^
    2ms
    Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465) (clinicaltrials.gov)
    P2, N=112, Active, not recruiting, Incyte Corporation | Trial completion date: Sep 2027 --> Nov 2026 | Trial primary completion date: Sep 2027 --> Nov 2026
    Trial completion date • Trial primary completion date
    |
    Imbruvica (ibrutinib) • Jakafi (ruxolitinib) • parsaclisib (INCB50465) • itacitinib (INCB039110)
    2ms
    Niraparib and Copanlisib in Treating Patients With Recurrent Endometrial, Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (clinicaltrials.gov)
    P1, N=31, Completed, M.D. Anderson Cancer Center | Active, not recruiting --> Completed | Trial completion date: Dec 2026 --> Jun 2026 | Trial primary completion date: Dec 2026 --> Jun 2026
    Trial completion • Trial completion date • Trial primary completion date
    |
    BRCA (Breast cancer early onset) • MUC16 (Mucin 16, Cell Surface Associated)
    |
    BRCA mutation
    |
    Zejula (niraparib) • Aliqopa (copanlisib)
    2ms
    PI3Kδ inhibitor YY‑20394 is effective alone or in combination with Bcl‑2 inhibitor ABT199 in acute myeloid leukemia cells. (PubMed, Oncol Rep)
    YY‑20394 (linperlisib), a highly specific PI3Kδ inhibitor, has demonstrated promising efficacy in a variety of hematological malignancies in clinical trials. In summary, YY‑20394 is effective for inhibiting proliferation of AML cells, and its combination with ABT199 has synergistic pro‑apoptotic effects in MV‑4‑11 cells, which provides new insights and potential avenues for the treatment of AML and its subtypes. Further studies are warranted to explore the therapeutic efficacy and underlying molecular mechanisms of this combination in additional AML subtypes.
    Journal
    |
    MYC (V-myc avian myelocytomatosis viral oncogene homolog) • BCL2 (B-cell CLL/lymphoma 2) • PIK3CD (Phosphatidylinositol-4 5-Bisphosphate 3-Kinase Catalytic Subunit Delta)
    |
    Venclexta (venetoclax) • Itari (linperlisib)
    2ms
    Combined inhibition of CDK4/6 and PI3K pathways exhibit highly synergistic activity and translational potential in Ewing sarcoma. (PubMed, Transl Oncol)
    The results of the screen revealed that a PI3K inhibitor, copanlisib, combined with a CDK4/6 inhibitor, ribociclib, exhibited strong synergistic anti-Ewing sarcoma activity. In two xenograft models of Ewing sarcoma, we demonstrated that the combination significantly prolonged survival compared to treatment with either vehicle or single-agent therapy alone. Our findings identify a new candidate therapy combination for Ewing sarcoma and provide a resource of additional potential synergistic combinations for future validation.
    Journal
    |
    CDK4 (Cyclin-dependent kinase 4) • EWSR1 (EWS RNA Binding Protein 1) • FLI1 (Fli-1 Proto-Oncogene ETS Transcription Factor)
    |
    Kisqali (ribociclib) • Aliqopa (copanlisib)
    2ms
    Lenalidomide With or Without Idelalisib in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma (clinicaltrials.gov)
    P1, N=106, Completed, Alliance for Clinical Trials in Oncology | Phase classification: P2 --> P1
    Phase classification
    |
    CCND1 (Cyclin D1) • CD4 (CD4 Molecule) • CD5 (CD5 Molecule) • FCER2 (Fc Fragment Of IgE Receptor II)
    |
    lenalidomide • Zydelig (idelalisib)
    2ms
    Pediatric Patients Aged 1 to 6 Years With APDS (clinicaltrials.gov)
    P3, N=16, Active, not recruiting, Pharming Technologies B.V. | Trial completion date: Oct 2026 --> Oct 2028 | Trial primary completion date: Jul 2026 --> Jul 2028
    Trial completion date • Trial primary completion date
    |
    PIK3R1 (Phosphoinositide-3-Kinase Regulatory Subunit 1) • PIK3CD (Phosphatidylinositol-4 5-Bisphosphate 3-Kinase Catalytic Subunit Delta)
    3ms
    Duvelisib Maintenance for the Treatment of Peripheral T-Cell Lymphomas (clinicaltrials.gov)
    P2, N=25, Recruiting, City of Hope Medical Center | Not yet recruiting --> Recruiting
    Enrollment open
    |
    CD4 (CD4 Molecule)
    |
    Copiktra (duvelisib) • ETP-47187
    3ms
    PI3Kδ inhibition alters CD8 T cell differentiation and reprograms the tumor microenvironment following adoptive immunotherapy. (PubMed, J Immunol)
    Mechanistically, CAL-101-treated T cells maintain high expression of stemness-associated genes (Tcf7, Slamf6) while resisting expression of genes associated with terminal exhaustion (Tim3, Mt1/2). These findings reveal the mechanisms behind how PI3Kδ inhibition generates T cells capable of establishing and maintaining an antitumor immune response, suggesting a promising strategy for improving adoptive cell therapy outcomes in solid tumors.
    Journal • IO biomarker
    |
    CD8 (cluster of differentiation 8) • CXCL10 (Chemokine (C-X-C motif) ligand 10) • HAVCR2 (Hepatitis A Virus Cellular Receptor 2) • PIK3CD (Phosphatidylinositol-4 5-Bisphosphate 3-Kinase Catalytic Subunit Delta) • SLAMF6 (SLAM Family Member 6) • CXCR3 (C-X-C Motif Chemokine Receptor 3) • TCF7 (Transcription Factor 7)
    |
    Zydelig (idelalisib)
    3ms
    Testing the Addition of Copanlisib to Eribulin in Metastatic Triple Negative Breast Cancer (clinicaltrials.gov)
    P1/2, N=24, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: May 2026 --> May 2027
    Trial completion date
    |
    ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PGR (Progesterone receptor) • PTEN (Phosphatase and tensin homolog)
    |
    HER-2 amplification • HER-2 negative • PIK3CA mutation • PTEN mutation
    |
    eribulin mesylate • Aliqopa (copanlisib)
    3ms
    Add-on parsaclisib for patients with myelofibrosis and suboptimal response to ruxolitinib: a randomized phase 3 study. (PubMed, Oncologist)
    Study results suggested adding parsaclisib to stable-dose ruxolitinib was unlikely to offer clinically meaningful benefits. Further research is needed on the potential of JAK and PI3K inhibitor-based combination therapy for patients with myelofibrosis.
    Clinical • P3 data • Journal
    |
    PIK3CD (Phosphatidylinositol-4 5-Bisphosphate 3-Kinase Catalytic Subunit Delta)
    |
    Jakafi (ruxolitinib) • parsaclisib (INCB50465)
    3ms
    J-MIND: To Assess the Safety and Tolerability of Tafasitamab Alone or in Combination With Other Drugs in Japanese Participants With Non-Hodgkins Lymphoma (NHL) (clinicaltrials.gov)
    P1/2, N=72, Active, not recruiting, Incyte Biosciences Japan GK | Trial primary completion date: Dec 2026 --> Jul 2025
    Trial primary completion date
    |
    Rituxan (rituximab) • lenalidomide • doxorubicin hydrochloride • cyclophosphamide • parsaclisib (INCB50465) • Monjuvi (tafasitamab-cxix)
    3ms
    Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies (clinicaltrials.gov)
    P1, N=121, Completed, Incyte Corporation | Active, not recruiting --> Completed
    Trial completion
    |
    itacitinib (INCB039110) • dezapelisib (INCB040093)