Christiane Langer, SVP, Head of Clinical and Medical Affairs at Secura Bio. “Secura Bio is committed to expanding the potential of this therapy and other existing oncology medicines to new cancer indications so that more patients have an opportunity to explore a medicine that may truly benefit them and extend their life.” Previously, final data presented last year at ASH show outcomes including an ORR of 48% (59/123), with a CR rate of 33.3% (41/123). The mDOR was 7.9 months, the mPFS was 3.4 months with a mPFS by baseline histology of 8.3 months (AITL), 3.4 months (PTCL-NOS), and 1.6 months (ALCL), and the mOS was 12.4 months. The most common baseline histologies were PTCL-NOS, AITL, and ALCL. ORRs by baseline histology were 62.2% (AITL), 49.1% (PTCL-NOS), and 15.0% (ALCL). Efficacy in the AITL group was notably favorable, with AITL subgroup outcomes as follows: ORR (62%), CRR (51%), mDOR 11.7 months, mPFS 8.3 months, and mOS 18.1 months. The strength of these findings directly informed the ongoing Phase 3 TERZO trial (NCT06522737) in relapsed/refractory nodal T-follicular helper cell lymphoma (nTFHL), now actively enrolling at over 40 centers in Europe. Peripheral T-cell lymphoma (PTCL) is a rare, aggressive type of non-Hodgkin lymphoma that develops in mature white blood cells that circulate through the bloodstream and lymphatic system. PTCL accounts for between 10-15% of all non-Hodgkin lymphomas and generally affects people aged 60 years and older. Although there are many different subtypes of PTCL, they often present in a similar way, with widespread, enlarged, typically painless lymph nodes in the neck, armpit, and/or groin. There are currently no well-established standards of care for patients with relapsed or refractory disease. Nodal T-follicular helper cell lymphomas (nTFHL) comprise a group of aggressive non-Hodgkin lymphomas that share common genetic, clinical, and cell of origin features. This group of lymphomas originates from a type of white blood cell called a T-follicular helper cell. nTFHLs generally occur in people aged 60 and older and are slightly more common in males. nTFHLs most commonly present with widespread, enlarged, typically painless lymph nodes in the neck, armpit, and/or groin, in addition to rashes, B-symptoms, and immune dysregulation. There are currently no well-established standards of care for patients with relapsed or refractory disease. COPIKTRA (duvelisib) is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first US approved dual inhibitor of PI3K-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant cells. PI3K signaling may lead to the proliferation of malignant cells and is thought to play a role in the formation and maintenance of a supportive tumor microenvironment. Secura Bio, Inc. is an integrated, commercial-stage pharmaceutical company dedicated to the worldwide development and commercialization of impactful oncology therapies for physicians and their patients. The content above comes from the network. if any infringement, please contact us to modify.

$Secura Bio Presents Extended Follow Up Analyses from Phase 2 PRIMO Trial in Patients with Relapsed/Refractory peripheral T-cell lymphoma at the 2025 American Society of Hematology Meeting$

Clinical ResultASHDrug Approval

04 Nov 2025

·www.globenewswire.com

Secura Bio Announces Poster Presentation Highlighting Extended Follow Up Analyses from Phase 2 PRIMO Trial at the 2025 American Society of Hematology Meeting

