Epidaza (chidamide) / Chipscreen, Meiji Seika, Eisai, HUYA Bioscience, GNT Biotech - LARVOL DELTA

Clinical activity of chidamide-containing regimens after prior PD-1-based therapy in two patients with microsatellite-stable metastatic colorectal cancer: a case series and narrative review. (PubMed, Front Oncol) - "Case 1: A 60-year-old woman with BRAF V600E-mutant, right-sided, MSS mCRC received third-line surufatinib plus camrelizumab, with a best response of stable disease (SD) and a progression-free survival (PFS) of 5 months...Case 2: A 43-year-old man with recurrent RAS/BRAF wild-type MSS mCRC received fifth-line surufatinib plus sintilimab (PR, PFS 8.5 months) and, after progression, seventh-line chidamide plus sintilimab plus bevacizumab (SD, PFS 5.5 months)...As descriptive observations, these findings are hypothesis-generating only and are insufficient to demonstrate reversal of immunotherapy resistance or survival benefit. Prospective biomarker-driven studies are warranted to evaluate epigenetic-immunotherapy combinations in this subgroup."

IO biomarker • Journal • Colorectal Cancer • Gene Therapies • Oncology • Solid Tumor • BRAF

A phase II clinical trial of sintilimab plus chidamide combined with or without bevacizumab in patients with MSS/pMMR metastatic colorectal cancer (ESMO 2023) - P2 | "Grade 3 and above TEAEs occurred in 7 (30.4%) patients in the doublet arm and 13 (42.0%) patients in the triplet arm. Conclusions Sintilimab combined with chidamide and bevacizumab had promising efficacy and tolerable toxicity in MSS mCRC patients."

Clinical • Metastases • P2 data • Colorectal Cancer • Gastrointestinal Cancer • Microsatellite Instability • Oncology • Solid Tumor • MSI

Chidamide combined with Vinorelbine and Capecitabine for HER2-Negative Advanced Breast Cancer: A Single-Arm, Single-Center, Phase II Clinical Trial (ESMO 2026) - No abstract available

Clinical • Metastases • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • HER-2

Radiotherapy-Induced In Situ Vaccination Combined with Chidamide and PD-1 Antibody for Advanced Soft Tissue Sarcoma: An Exploratory, Single-Center, Single-Arm Trial (ESMO 2026) - No abstract available

Clinical • Metastases • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Chidamide Combined with Anlotinib in Patients with Advanced Soft Tissue Sarcoma After Failure of Standard Therapy: A Single-Center, Single-Arm Phase II Trial (ESMO 2026) - No abstract available

Clinical • Metastases • P2 data • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Efficacy and Safety of QL1706 Combined with Chidamide, Nab-Paclitaxel, and Gemcitabine as First-Line Treatment for Metastatic Pancreatic Cancer: A Prospective, Single-Arm Clinical Trial (ESMO 2026) - No abstract available

Clinical • Metastases • Oncology • Pancreatic Cancer • Solid Tumor

Chidamide-Mediated Epigenetic Reprogramming Improves the Anti-Lymphoma Efficacy of Allogeneic CAR-γδT Cells (ESMO 2026) - No abstract available

Clinical • Hematological Malignancies • Lymphoma • Oncology

Primary Analysis of HBI-8000-303: A Randomized Phase 3 Trial of Nivolumab plus HBI-8000 or Placebo in Advanced Melanoma (ESMO 2026) - No abstract available

Clinical • Late-breaking abstract • Metastases • P3 data • Melanoma • Oncology • Skin Cancer • Solid Tumor

Oral Manifestations and Management of Lymphoma-Associated Hemophagocytic Lymphohistiocytosis. (PubMed, J Stomatol Oral Maxillofac Surg) - "The oral lesions were managed with Kangfuxin mouthwashes, while the underlying lymphoma and HLH were treated with dexamethasone and etoposide, combined with chidamide and tislelizumab. These oral lesions, as a manifestation of localized lymphoma progression, may serve as early clinical clues to lymphoma relapse with secondary HLH, rather than being a specific early sign of LA-HLH itself. Increased awareness of these potential oral findings among clinicians and dentists could facilitate earlier diagnosis of lymphoma relapse in LA-HLH patients and improve the multidisciplinary management of associated complications."

Journal • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Hemophagocytic lymphohistiocytosis • Immunology • Lymphoma • Natural Killer/T-cell Lymphoma • Oncology • Rare Diseases • T Cell Non-Hodgkin Lymphoma • Transplantation

Epigenetic agents plus anti-PD-1 reshapes tumor microenvironment and restores antitumor efficacy in Hodgkin lymphoma. (PubMed, Blood) - P2 | "In this study, we evaluated the efficacy and safety of a triplet regimen consisting of the histone deacetylase inhibitor chidamide, decitabine and anti-PD-1 camrelizumab (CDP) in 52 patients with relapsed/refractory cHL who had previously received DP therapy (NCT04233294)...The classical CD30+ HRS-like cells interacted with the abundant immunosuppressive IL21+CD4+ T helper cells, forming a positive feedback loop that supported their survival...CDP treatment promoted the activation of diverse tumor-reactive CD8+ T cells and suppressed the proliferation of IL21+CD4+ T cells by inhibiting STAT1/3 signaling, thereby alleviating their immunosuppressive effects. These findings provide insights into the cHL microenvironment that contributes to anti-PD-1 resistance and highlight the therapeutic effectiveness of dual epi-immunotherapy in overcoming immunotherapy resistance."

