Itari (linperlisib) / Shanghai YingLi Pharma, Jiangsu Hengrui Pharma - LARVOL DELTA

Synergistic Anti-Tumor Effect of Chidamide and Linperlisib on Natural Killer/T-Cell Lymphoma by Inhibiting PI3K/AKT/mTOR Pathway. (PubMed, Hematol Oncol) - "These findings were confirmed in the YT xenograft model. In conclusion, the combination of chidamide and linperlisib has synergistic anti-tumor effects on NKTCL, which are mediated through inhibition of the PI3K/AKT/mTOR pathway, suggesting a promising therapeutic strategy for NKTCL management."

Journal • Hematological Malignancies • Lymphoma • Natural Killer/T-cell Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • PRDM1

Linch: Linperlisib in Combination With CHOP in Previously Untreated Peripheral T-Cell Lymphoma (clinicaltrials.gov) - P1/2 | N=44 | Active, not recruiting | Sponsor: Sun Yat-sen University | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2026 ➔ Dec 2028

Enrollment closed • Trial completion date • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

LINPERLISIB PLUS CHOP FOR NEWLY DIAGNOSED PERIPHERAL T-CELL LYMPHOMA: A SINGLE-ARM, OPEN-LABLE, MULTI-CENTER PHASE IB/II STUDY (LINCH TRIAL) (ICML 2025) - P1/2 | "Preliminary results from LINCH study suggest that linperlisib combined with CHOP as first-line treatment for PTCL achieved promising efficacy and manageable safety, supporting further investigation in larger population."

Clinical • P1/2 data • Hematological Malignancies • Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • PIK3CD

Linperlisib enhances MUC1-Tn CAR T cell efficacy by inhibiting EGR1/DUSP2 axis to prevent CAR T cell exhaustion. (PubMed, Leukemia) - "Furthermore, linperlisib induced mitochondrial fusion and enhanced respiratory capacity in CAR T cells. Mechanistically, this enhanced persistence was attributed to linperlisib-mediated suppression of Dual Specificity Phosphatase 2 (DUSP2) and its upstream transcription factor Early Growth Response 1 (EGR1)."

Journal • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • T Acute Lymphoblastic Leukemia • T-cell Acute Lymphoblastic Lymphoma • DUSP2 • EGR1 • MUC1 • PIK3CD

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 • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology • BCL2 • MYC • PIK3CD

GENOMIC SIGNATURES GUIDED COMBINATION THERAPY OF TAZEMETOSTAT PLUS LINPERLISIB OR GOLIDOCITINIB IN RELAPSED AND REFRACTORY PERIPHERAL T-CELL LYMPHOMA PATIENTS (EHA 2026) - "A phase 2 study showed Tazemetostat (EZH2 inhibitor) plus Amdizalisib (PI3K inhibitors) achieved objective response rate (ORR) 60.7% in R/R PTCL, remarkably with 100% complete response rate(CRR) in 5 patients with TET2/RHOA co-mutations 1 . Based on preliminary efficacy results, this study may increase the sample size for further exploration later. Summary/Conclusion ."

Clinical • Combination therapy • Hematological Malignancies • Lymphoma • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • EZH2 • RHOA • TET2

LINPERLISIB PLUS CHOP FOR NEWLY DIAGNOSED PERIPHERAL T-CELL LYMPHOMA: A SINGLE-ARM, PHASE IB/II STUDY (LINCH TRIAL) (EHA 2026) - P1/2, P2/3 | "C C haracteristics Patients (n=44) Age, years (median [IQR]) 57 (18-77) S S ex ex Male Female 28 (63.6%) 16 (36.4%) ECOG PS 0-1 2 39 (88.6%) 5 (11.4%) Lugano stage I-II III-IV 9 (20.5%) 35 (79.5%) Pathological types AITL PTCL-NOS ALCL TFHL-NOS MEITL SPTCL 23 (52.3%) 14 (31.8%) 3 (6.8%) 2 (4.5%) 1 (2.3%) Summary/Conclusion Preliminary results from LINCH study suggest that linperlisib combined with CHOP as first-line treatment for PTCL achieved promising efficacy and manageable safety. A randomized controlled trial evaluating linperlisib plus CHOP versus CHOP in patients with newly diagnosed PTCL has been initiated (NCT06548347)."

P1/2 data • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukopenia • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Peripheral T-cell Lymphoma • Pneumonia • Respiratory Diseases • T Cell Non-Hodgkin Lymphoma

PRELIMINARY EFFICACY AND SAFETY OF GOLIDOCITINIB IN RELAPSED/REFRACTORY T CELL AND NK CELL LARGE GRANULAR LYMPHOCYTE LEUKEMIA (EHA 2026) - P2 | "Immunosuppressive therapy remains the standard first line treatment, including methotrexate, cyclosporine A, and cyclophosphamide...Sixteen patients had failed three or more prior lines including PI3K δ inhibitor linperlisib and JAK1/2 inhibitor ruxolitinib...Summary/Conclusion Golidocitinib monotherapy has potent antitumor activity in heavily pretreated R/R T/NK-LGLL patients, with 86.1% ORR and 61.1% CRR. Most patients with baseline hematologic abnormalities had marked hematologic improvements, and its favorable safety profile supports further study in this unmet-need population."

Clinical • Autoimmune Hemolytic Anemia • Cutaneous T-cell Lymphoma • Hematological Malignancies • Immunology • Indolent Lymphoma • Infectious Disease • Leukemia • Leukopenia • Lymphoma • Natural Killer/T-cell Lymphoma • Neutropenia • Peripheral T-cell Lymphoma • Respiratory Diseases • T Cell Non-Hodgkin Lymphoma • Thrombocytopenia • STAT3

SYNERGISTIC TARGETING OF JAK-STAT AND PI3K PATHWAYS BY GOLIDOCITINIB AND LINPERLISIB IN T-ALL/LBL: INVOLVEMENT OF RAG1/2 REGULATION (EHA 2026) - "Based on this dual modulation of the TP53 and PI3K-AKT signaling axes, a "pro-apoptotic and anti-survival" strategy is established, offering a promising therapeutic avenue for T-ALL/LBL. Ongoing validation in patient-derived xenograft (PDX) models will support its clinical translation."

IO biomarker • Acute Lymphocytic Leukemia • Lymphoblastic Lymphoma • T Acute Lymphoblastic Leukemia • ANXA5 • BAX • BCL2 • CASP3 • CCND1 • CDKN1A • RAG1

Linperlisib plus CHOP for newly diagnosed peripheral T-cell lymphoma: A single-arm, phase Ib/II study (LINCH trial). (ASCO 2026) - P1/2, P2/3 | "Preliminary results from LINCH study suggest that linperlisib combined with CHOP as first-line treatment for PTCL achieved promising efficacy and manageable safety. A randomized controlled trial evaluating linperlisib plus CHOP versus CHOP in patients with newly diagnosed PTCL has been initiated (NCT06548347). Baseline characteristics."

P1/2 data • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukopenia • Lymphoma • Neutropenia • Peripheral T-cell Lymphoma • Pneumonia • Respiratory Diseases • T Cell Non-Hodgkin Lymphoma • PIK3CD

Multi-omics analysis of response and resistance to PI3Kδ/HDAC inhibition in cutaneous T-cell lymphoma (SID 2026) - "We previously demonstrated the efficacy of the dual PI3Kδ inhibitor linperlisib and HDAC inhibitor chidamide in CTCL. Our study provides the first spatiotemporal map of CTCL under dual PI3Kδ/HDAC inhibition. We have identified that pre-existing TLS driven by tumor-intrinsic epigenetic states is a key predictor of response, while the XCL1-cDC1 axis drives intrinsic resistance."

Cutaneous T-cell Lymphoma • Hematological Malignancies • Lymphoma • T Cell Non-Hodgkin Lymphoma • CXCL13 • CXCR5 • PIK3CD

Rapid response to linperlisib in relapsed/refractory autoimmune hemolytic anemia: a case report (PubMed, Zhonghua Xue Ye Xue Za Zhi) - No abstract available

Journal • Anemia • Autoimmune Hemolytic Anemia • Hematological Disorders • Immunology

Emerging Therapeutic Strategies in Cutaneous T-Cell Lymphoma: A Comprehensive Review of Clinical Trials. (PubMed, Am J Clin Dermatol) - "The 2020-2025 period brought meaningful therapeutic advances for CTCL, including new FDA approvals, breakthrough designations, and emergence of cellular therapy. Future development should prioritize patient-reported outcomes as co-primary endpoints, prospective biomarker validation, and combination strategies with non-overlapping toxicity profiles."