BERKELEY HEIGHTS, N. J., Nov. 04, 2025 (GLOBE NEWSWIRE) -- Secura Bio, Inc. (www.securabio.com), an integrated pharmaceutical company maximizing commercial outcomes for oncology medicines, today announced a poster presentation highlighting extended follow up analyses examining additional safety data and impact of prior lines of therapy from the Company’s Phase 2 PRIMO trial at the upcoming 2025 American Society of Hematology (ASH) Annual Meeting taking place on December 6-9, 2025 in Orlando, Florida. The PRIMO trial evaluated the investigational use of duvelisib as a single agent for the treatment of relapsed/refractory (R/R) peripheral T-cell lymphoma (PTCL). The poster, entitled Duvelisib in patients with relapsed/refractory peripheral T-cell lymphoma: Final results from the phase 2 PRIMO trial - impact of prior therapy and expanded safety analysis, will be presented by Dr. Pier Luigi Zinzani, University of Bologna, on Sunday, December 7, 2025, from 6:00 PM to 8:00 PM (EST) in the Orange County Convention Center, West Halls B3-B4. The abstract is available here. Secura Bio, Inc. also presented results of the PRIMO trial at ASH in 2024. The PRIMO clinical trial was a global, multicenter, open-label, single-arm trial sponsored by Secura Bio, Inc., that evaluated COPIKTRA for the treatment of adult patients with R/R PTCL. Based on the dose optimization phase results, an expansion group of 123 patients was added in which duvelisib was dosed at 75 mg twice daily for two cycles, followed by 25 mg twice daily. Duvelisib will also be highlighted in other presentations, including: Dr. Hunter Cochran, Washington University School of Medicine, Washington University in St. Louis, will be presenting a poster entitled Favorable safety and efficacy in a phase II trial using duvelisib maintenance after autologous stem cell transplant in T-cell and B-cell non-Hodgkin lymphomas on Saturday, December 6, 2025, from 5:30 PM – 7:30 PM (EST) in the Orange County Convention Center, West Halls B3-B4Dr. Michael Slade, Washington University School of Medicine, Washington University in St. Louis, will be presenting an oral presentation entitled Primary analysis of Phase 1B trial of duvelisib for cytokine release syndrome prophylaxis in patients undergoing chimeric antigen receptor T-cell therapy for non-Hodgkin lymphoma on Monday, December 8, 2025, from 3:45 PM – 4:00 PM (EST) in the Orange County Convention Center, Sunburst Room (W340) About Peripheral T-cell LymphomaPeripheral T-cell lymphoma (PTCL) is a rare, aggressive type of non-Hodgkin lymphoma that develops in mature white blood cells that circulate through the bloodstream and lymphatic system. PTCL accounts for between 10-15% of all non-Hodgkin lymphomas and generally affects people aged 60 years and older. Although there are many different subtypes of PTCL, they often present in a similar way, with widespread, enlarged, typically painless lymph nodes in the neck, armpit, and/or groin. There are currently no well-established standards of care for patients with relapsed or refractory disease. About COPIKTRA (duvelisib)COPIKTRA (duvelisib) is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first US approved dual inhibitor of PI3K-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant cells. PI3K signaling may lead to the proliferation of malignant cells and is thought to play a role in the formation and maintenance of a supportive tumor microenvironment. INDICATIONS AND USAGECOPIKTRA is a kinase inhibitor indicated for the treatment of adult patients with:Relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior lines of systemic therapy. Limitations of Use: COPIKTRA is not indicated or recommended for the treatment of any patients with CLL or SLL as initial or second line treatment due to an increased risk of treatment-related mortality. IMPORTANT SAFETY INFORMATION ABOUT COPIKTRA WARNING: FATAL AND SERIOUS TOXICITIES: INFECTIONS, DIARRHEA OR COLITIS, CUTANEOUS REACTIONS, and PNEUMONITIS See full prescribing information for complete boxed warning Fatal and/or serious infections occurred in 31% (4% fatal) of COPIKTRA-treated patients. Monitor for signs and symptoms of infection. Withhold COPIKTRA if infection is suspected.Fatal and/or serious diarrhea or colitis occurred in 18% (<1% fatal) of COPIKTRA-treated patients. Monitor for the development of severe diarrhea or colitis. Withhold COPIKTRA.Fatal and/or serious cutaneous reactions occurred in 5% (<1% fatal) of COPIKTRA-treated patients. Withhold COPIKTRA.Fatal and/or serious pneumonitis occurred in 5% (<1% fatal) of COPIKTRA-treated patients. Monitor for pulmonary symptoms and interstitial infiltrates. Withhold COPIKTRA. WARNINGS AND PRECAUTIONS Hepatotoxicity: Monitor hepatic function.Neutropenia: Monitor blood counts.Embryo-Fetal toxicity: COPIKTRA can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception. ADVERSE REACTIONSThe most common adverse reactions (≥20%) are diarrhea or colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper respiratory infection, pneumonia, musculoskeletal pain, and anemia.DRUG INTERACTIONS CYP3A inducers: Avoid co-administration with strong or moderate CYP3A inducers.CYP3A inhibitors: Monitor for COPIKTRA toxicities when co-administered with strong or moderate CYP3A inhibitors. Reduce COPIKTRA dose to 15 mg twice daily when co-administered with strong CYP3A4 inhibitors.CYP3A substrates: Monitor for signs of toxicities when co-administering COPIKTRA with sensitive CYP3A substrates. USE IN SPECIFIC POPULATIONSLactation: Advise women not to breastfeed. Please click here to see full Prescribing Information, including Boxed WARNING, for COPIKTRA (duvelisib). About Secura Bio, Inc.Secura Bio, Inc. is an integrated, commercial-stage pharmaceutical company dedicated to the worldwide development and commercialization of impactful oncology therapies for physicians and their patients. For more information on Secura Bio, please visit https://www.securabio.com/. Investor ContactWill BrownChief Financial OfficerPhone: 619-986-1364ir@securabio.com Media ContactKit RodopheleTen Bridge CommunicationsPhone: 617-999-9620krodophele@tenbridgecommunications.com

Clinical ResultPhase 2Cell TherapyASHPhase 1

100 Deals associated with Duvelisib hydrate

External Link

KEGG	Wiki	ATC	Drug Bank
D10555 D11658	Duvelisib hydrate	L01XE	DB11952

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Chronic Lymphocytic Leukemia	United States	Secura Bio, Inc.	24 Sep 2018
Follicular Lymphoma	United States	Secura Bio, Inc.	24 Sep 2018
Small Lymphocytic Lymphoma	United States	Secura Bio, Inc.	24 Sep 2018

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
T-cell lymphoma recurrent	Phase 3	Belgium	Secura Bio, Inc.	19 May 2025
T-cell lymphoma recurrent	Phase 3	Czechia	Secura Bio, Inc.	19 May 2025
T-cell lymphoma recurrent	Phase 3	Denmark	Secura Bio, Inc.	19 May 2025
T-cell lymphoma recurrent	Phase 3	France	Secura Bio, Inc.	19 May 2025
T-cell lymphoma recurrent	Phase 3	Germany	Secura Bio, Inc.	19 May 2025
T-cell lymphoma recurrent	Phase 3	Italy	Secura Bio, Inc.	19 May 2025
T-cell lymphoma recurrent	Phase 3	Netherlands	Secura Bio, Inc.	19 May 2025
T-cell lymphoma recurrent	Phase 3	Poland	Secura Bio, Inc.	19 May 2025
T-cell lymphoma recurrent	Phase 3	Spain	Secura Bio, Inc.	19 May 2025
T-cell lymphoma recurrent	Phase 3	United Kingdom	Secura Bio, Inc.	19 May 2025

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05044039 (ASH2025)	Phase 1	Non-Hodgkin Lymphoma	42	duvelisib (Dose Escalation (DE) cohort)	yoakwqcuvx(qxjvxbhsep) = muhqwsmhax gcllanjcuy (mvavejitvb ) View more	Positive	06 Dec 2025
NCT05044039 (ASH2025)	Phase 1	Non-Hodgkin Lymphoma	42	duvelisib (Standard dosing (SD) cohort)	vclzfkghuc(natnovhpld) = fvuretyiic vxcyqaprug (kaockwqbqg ) View more	Positive	06 Dec 2025
NCT03372057 (PRIMO, ASH2025)	Phase 2	Peripheral T-Cell Lymphoma	123	Duvelisib monotherapy (75 mg BID for 2 cycles, then 25 mg BID)	epcjmqtzyg(vdfxdzcxcz) = foqkmpkkah qmdncmyicq (mbneanxded ) View more	Positive	06 Dec 2025
NCT03372057 (PRIMO, ASH2025)	Phase 2	Peripheral T-Cell Lymphoma	123	Duvelisib monotherapy (75 mg BID for 2 cycles, then 25 mg BID) (Prior CHOP-based therapy)	epcjmqtzyg(vdfxdzcxcz) = ttqynxpcuq qmdncmyicq (mbneanxded ) View more	Positive	06 Dec 2025
ASH2025	Phase 2	Maintenance	17	Duvelisib	nmnuunocxj(lnpbcvybkc) = Grade 3 treatment-related AEs were observed in 9 patients, including febrile neutropenia (n = 1), lymphopenia (n = 3), diarrhea (n = 1), pneumonia (n = 1), and elevated liver enzymes (n = 3) xhgfbbrulw (qljbywzufy ) View more	Positive	06 Dec 2025
NCT05976997 (ASH2025)	Phase 2	Immunoblastic Lymphadenopathy First line	12	Duvelisib + Chidamide + CHOP chemotherapy	edjxshckgm(qrfrlmoukw) = mainly hematological toxicity, including leucopenia (41.7%)and neutropenia (41.7%), as well as infections including lung infections 33.3% axjbwtokam (fcecnaxbdp ) View more	Positive	06 Dec 2025
NCT06522737 (TERZO, EHA2025)	Phase 3	Recurrent Nodal Peripheral T-Cell Lymphoma with TFH Phenotype AITL score	124	Duvelisib 75 mg	xyjclniiog(mhyouoebdw) = xbdaamgdwj jlbuzaklqs (ddegcoewuj ) View more	Positive	14 May 2025
NCT05057247 (BURAN, CTgov)	Phase 2	Advanced Head and Neck Squamous Cell Carcinoma \| Recurrent Squamous Cell Carcinoma of the Head and Neck \| Head and neck cancer metastatic	26	Duvelisib+Docetaxel	iajfzarwqn = xvihnftcum syubwotkbq (owskbojedf, lkbpyqcvii - szndwfhvgm) View more	-	05 Mar 2025
NCT03372057 (PRIMO, CTgov)	Phase 2	Peripheral T-Cell Lymphoma	156	Duvelisib (Dose Optimization Phase: Cohort 1)	jplapuxyqp = mplrhelufz apaahmzjxg (pnnamxathh, qdjgtcikrd - slinhxsyos) View more	-	28 Feb 2025
NCT03372057 (PRIMO, CTgov)	Phase 2	Peripheral T-Cell Lymphoma	156	Duvelisib (Dose Optimization Phase: Cohort 2)	jplapuxyqp = fwhzksaeww apaahmzjxg (pnnamxathh, fbyolllzbu - liblihxens) View more	-	28 Feb 2025
ASH2024	Not Applicable	Peripheral T-Cell Lymphoma	-	Duvelisib 75 mg BID + Romidepsin 10 mg/m2	ggmbdxflar(ephzsyjuwm) = anemia (n=3) zuwzozeozd (hazhizazvo ) View more	-	09 Dec 2024
ASH2024 Manual	Phase 1	T-Cell Lymphoma	49	Ruxolitinib 20mg BID + Duvelisib 25mg BID	crhqccpzvf(tbcqjwgxbn) = jelcwtjayf mkxczqcajm (sklwgpefcj ) View more	Positive	08 Dec 2024
3065A (ASH2024)	Phase 1	Peripheral T-Cell Lymphoma	14	Duvelisib 25 mg	lcmtlxqkwj(aogklaulve) = qxmwdvhkbq xzanpfijzl (arlrrybkfs, 6.3 - NE) View more	Positive	08 Dec 2024
3065A (ASH2024)	Phase 1	Peripheral T-Cell Lymphoma	14	Duvelisib 50 mg	lcmtlxqkwj(aogklaulve) = gktjtopxnl xzanpfijzl (arlrrybkfs, 6.3 - NE) View more	Positive	08 Dec 2024

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