^
    4d
    Evaluation of the Role of AID-Induced Mutagenesis in Resistance to B-Cell Receptor Pathway Inhibitors in Chronic Lymphocytic Leukemia. (PubMed, Curr Issues Mol Biol)
    Chronic lymphocytic leukemia (CLL) is the most common leukemia in Western countries, and B-cell receptor (BCR) pathway inhibitors such as idelalisib and ibrutinib are currently established therapies for CLL. We conclude that BCR pathway inhibitors enhance AID mutational activity in CLL, but this does not appear to be directly involved in driving drug resistance. AID-targeted loci may nonetheless serve as biomarkers for monitoring genomic instability during treatment and inform further study.
    Journal • IO biomarker
    |
    BCL2 (B-cell CLL/lymphoma 2) • IRF8 (Interferon Regulatory Factor 8)
    |
    Imbruvica (ibrutinib) • Zydelig (idelalisib)
    4d
    topMIND: A Study Evaluating Safety, PK, and Efficacy of Tafasitamab and Parsaclisib in Participants With Relapsed/Refractory Non Hodgkin Lymphoma (R/R NHL) or Chronic Lymphocytic Leukemia (CLL) (clinicaltrials.gov)
    P1/2, N=54, Terminated, Incyte Corporation | Completed --> Terminated; A business decision was made to discontinue further enrollment. There were no safety concerns that contributed to this decision.
    Trial termination • Pan tumor
    |
    BCL2 (B-cell CLL/lymphoma 2) • CCND1 (Cyclin D1) • BCL6 (B-cell CLL/lymphoma 6)
    |
    Chr t(11;14)
    |
    parsaclisib (INCB50465) • Monjuvi (tafasitamab-cxix)
    5d
    A Study of Bosmolisib (BR101801) in Participants With R/R PTCL. (clinicaltrials.gov)
    P2, N=44, Not yet recruiting, Boryung Pharmaceutical Co., Ltd | Initiation date: Sep 2025 --> Feb 2026
    Trial initiation date
    |
    bosmolisib (BR101801)
    10d
    SWOG S1608: Obinutuzumab With or Without Umbralisib, Lenalidomide, or Combination Chemotherapy in Treating Patients With Relapsed or Refractory Grade I-IIIa Follicular Lymphoma (clinicaltrials.gov)
    P2, N=73, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2025 --> Jan 2027
    Trial completion date
    |
    CD4 (CD4 Molecule)
    |
    lenalidomide • doxorubicin hydrochloride • Gazyva (obinutuzumab) • cyclophosphamide • vincristine • Ukoniq (umbralisib) • Belrapzo (bendamustine RTD)
    12d
    The PI3Kδ inhibitor roginolisib (IOA-244) preserves T-cell function and activity. (PubMed, Mol Oncol)
    Furthermore, idelalisib treatment promoted differentiation of conventional CD4+ T cells into Th1, Th2, and Th17 subsets-a response not observed with roginolisib. In summary, roginolisib functions as an effective PI3K inhibitor on leukemic cells while preserving T-cell functions, posing it as an alternative to current PI3K inhibitors.
    Journal
    |
    CD8 (cluster of differentiation 8) • PIK3CD (Phosphatidylinositol-4 5-Bisphosphate 3-Kinase Catalytic Subunit Delta) • CD4 (CD4 Molecule)
    |
    Zydelig (idelalisib) • roginolisib (IOA-244)
    12d
    Clinical efficacy and safety of umbralisib, a dual PI3Kδ/CK1-ϵ inhibitor, in treatment of hematologic malignancies. (PubMed, Front Oncol)
    Further studies are needed to optimize combination strategies, explore alternative administration routes, and refine dosing approaches. https://www.crd.york.ac.uk/PROSPERO/, identifier CRD420251018098.
    Review • Journal
    |
    PIK3CD (Phosphatidylinositol-4 5-Bisphosphate 3-Kinase Catalytic Subunit Delta)
    |
    Ukoniq (umbralisib)
    17d
    OCULE-01: A Randomised Phase II Study of Roginolisib in Patients With Advanced/Metastatic Uveal Melanoma (clinicaltrials.gov)
    P2, N=85, Active, not recruiting, iOnctura | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    roginolisib (IOA-244)
    17d
    PULMO-01: A Study of Roginolisib (IOA-244) in Combination With Dostarlimab With or Without Docetaxel in Metastatic Non Small-cell Lung Cancer (NSCLC) Patients (clinicaltrials.gov)
    P1/2, N=45, Active, not recruiting, iOnctura | Recruiting --> Active, not recruiting
    Enrollment closed • IO biomarker
    |
    IL7R (Interleukin 7 Receptor)
    |
    docetaxel • Jemperli (dostarlimab-gxly) • roginolisib (IOA-244)
    18d
    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.
    PK/PD data • Preclinical • Journal
    |
    PIK3CG (Phosphatidylinositol-4,5-Bisphosphate 3-Kinase Catalytic Subunit Gamma)
    |
    Copiktra (duvelisib)
    24d
    Phase 2 Study of PI3K Inhibitor Copanlisib in Combination With Fulvestrant in Selected ER+ and/or PR+ Cancers With PI3K (PIK3CA, PIK3R1) and/or PTEN Alterations (clinicaltrials.gov)
    P2, N=7, Terminated, M.D. Anderson Cancer Center | Trial completion date: Feb 2027 --> Dec 2025 | Active, not recruiting --> Terminated; Copanlisib development was discontinued by Bayer following withdrawal of copanlisib in relapsed follicular lymphoma in November 2023.
    Trial completion date • Trial termination
    |
    PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PGR (Progesterone receptor) • PTEN (Phosphatase and tensin homolog) • PIK3R1 (Phosphoinositide-3-Kinase Regulatory Subunit 1) • PI3K (Phosphoinositide 3-kinases)
    |
    PIK3CA mutation • PTEN deletion
    |
    fulvestrant • Aliqopa (copanlisib)
    26d
    Copanlisib Plus Venetoclax in R/R DLBCL (clinicaltrials.gov)
    P1/2, N=48, Active, not recruiting, Dana-Farber Cancer Institute | Trial completion date: Apr 2026 --> Jul 2026 | Trial primary completion date: Apr 2026 --> Jul 2025
    Trial completion date • Trial primary completion date
    |
    BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6)
    |
    Venclexta (venetoclax) • Aliqopa (copanlisib)
    28d
    Intermittent Duvelisib Dosing in Treating Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (clinicaltrials.gov)
    P2, N=15, Active, not recruiting, City of Hope Medical Center | Trial completion date: Nov 2025 --> Oct 2026
    Trial completion date
    |
    BCL2 (B-cell CLL/lymphoma 2) • CCND1 (Cyclin D1) • FCER2 (Fc Fragment Of IgE Receptor II)
    |
    Chr t(11;14)
    |
    Copiktra (duvelisib) • ETP-47187