IO biomarker • Journal • Review • Cutaneous T-cell Lymphoma • Dermatology • Hematological Disorders • Hematological Malignancies • Lymphoma • Mycosis Fungoides • Non-Hodgkin’s Lymphoma • Oncology • Sezary Syndrome • Skin Cancer • T Cell Non-Hodgkin Lymphoma • CD70

Dual targeting of PI3Kδ and PPARα enhances antitumor activity via FoxO1 activation in follicular lymphoma. (PubMed, Cell Death Dis) - "Here, we show that combining the PI3Kδ inhibitor linperlisib with the pan-peroxisome proliferator-activated receptor (PPAR) agonist chiglitazar, an agent that reprograms tumor metabolism, delivers robust antitumor activity across FL models, including cell-derived and patient-derived xenografts, with a favorable tolerability profile. Compared with monotherapy, the combination consistently achieves superior tumor control in vivo without overt toxicity, supporting its clinical translation potential. Collectively, these data provide a mechanistic rationale for dual targeting of PI3Kδ and PPARα in FL and advocate for clinical evaluation of this combination with FoxO1 as a pharmacodynamic biomarker."

Journal • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology • PIK3CD • PPARA

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

Combined oral PI3Kδ inhibitor linperlisib and HDAC inhibitor chidamide in relapsed/refractory peripheral T-cell lymphoma: a multicenter phase 1 trial. (PubMed, Leuk Lymphoma) - "With a median follow-up time of 13.0 months, median duration of response (DOR), progression-free survival, and overall survival (OS) were not reached. In conclusion, linperlisib plus chidamide demonstrated a favorable safety profile and encouraging preliminary efficacy in r/r PTCL."

Journal • P1 data • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • PIK3CD

Synergistic Remission of refractory cutaneous T-cell lymphoma by linperlisib plus venetoclax via targeting the PI3K/AKT/CREB-BCL-2/MCL-1 signaling axis. (ASH 2025) - " We report a 67-year-old woman with multiply relapsed pcALCL refractory to CHOP, CHOP plus brentuximab vedotin (BV), and three courses of total skin electron beam therapy (TSEBT), who subsequently initiated combination therapy with linperlisib (PI3Kδ inhibitor) and venetoclax (BCL-2 inhibitor). In this case, dual PI3Kδ and BCL-2 blockade achieved durable remission after failure of all conventional therapies. Linperlisib suppresses BCL-2/MCL-1 expression by inhibiting the PI3K/AKT/CREB axis, synergizing with venetoclax to overcome resistance. This combination represents a novel therapeutic strategy for achieving durable remission in relapsed pcALCL."

Clinical • IO biomarker • Cutaneous T-cell Lymphoma • Dermatology • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Mycosis Fungoides • Non-Hodgkin’s Lymphoma • Sezary Syndrome • T Cell Non-Hodgkin Lymphoma • BCL2 • MCL1 • PIK3CD • TNFRSF8

Efficacy and safety of linperlisib combined with azacitidine in patients with lymphoma (ASH 2025) - "Observed adverse events included: anemia (n=12, 85.7%), pneumonia (n=10, 71.4%), thrombocytopenia (n=6, 42.9%), febrile neutropenia (n=6, 42.9%), liver function impairment (n=4, 28.6%), nausea/vomiting (n=2, 14.3%), diarrhea (n=1, 7.1%), and hypersensitivity (n=1, 7.1%). Conclusion : The combination of linperlisib and azacitidine demonstrated promising efficacy and a manageable safety profile in patients with lymphoma."

Clinical • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Immunology • Infectious Disease • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Peripheral T-cell Lymphoma • Pneumonia • Respiratory Diseases • T Cell Non-Hodgkin Lymphoma • Thrombocytopenia

The oral PI3Kdelta inhibitor Linperlisib and Obinutuzumab as response-dependent, first-line regimen for marginal zone lymphoma: A prospective single-arm Phase Ib/II Study (ASH 2025) - P1/2 | "Conclusion Front-line treatment with Linperlisib and Obinutuzumab in MZL demonstrated encouraging early efficacy with a manageable safety profile. Further enrollment and follow-up are ongoing to confirm these preliminary findings and better define the role of this response-adapted strategy in the first-line setting for MZL."

Clinical • P1/2 data • B Cell Lymphoma • Follicular Lymphoma • Indolent Lymphoma • Infectious Disease • Interstitial Lung Disease • Lymphoma • Marginal Zone Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Pneumonia • Respiratory Diseases • PIK3CD

Single center updated analysis of patients with Relapsed/Refractory peripheral T-cell lymphoma treated with linperlisib. (ASH 2025) - P2 | "In a heavily pretreated, with r/r PTCL/CTCL, linperlisib demonstrated robust activity withearly and durable responses—especially in AITL—and a manageable safety profile, including with step-down dosing. These findings support further exploration of Linperlisib in US population and use ofmaintenance dosing strategy. Overall the safety profile was manageable, and treatment-related AEs weregenerally reversible or non-life-threatening."

Clinical • Constipation • Cutaneous T-cell Lymphoma • Follicular Lymphoma • Gastroenterology • Gastrointestinal Disorder • Hematological Malignancies • Immunology • Infectious Disease • Lymphoma • Pancreatitis • Peripheral Neuropathic Pain • Peripheral T-cell Lymphoma • Respiratory Diseases • T Cell Non-Hodgkin Lymphoma • PIK3CD

Efficacy and safety results of linperlisib in adult patients with primary immune thrombocytopenia (ITP) (ASH 2025) - P1/2 | "Linperlisib was well tolerated in adult patients with relapsed/refractory ITP. Linperlisib 40mgQD demonstrated durable, and clinically significant platelet responses in all subgroups with pretreatedITP. A randomized phase 3 study will be continued to further assess the durable clinical benefits oflinperlisib in adult patients with relapsed/refractory ITP."

Clinical • Dyslipidemia • Hematological Disorders • Immune Thrombocytopenic Purpura • Immunology • Metabolic Disorders • Thrombocytopenia • Thrombocytopenic Purpura • PIK3CD

Preliminary efficacy and safety of golidocitinib in relapsed/refractory T cell and NK cell large granular lymphocyte leukemia (ASH 2025) - P2 | "Immunosuppressive therapy remains the standard first linetreatment, including methotrexate, cyclosporine A, and cyclophosphamide...Sixpatients had failed three or more prior lines including PI3Kδ inhibitor linperlisib and JAK1/2 inhibitorruxolitinib...Golidocitinib monotherapy demonstrates compelling clinical activity, including 100% response amongSTAT3 wild type evaluable patients, and a favorable safety profile in heavily pretreated r/r T-LGLLpatients. These results support its further development in this population with unmet medical needs."

Clinical • Autoimmune Hemolytic Anemia • Cutaneous T-cell Lymphoma • Gastrointestinal Disorder • Hematological Malignancies • Herpes Zoster • Immunology • Indolent Lymphoma • Leukemia • Lymphoma • Natural Killer/T-cell Lymphoma • Neutropenia • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • Thrombocytopenia • Varicella Zoster • PIK3CD • STAT3

CHOP combined with linperlisib or chidamide may decrease the risk of mortality of monomorphic epitheliotropic intestinal T-cell lymphoma: A single-center cohort study (ASH 2025) - "Based on present data, the most frequently mutated pathways in MEITL patients was JAK-STAT pathway. Surgery combined with chemotherapy may prolong their overall survival. And CHOPcombined with HDAC or PI3Kδ inhibitors may decrease risk of mortality of them."

Clinical • CNS Disorders • Hematological Malignancies • Lymphoma • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • CD20 • CD7 • ITGAE • JAK3 • NCAM1 • PIK3CD • SETD2 • STAT5B • TIA1 • TNFRSF8

PIM1 mutation drives ANXA2 membrane relocalization and promotes lymphomagenesis through PI3K/AKT/mTOR pathway in DLBCL (ASH 2025) - "In particular, thePIM1L184F mutation promoted cell proliferation and was resistant to doxorubicin in vitro and showedfaster tumor growth in vivo. Additionally, the high-throughput drug screening demonstrated thatthe PIM1L184F mutated cells were more sensitive to the PI3K inhibitor YY20394. PIM1 inhibitor SMI-4acombined with YY20394 showed synergistic antitumor effects both in vitro and in vivo.ConclusionsTaken together, these findings not only shed light on an innovative regulatory mechanismfor how PIM1L184F mutation contributes to the pathogenesis of DLBCL but also provide a potentialtherapeutic strategy for effectively managing DLBCL patients harboring PIM1L184F mutation."

IO biomarker • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • ANXA2 • PIM1 • TLR4

Linperlisib Combined With Chidamide in Patients With PTCL (clinicaltrials.gov) - P1/2 | N=134 | Recruiting | Sponsor: Yanyan Liu | N=100 ➔ 134 | Trial completion date: May 2026 ➔ Dec 2027 | Trial primary completion date: Dec 2025 ➔ May 2027

Enrollment change • Trial completion date • Trial primary completion date • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma