Copiktra (duvelisib) / Verastem, CSPC Pharma, Secura Bio, Sanofi, Yakult Honsha - LARVOL DELTA

A phase I/II Study of Duvelisib plus Venetoclax in Patients with Relapsed/Refractory CLL/SLL or Richter Transformation. (PubMed, Blood Adv) - P1/2 | "Overall, duvelisib plus venetoclax was active in high-risk R/R CLL/SLL and RT, though serious adverse events occurred, including immune-mediated toxicities. NCT03534323."

Journal • P1/2 data • Chronic Lymphocytic Leukemia • Febrile Neutropenia • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Richter's Syndrome • Small Lymphocytic Lymphoma • IGH • TP53

Cost-Effectiveness Analysis of PI3K Inhibitors for Relapsed or Refractory Follicular Lymphoma in China: A Comparison Between Linperlisib and Duvelisib. (PubMed, Clin Drug Investig) - P2 | "Linperlisib is cost effective compared to duvelisib for 3L+ FL patients in China, as verified in sensitivity analyses. Further study is warranted to confirm that it meets an unmet need in China."

HEOR • Journal • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology

Cutaneous and Systemic Complications in Primary CD8+ Aggressive Epidermotropic Cytotoxic T-cell Lymphoma. (PubMed, Cureus) - "We present the case of a 61-year-old man with CD8+ AECTCL who developed a methicillin-sensitive Staphylococcus aureus port-site infection while on duvelisib following prior gemcitabine/liposomal doxorubicin therapy...Complement studies supported the activation of the alternative pathway, and after multidisciplinary discussion, eculizumab was initiated for TMA management...His cutaneous lymphoma lesions improved with a short course of oral prednisone as directed by oncology. At discharge, he was clinically stable on dialysis with plans for ongoing outpatient care; subsequent follow-up showed stable renal function. This case highlights the intersection between aggressive cutaneous lymphoma, infection, and chemotherapy-induced vascular injury, emphasizing the importance of early recognition of systemic complications in CD8+ AECTCL and the need for a multidisciplinary approach to optimize patient outcomes."

Journal • Acute Kidney Injury • Cutaneous T-cell Lymphoma • Dermatology • Diabetic Nephropathy • Hematological Malignancies • Infectious Disease • Lymphoma • Nephrology • Oncology • Pain • Renal Disease • Septic Shock • T Cell Non-Hodgkin Lymphoma • CD8

Duvelisib in patients with relapsed/refractory peripheral T-cell lymphoma from the phase 2 PRIMO Trial Expansion Phase: outcomes by baseline histology (ICML 2023) - P2 | "Except for brentuximab vedotin in CD30-positive disease, agents were generally approved based on overall response rates (ORR) of less than 30%. The ORR (by IRC) of DUV was higher in pts with PTCL-NOS (48%) and AITL (67%), compared with ALCL (13%). This corresponded to a longer median PFS of 3.5 mo in PTCL-NOS and 9.1 mo in AITL compared with 1.5 mo in ALCL. Although not powered for subset analyses, this analysis suggests activity of DUV may not be uniform across different types of lymphomas."

Clinical • P2 data • Hematological Malignancies • Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • CD4 • PIK3CG • TNFRSF8

Ford JG, Koh MJ, Lenart AW, et al. Real-world evidence of duvelisib and romidepsin in relapsed/refractory peripheral and cutaneous T-cell lymphomas. Blood Adv. 2025;9(16):4286-4305. (PubMed, Blood Adv) - No abstract available

HEOR • Journal • Real-world evidence • Cutaneous T-cell Lymphoma • Hematological Malignancies • Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

DUVELISIB IN PATIENTS WITH RELAPSED/REFRACTORY PERIPHERAL T-CELL LYMPHOMA FROM THE PHASE 2 PRIMO TRIAL EXPANSION PHASE: OUTCOMES BY BASELINE HISTOLOGY (EHA 2023) - P2 | "With the exception of brentuximab vedotin (BV) in CD30-positive disease, these agents were generally approved based on overall response rates (ORR) of less than 30%. The ORR (by IRC) of duvelisib was higher in patients with PTCL-NOS (48%) and AITL (67%), compared with ALCL (13%). This corresponded to a longer median PFS of 3.5 mo in PTCL-NOS and 9.1 mo in AITL compared with 1.5 mo in ALCL. Although not powered for subset analyses, this analysis suggests activity of duvelisib may not be uniform across different types of lymphomas."

Clinical • P2 data • Hematological Malignancies • Herpes Simplex • Herpes Zoster • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • Varicella Zoster • CD4 • PIK3CG • TNFRSF8

High Rates of Remission with the Initial Treatment of Oral Azacitidine Plus CHOP for Peripheral T-Cell Lymphoma (PTCL): Clinical Outcomes and Biomarker Analysis of a Multi-Center Phase II Study (ASH 2021) - P2 | "This study demonstrates that priming with oral azacitidine (CC486) in combination with CHOP as initial therapy is safe, effective, and produces sustained remission in PTCL-TFH subtype. Epigenetic priming with azacitidine appears to inhibit the proliferation of TFH lymphoma cells, providing potential synergistic mechanism of action with chemotherapy. This active combination will be further evaluated in the upcoming ALLIANCE/ US Intergroup randomized study A051902, comparing oral azacitidine-CHO(E)P vs duvelisib-CHO(E)P against CHO(E)P in CD30 negative PTCL."

Biomarker • Clinical • Clinical data • P2 data • Anemia • Anorexia • Bone Marrow Transplantation • Cardiovascular • Fatigue • Febrile Neutropenia • Heart Failure • Hematological Malignancies • Immunology • Inflammation • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • Thrombocytopenia • Transplantation • DNMT3A • IDH2 • RHOA • TET2 • TNFRSF8 • TRB

Duvelisib plus romidepsin in relapsed/refractory T cell lymphomas: a phase 1b/2a trial. (PubMed, Nat Med) - P1 | "As reported here, we conducted a phase 1b/2a study of duvelisib in combination with either romidepsin (n = 66) or bortezomib (n = 32) in patients with relapsed/refractory TCL and found that the addition of romidepsin, but not bortezomib, appeared to increase efficacy while attenuating PI3K inhibitor-driven toxicity. These findings support further development of combined PI3K and histone deacetylase (HDAC) inhibition in TCLs and suggest a unique strategy to enable PI3K inhibitor-based combinations for additional patient populations. ClinicalTrials.gov identifier: NCT02783625 ."

Journal • P1/2 data • Fatigue • Hematological Disorders • Hematological Malignancies • Hepatology • Immunology • Lymphoma • Neutropenia • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

Estimation of the metabolic stability of omipalisib in human liver microsomes employing an ultra-fast UPLC-MS/MS approach: in silico screening for structural alarms and metabolic lability. (PubMed, Anal Methods) - "OMP and duvelisib (internal standard) were evaluated using an SB-C18 column. In silico analysis indicates that slight structural modifications to the methoxy group or the pyridazine ring in the process of drug design may increase the safety profile and metabolic stability of new derivatives compared with those of OMP. The integrated in vitro/in silico approach provides a resource-efficient strategy for preliminary metabolic screening and advancing new therapeutic developments aimed at enhancing metabolic stability."

Journal • Oncology

Human Serum Albumin-Lipid Nanocapsules of Duvelisib for Hematological Cancers: Characterization, In-Vitro Cell-Culture, Toxicity and Pharmacokinetic Studies. (PubMed, AAPS PharmSciTech) - "The DUV-NCs were found to be safe in toxicity studies with no major alterations in biomarkers compared to the control. In conclusion, DUV-NCs is a promising strategy to deliver DUV in hematological malignancies with improved efficacy and safety."

Journal • PK/PD data • Preclinical • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Oncology • PIK3CG

Intermittent Duvelisib Dosing in Treating Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (clinicaltrials.gov) - P2 | N=15 | Active, not recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Nov 2025 ➔ Oct 2026

Trial completion date • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma • BCL2 • CCND1 • FCER2

Duvelisib Maintenance After Autologous Stem Cell Transplant in T-Cell Lymphomas (clinicaltrials.gov) - P2 | N=17 | Active, not recruiting | Sponsor: Washington University School of Medicine | Trial completion date: Dec 2025 ➔ Apr 2026 | Trial primary completion date: Dec 2025 ➔ Apr 2026

Trial completion date • Trial primary completion date • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma • Transplantation

Duvelisib and Nivolumab for the Treatment of Stage IIB-IVB Mycosis Fungoides and Sezary Syndrome (clinicaltrials.gov) - P1 | N=38 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Nov 2027 ➔ Dec 2026 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Cutaneous T-cell Lymphoma • Dermatology • Lymphoma • Mycosis Fungoides • Non-Hodgkin’s Lymphoma • Oncology • Sezary Syndrome

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines), the NCCN Drugs & Biologics Compendium (NCCN Compendium), the NCCN Radiation Therapy Compendium, and the NCCN Imaging Appropriate Use Criteria (NCCN Imaging AUC) for Cutaneous Lymphomas, Version 1.2026. (NCCN)

NCCN guideline • Cutaneous T-cell Lymphoma

Secura Bio, Inc…provided...an update on the encouraging enrollment progress in its ongoing Phase 3 TERZO study of COPIKTRA (duvelisib) in adults with relapsed or refractory (R/R) nodal T-follicular helper cell lymphoma (nTFHL). (GlobeNewswire) - "To date, the study has randomized 35 of the anticipated 124 patients and has activated 43 of the expected 45 sites across ten European countries. The Company initiated the study earlier this year, with the first patient dosed in June...Having achieved 25% patient accrual already, the study is advancing at the top end of our expectations and keeps us on track for an interim data readout in early 2027."

P3 data • Trial status • Extranodal Natural Killer/T-cell Lymphoma • Follicular T-cell Lymphoma

Additional 2025 Corporate Highlights: (GlobeNewswire) - "Achieved >30% year-over-year annual growth in U.S. net sales of COPIKTRA year to date through November"

Sales • Follicular Lymphoma • Hematological Malignancies • Non-Hodgkin’s Lymphoma

Representation of Older Adults in Registrational Trials Associated with Therapeutic Approvals in Follicular Lymphoma (SIOG 2025) - "FL trials had low OA enrolment, with inadequate reporting and participation of adults over 75 yrs. Enhanced age subgroup reporting and OA enrolment are needed to ensure that trial outcomes are more representative of the broader patient population, particularly the elderly, who are most affected by FL."

Clinical • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology

Representation of Older Adults in Registrational Trials Associated with Therapeutic Approvals in Follicular Lymphoma (SIOG 2025) - "FL trials had low OA enrolment, with inadequate reporting and participation of adults over 75 yrs. Enhanced age subgroup reporting and OA enrolment are needed to ensure that trial outcomes are more representative of the broader patient population, particularly the elderly, who are most affected by FL."

Clinical • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology

Representation of Older Adults in Registrational Trials Associated with Therapeutic Approvals in Follicular Lymphoma (SIOG 2025) - "FL trials had low OA enrolment, with inadequate reporting and participation of adults over 75 yrs. Enhanced age subgroup reporting and OA enrolment are needed to ensure that trial outcomes are more representative of the broader patient population, particularly the elderly, who are most affected by FL."

Clinical • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology

Representation of Older Adults in Registrational Trials Associated with Therapeutic Approvals in Follicular Lymphoma (SIOG 2025) - "FL trials had low OA enrolment, with inadequate reporting and participation of adults over 75 yrs. Enhanced age subgroup reporting and OA enrolment are needed to ensure that trial outcomes are more representative of the broader patient population, particularly the elderly, who are most affected by FL."

Clinical • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology

Representation of older adults in registrational trials associated with therapeutic approvals in follicular lymphoma (ASH 2025) - "Of the drugs approved, 2 were bispecific antibodies (BsAb,epcoritamab, mosunetuzumab), 3 were chimeric antigen receptor-T (CAR-T) products (lisocabtagene,axicabtagene, tisagenleucel), 3 were PI3K inhibitors (umbralisib, copanlisib, duvelisib), 2 were monoclonalantibodies (obinutuzumab with chemotherapy, obinutuzumab with bendamustine), and 1 each ofselective EZH2 inhibitor (tazemetostat), immunomodulator (lenalidomide with rituximab), and BTKinhibitor (zanubrutinib). Most registrational trials for FL do report a subgroup of OA, although inclusion of OAremains suboptimal at 37%. Representation and reporting of pts≥ 75 yrs is significantly low at only 8%,despite this group representing 20% pts at diagnosis. Reporting of trials should include and distinguishpts ≥65 yrs and ≥75 yrs for subgroup analyses."

Clinical • Follicular Lymphoma • Geriatric Disorders • Hematological Malignancies • Lymphoma

Duvelisib Maintenance for the Treatment of Peripheral T-Cell Lymphomas (clinicaltrials.gov) - P2 | N=25 | Not yet recruiting | Sponsor: City of Hope Medical Center

New P2 trial • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

Characterization of pityriasis rubra pilaris with hematological malignancies: Paraneoplastic disease and targeted therapy reactions (ASH 2025) - "The ALL patient was related to ponatinib, the non-Hodgkin's lymphoma case was related to copanlisib, 2 CLL patients were related to duvelisib, and 2 CLL were related to idealisib...With regards to paraneoplastic treatment, topical treatment included corticosteroids, emollients, topical urea, retinoids, and fluorouracil. Systemic treatments included methotrexate, systemic corticosteroids, and phototherapy...Specialists should maintain a high index of suspicion for PRP as a paraneoplastic signal or drug-related adverse event. Future studies are needed to elucidate such presentations and guide management."

Chronic Lymphocytic Leukemia • Dermatology • Dermatopathology • Hematological Malignancies • Immunology • Infectious Disease • Leukemia • Lymphoma • Multiple Myeloma • Myelodysplastic Syndrome • Non-Hodgkin’s Lymphoma • Oncology

Financial Toxicity and Quality of Life in Patients Taking Oral Therapy for Hematologic Malignancies (ASH 2023) - "MethodsWe used database query to identify patients at a midwestern, tertiary care, academic medical center who were 18 years or older and were prescribed Enasidenib, Ivosidenib, Venetoclax, Gilteritinib, Midostaurin, Ibrutinib, Acalabrutinib, Imatinib, Nilotinib, Ponatinib, Bosutinib, Duvelisib, or Idelalisib within the past 3 months. Financial stress and hardship were associated with worse satisfaction with QoL and worse experience of SE. Further study should define change in these features over time and interventions to mitigate distress."

Clinical • HEOR • Acute Myelogenous Leukemia • Chronic Lymphocytic Leukemia • CNS Disorders • Depression • Hematological Malignancies • Mood Disorders • Oncology • Oral Cancer • Psychiatry

Duvelisib in Combination With Nivolumab in Patients With Advanced Unresectable Melanoma (clinicaltrials.gov) - P1/2 | N=13 | Terminated | Sponsor: John Kirkwood | Trial completion date: Dec 2028 ➔ Feb 2025 | Active, not recruiting ➔ Terminated; Secura Bio, Inc. discontinued support of the trial.

Trial completion date • Trial termination • Melanoma • Oncology • Solid Tumor • BRAF