Biomarker • Journal • Tumor microenvironment • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology • CD4 • CD8 • IL21 • STAT1 • TNFRSF8

Chidamide-maintained long-term clinical remission with persistent T-Cell clone in refractory T-LGL leukemia-associated pure red cell aplasia: A six-year follow-up. (PubMed, Leuk Res Rep) - "We report a case of refractory T-LGL leukemia complicated by PRCA that was resistant to cyclosporine (CsA). Then the patient achieved rapid disease control with chidamide plus thalidomide in the early phase, and has maintained long-term remission for six years on chidamide monotherapy after thalidomide discontinuation. Notably, clonal T-cell receptor (TCR) variable β-chain (Vβ) 3 persisted on flow cytometry throughout the treatment course. As an epigenetic modulator, chidamide represents a more convenient and promising therapeutic strategy for managing T-LGL leukemia, prompting us to present this case."

Journal • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology • T-Cell Large Granular Lymphocyte Leukemia

Durable immunovirological control after sequential mogamulizumab and tucidinostat in relapsed or refractory adult T-cell leukemia/lymphoma. (PubMed, Front Immunol) - "In both patients, TCR Vβ repertoire analysis showed memory CD8+ T-cell-predominant patterns, including expansion of a Vβ2 memory CD8+ T-cell population. These observations are hypothesis-generating and suggest that sequential tumor debulking, CCR4/Treg-axis modulation, and epigenetic treatment may create a context permissive for HTLV-1 antigen-specific cellular immune surveillance in selected patients with ATLL."

Journal • Adult T-Cell Leukemia-Lymphoma • Bone Marrow Transplantation • Gene Therapies • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Transplantation • CCR4 • CD4 • CD8 • IL2

Venetoclax-Azacitidine in Combination With Chidamide and CAG in Fit Older Patients With Acute Myeloid Leukaemia (clinicaltrials.gov) - P3 | N=120 | Recruiting | Sponsor: Chinese PLA General Hospital | Phase classification: P2 ➔ P3

Phase classification • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

TARGETED AGENTS COMBINED WITH CHOP COMPARED WITH CHOP AS THE FIRST-LINE THERAPY FOR PERIPHERAL T-CELL LYMPHOMA: PRELIMINARY RESULTS FROM A PHASE 2 GUIDANCE-03 TRIAL (ICML 2023) - P2 | "Standard CHOP (Cyclophosphamide, doxorubicin, vincristine, and prednisolone) chemotherapy is still the most widely used regimen for front-line management...X (i.e., targeted agent) was added from the second to sixth cycles as following, intravenous decitabine 10 mg/m2 on day -5 to -1 if with TP53 mutation. Subcutaneous azacytidine 100 mg on day −7 to −1 if with TET2/KMT2D mutation. Oral chidamide 20 mg on day1, 4, 8, 11 if with CREBBP/EP300 mutation. Oral lenalidomide 25 mg on day 1–10 if without above mutations... Preliminary analysis showed targeted agents combined with CHOP was effective and safe compared with standard CHOP in PTCL. Therapeutic strategy specifically towards molecular features may change current PTCL management in front-line setting."

Clinical • P2 data • Hematological Malignancies • Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • CREBBP • EP300 • KMT2D • TET2 • TP53

A phase II trial of the combination of chidamide and toripalimab in patients with advanced sarcoma (ESMO 2025) - P2 | "The mPFS for well/dedifferentiated liposarcoma patients was significantly prolonged compared to other patients (17.1 months vs. 3.6 months, P <0.001). Conclusions Chidamide with Toripalimab every 21 days was well tolerated and showed promising efficacy in patients with advanced sarcoma, especially for well/dedifferentiated liposarcoma."

Clinical • Metastases • P2 data • Hematological Malignancies • Leiomyosarcoma • Liposarcoma • Oncology • Osteosarcoma • Sarcoma • Solid Tumor

Chidamide plus venetoclax as effective and safe maintenance therapy in high-risk acute myeloid leukemia and myelodysplastic syndrome post-transplantation. (PubMed, Ann Hematol) - "No treatment-related mortality, tumor lysis syndrome, or severe acute graft-versus-host disease (GVHD) occurred. In conclusion, CHI plus VEN as post-transplant maintenance therapy shows encouraging efficacy and a manageable safety profile in high-risk AML/MDS patients, representing a promising strategy for relapse prevention."

Journal • Acute Graft versus Host Disease • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Leukemia • Myelodysplastic Syndrome • Neutropenia • Oncology • Thrombocytopenia • Transplantation

Histone deacetylase inhibitors as venetoclax-sensitising partners in acute myeloid leukaemia: Mechanisms, pharmacology and translational perspectives. (PubMed, Br J Pharmacol) - "Early HDAC inhibitor-containing composite regimens, particularly chidamide-based CACAG-VEN (chidamide, venetoclax, azacitidine, low-dose cytarabine, aclarubicin and granulocyte colony-stimulating factor), report high response rates, including overall response rate of 76.5-98.0%, complete remission/complete remission with incomplete count recovery or composite complete remission of 73.5-93.3%, and measurable residual disease negativity of 44-61%. Future development should prioritise biomarker-selected trials that hold non-HDAC components constant, incorporate pharmacodynamic HDAC engagement and BH3 profiling, and account for cytochrome P450 3A-mediated drug interactions. HDAC inhibitor-venetoclax combinations are mechanistically rational, but standard-of-care positioning requires randomised or pharmacodynamic validation."

IO biomarker • Journal • Review • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • BCL2 • HDAC1

Venetoclax, Chidamide, and Chiglitazar Sodium (VCC) in Patients With Relapsed/Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: The First Affiliated Hospital of Xiamen University

New P2 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

A PIVOTAL STUDY OF SHR2554, AN ORAL INHIBITOR AGAINST ENHANCER OF ZESTE HOMOLOG 2 (EZH2), IN RELAPSED OR REFRACTORY (R/R) PERIPHERAL T-CELL LYMPHOMA (PTCL) (EHA 2025) - P1, P3 | "All patients had received chemotherapy regimens; moreover, all patients had been treated with tucidinostat or brentuximab vedotin (tucidinostat, 59 [88.1%]; brentuximab vedotin, 21 [31.3%]; both, 13 [19.4%]). The pivotal study met its primary endpoint, demonstrating that SHR2554 is efficacious and has a manageable safety profile in patients with r/r PTCL. Our findings position SHR2554 as a new potential therapeutic option for this challenging-to-treat population. A randomized controlled phase 3 study comparing SHR2554 with standard therapy for r/r PTCL is currently underway (ClinicalTrials.gov, NCT06122389)."

Anemia • Hematological Disorders • Lymphoma • Natural Killer/T-cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • ALK • EZH2

Rare acute myeloid leukemia harboring BCR/ABL1 (P210), AML1-MDS1/EVI1, and AML1/EAP: case report and literature review. (PubMed, Front Oncol) - "The patient received induction chemotherapy with IA+VEN (idarubicin, cytarabine and venetoclax) regimen and achieved complete remission (CR); however, disease progression occurred during the first consolidation therapy...Post-transplant maintenance therapy consisting of chidamide, decitabine, and dasatinib was administered regularly. At the latest follow-up 3 months after transplantation, the patient remained in continuous molecular remission, with negative minimal residual disease (MRD) and significantly reduced BCR::ABL1 and EVI1 transcript levels. This case indicates that individualized sequential therapy including targeted agents, combination chemotherapy, allo-HSCT with chidamide-containing conditioning, and post-transplant epigenetic maintenance may provide effective disease control and favorable long-term outcomes for ultra-high-risk AML with multiple adverse molecular abnormalities."

Journal • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology • Transplantation • ABL1 • BCOR • BCR • MECOM

RCLARITY: A Prospective Phase II Study of Rituximab Combined With Lenalidomide and Chidamide (RLC) for the Treatment of Relapsed/Refractory Angioimmunoblastic T-Cell Lymphoma. (PubMed, Am J Hematol) - P2 | "Overall, the RLC regimen induced clinically meaningful anti-tumor activity with manageable toxicity in patients with r/r AITL. Trial Registration: ClinicalTrials.gov identifier: NCT04319601."

Journal • P2 data • Cardiovascular • Hematological Disorders • Hematological Malignancies • Leukopenia • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma • Thrombocytopenia

Radiotherapy-induced in situ vaccination combined with Chidamide and PD-1 antibody for advanced soft tissue sarcoma: An exploratory, single-center, single-arm trial (KSMO 2026) - No abstract available

Clinical • Metastases • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Chidamide in HR-AML (clinicaltrials.gov) - P=N/A | N=33 | Active, not recruiting | Sponsor: Guangdong Second Provincial General Hospital

New trial • Real-world evidence • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • KMT2A • NUP98

Oral HDAC inhibitor tucidinostat in patients with relapsed or refractory peripheral T-cell lymphoma: phase IIb results. (PubMed, Haematologica) - P2b | "In conclusion, the favorable efficacy and safety profiles indicate that tucidinostat would be a new therapeutic option in patients with R/R PTCL. (ClinicalTrials.gov identifier: NCT02953652)."

Journal • P2b data • Hematological Disorders • Hematological Malignancies • Leukopenia • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • Thrombocytopenia

Chidamide‑augmented BEAM conditioning and maintenance in first-remission T‑cell lymphoma: a single‑arm phase 2 experience. (PubMed, Bone Marrow Transplant) - No abstract available

Journal • P2 data • Hematological Malignancies • Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma