Istodax (romidepsin) / Astellas, BMS - LARVOL DELTA

Engineered romidepsin biosynthetic pathways in Escherichia coli Nissle 1917 improve the efficacy of bacteria-mediated cancer therapy. (PubMed, PLoS Biol) - "Also, targeted synthesis reduced FK228's cardiotoxicity and mortality. Engineered EcN enables drug biosynthesis and precise delivery, offering powerful anticancer activity."

Journal • Cardiovascular • Oncology

Therapeutic potential of PCNA and HDAC inhibitor combinations in cutaneous T-cell lymphoma and other cancers (AACR 2026) - "Guided by post-translational modification signature enrichment analysis of phosphorylated proteins after AOH1996 treatment, we tested its combination with histone deacetylase inhibitors (HDACi) belinostat and vorinostat...Furthermore, AOH1996 combined with vorinostat or romidepsin, both FDA-approved for treatment of CTCL, showed synergistic growth inhibition in four cell lines derived from CTCL. Mechanistic studies revealed enhanced DNA damage response, cell cycle arrest, and apoptosis in CTCL cells treated with AOH1996 and HDACi. These findings support the therapeutic potential of combining AOH1996 with HDACi for the treatment of cancers, including CTCL."

Cutaneous T-cell Lymphoma • Hematological Malignancies • Lymphoma • Neuroblastoma • Oncology • Solid Tumor • T Cell Non-Hodgkin Lymphoma • HDAC3 • PCNA

A comprehensive approach to targeting PI3K and Hippo pathways in sarcomas (AACR 2026) - "Cells were treated with MK2206 (Akt inhibitor), Everolimus (mTORC1 inhibitor), Romidepsin (HDAC inhibitor) and VT-107 (TEAD inhibitor) alone or in combination. TEAD inhibition disrupts TAZ/YAP transcriptional activity downstream, while HDAC inhibition restores Hippo signaling and suppresses TAZ/YAP transcription, and PI3K pathway inhibitors reduce survival signaling. These findings provide rationale for further investigation into dual-pathway inhibition as a therapeutic strategy, including mechanistic studies and in vivo validation to define therapeutic windows and potential clinical applications."

Oncology • Rhabdoid Tumor • Rhabdomyosarcoma • Sarcoma • Solid Tumor • LATS1 • MST1 • PTEN • TAFAZZIN

CyTOF analysis of targeted therapy in addition to standard of care against Ewing sarcoma tumor subpopulations (AACR 2026) - "SOC involves chemotherapy using alternating cycles of Vincristine, Doxorubicin, Cyclophosphamide (VDC) with Ifosfamide and Etoposide (IE). We have identified that the combination of romidepsin with IE, but not IE alone, leads to an increase in DNA damage in the EWS:FLI1low and cancer stem cell populations. This suggests that the addition of romidepsin to SOC may improve treatment efficacy against subpopulations of tumor cells that are known to be chemoresistant. Further, this study highlights the use of CyTOF to assess treatment effects within ES tumor subpopulations to identify therapies that may be more effective against chemoresistant populations."

Clinical • Ewing Sarcoma • Oncology • Sarcoma • Solid Tumor • EWSR1 • FLI1

A comprehensive endometrial cancer organoid biobank reveals subtype-specific transcriptional programs and therapeutic targets (AACR 2026) - "High-throughput drug screening identified class I HDAC inhibitor (romidepsin, RD) as a consistent activity signal... This large, racially diverse EC PDO biobank provides a robust preclinical platform that captures EC heterogeneity and enables controlled, subtype-resolved analyses. Integrated multi-omics and functional perturbation identify a spindle-dependency axis in CS, supporting subtype-specific and ancestry-aware therapy development."

Carcinosarcoma • Endometrial Cancer • Oncology • Sarcoma • Solid Tumor • CDK1 • KIF11 • MSI • PIK3CA • PTEN

Epigenetic modulators romidepsin and mithramycin A reactivate tumor-suppressive programs and suppress c-MYC under hyperthermic conditions in colorectal peritoneal metastasis (AACR 2026) - "To evaluate whether epigenetically active agents improve antitumor responses relevant to HIPEC, we compared the histone deacetylase inhibitor romidepsin (Ro) and the Sp1 transcription factor inhibitor mithramycin A (MA) with the standard HIPEC agent mitomycin C (MMC) in HCT116 and HT29 colorectal cancer cells exposed to normothermic (37°C) or hyperthermic (42°C) conditions for 90 minutes. Hyperthermia variably augmented drug responses in a pathway-dependent manner, suggesting synergistic interactions between heat stress and chromatin remodeling. Ongoing studies using a murine HIPEC model with HCT116 peritoneal xenografts will define the molecular correlates and therapeutic potential of integrating epigenetic modulators into HIPEC-based regimens for colorectal peritoneal metastasis."

Colorectal Cancer • Oncology • Solid Tumor • CASP3 • CDKN1A • DKK1 • HIC1 • MYC • SPRY2 • TIMP3

METTL7A and METTL7B confer resistance to the oral thiol-based histone deacetylase inhibitor ST7612AA1 (AACR 2026) - "The FDA-approved HDAC inhibitor, romidepsin, and some pre-clinical HDAC inhibitors, including ST7612AA1, KD-5170, and NCH-51, are prodrugs that are converted to their active forms containing thiol as ZBGs...Parental HepG2 cells were selected with ST7612AA1 and valspodar continuously for 3 months to generate ST7612AA1-resistant HepG2 cell lines...While HDAC inhibitors have been effective against T-cell lymphomas, they have not shown success in treating solid tumors. This work establishes METTL7A and METTL7B overexpression as a novel mechanism of resistance to thiol-containing HDAC inhibitors and a potential target for the treatment of solid cancer types."

Epigenetic controller • Breast Cancer • Hematological Malignancies • Liver Cancer • Lymphoma • Oncology • Solid Tumor • T Cell Non-Hodgkin Lymphoma

High-throughput drug screening and single-cell network analysis identify rational combination therapies in IDH-mutant glioma (AACR 2026) - "For example, we found that AC-like cells may first be primed with the mTOR inhibitor temsirolimus to reprogram them toward a more drug-sensitive OC-like state, thereby converting a resistant lineage into one that is more vulnerable, including to the new class of IDH1 inhibitors. A second-line agent such as the HDAC inhibitor romidepsin or the topoisomerase inhibitor irinotecan can then be used, possibly in combination with IDH1 inhibitors, to target the resulting OC-like and pre-existing OC/NPC cells, thus implementing a two-step, sequential treatment strategy...Single-cell and spatial transcriptomic profiling (10x Genomics Xenium) of treated slices will map the reprogramming and elimination of malignant subpopulations in situ. Together, this framework provides a blueprint for discovering state-specific dependencies in IDH-mutant glioma and for guiding rational, combination-based strategies to overcome intratumoral heterogeneity."

Combination therapy • Brain Cancer • Glioma • Oncology • Solid Tumor • IDH1

Study Investigating Intravesical HDAC Inhibition to Improve Response to Immuno-Oncology Agents (clinicaltrials.gov) - P1 | N=12 | Suspended | Sponsor: H. Lee Moffitt Cancer Center and Research Institute | Recruiting ➔ Suspended

Trial suspension • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Current Practice and Research in T-cell and NK/T-cell Lymphoma in Japan (ICKSH 2026) - "For patients with major subtypes of peripheral T -cell lymphoma (PTCL), including PTCL not otherwise specified, angioimmunoblastic T -cell lymphoma (AITL), and anaplastic large cell lymphoma, the 2024 Japanese Society of Hematology (JSH) guidelines recommend the use of brentuximab vedotin (BV) -CHP for CD30 -positive tumors and CHOP -like regimens for CD30 -negative tumors as the first -line treatment...For patients with relapsed /refractory T-cell and NK/T -cell lymphoma, many therapeutic drugs (mogamulizumab, BV , pralatrexate, forodesine, romidepsin, alectinib, denileukin diftitox, tucidinostat, darinaparsin, and valemetostat) are approved and available in Japan...However, among immune checkpoint inhibitors, only atezolizumab was approved for the treatment of ENKL in 2025, and little experience is available with its use. Patients with ENKL in Japan account for less than 1% of all lymphoma patients, which is as low as in Western countries. To fill these gaps, an..."

Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Natural Killer/T-cell Lymphoma • Non-Hodgkin’s Lymphoma • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • TNFRSF8

Comprehensive molecular profiling of penile carcinoma reveals histone deacetylation, cell cycle regulators and heat shock proteins as targetable therapeutic strategies (DKK 2026) - "Current treatment options include surgery, radiotherapy, and the TIP regimen (paclitaxel, ifosfamide, cisplatin), despite the latter achieving moderate response rates of 15 - 55 %...Functional assays assessed the efficacy of standard chemotherapeutic drugs as compared to inhibitors targeting HDAC (romidepsin, quisinostat), CDK4/6 (palbociclib, ribociclib), and HSP90 (17-AAG, PU-H71)... Compared to standard therapeutic agents such as cisplatin, 5-FU, ifosfamide, and irinotecan, treatment with romidepsin, quisinostat, palbociclib, 17-AAG, and PU-H71 notably reduced viability, induced apoptosis, and caused an accumulation in the G2 / M cell cycle phase in most PeCa cell lines. Our findings highlight HDAC, CDK4/6, and HSP90 inhibitors as promising therapeutic options for PeCa while providing a resource for novel putative biomarker and future targeted therapies."

Genito-urinary Cancer • Oncology • Penile Cancer • Solid Tumor • ANXA5 • CDC37 • HIF1A

Integrating patient -derived organoids to uncover synergistic efficacy of romidepsin and everolimus in pancreatic neuroendocrine tumors (ENETS 2026) - "This study establishes PDOs as clinically relevant preclinical models for GEP-NETs and supports the therapeutic potential of combined mTOR and HDAC inhibition. The integra - tion of PDO testing and high-throughput drug screening provides a robust platform for identifying and validating novel treatment strategies in NENs."

Clinical • Endocrine Cancer • Gastrointestinal Neuroendocrine Tumor • Neuroendocrine Carcinoma • Neuroendocrine Tumor • Oncology • Solid Tumor

PTCL13: Ro Plus CHOEP as First Line Treatment Before HSCT in Young Patients With Nodal Peripheral T-cell Lymphomas (clinicaltrials.gov) - P1/2 | N=110 | Recruiting | Sponsor: Fondazione Italiana Linfomi ONLUS | Active, not recruiting ➔ Recruiting

Enrollment open • Bone Marrow Transplantation • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • Transplantation

PTCL13: Ro Plus CHOEP as First Line Treatment Before HSCT in Young Patients With Nodal Peripheral T-cell Lymphomas (clinicaltrials.gov) - P1/2 | N=92 | Active, not recruiting | Sponsor: Fondazione Italiana Linfomi ONLUS | Trial completion date: Mar 2027 ➔ Oct 2026

Trial completion date • Bone Marrow Transplantation • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • Transplantation

PTCL13: Ro Plus CHOEP as First Line Treatment Before HSCT in Young Patients With Nodal Peripheral T-cell Lymphomas (clinicaltrials.gov) - P1/2 | N=92 | Active, not recruiting | Sponsor: Fondazione Italiana Linfomi ONLUS | Recruiting ➔ Active, not recruiting | Trial primary completion date: Sep 2021 ➔ Oct 2020

Enrollment closed • Trial primary completion date • Bone Marrow Transplantation • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • Transplantation

PTCL13: Ro Plus CHOEP as First Line Treatment Before HSCT in Young Patients With Nodal Peripheral T-cell Lymphomas (clinicaltrials.gov) - P1/2 | N=89 | Active, not recruiting | Sponsor: Fondazione Italiana Linfomi - ETS | Trial completion date: Oct 2026 ➔ Feb 2026

Trial completion date • Bone Marrow Transplantation • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • Transplantation

A phase 1 trial of romidepsin, azacitidine, dexamethasone and lenalidomide in relapsed or refractory T-cell lymphoma. (PubMed, Blood Adv) - P1 | "This novel combination effectively bridged some patients with refractory TCL to consolidation such as allogeneic transplantation. (NCT04447027)."

Journal • P1 data • Hematological Disorders • Hematological Malignancies • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma • Thrombocytopenia • Transplantation

PTCL13: Ro Plus CHOEP as First Line Treatment Before HSCT in Young Patients With Nodal Peripheral T-cell Lymphomas (clinicaltrials.gov) - P1/2 | N=110 | Active, not recruiting | Sponsor: Fondazione Italiana Linfomi ONLUS

New P1/2 trial • Bone Marrow Transplantation • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • Transplantation

PTCL13: Ro Plus CHOEP as First Line Treatment Before HSCT in Young Patients With Nodal Peripheral T-cell Lymphomas (clinicaltrials.gov) - P1/2 | N=110 | Recruiting | Sponsor: Fondazione Italiana Linfomi ONLUS | Trial completion date: Mar 2025 ➔ Mar 2027 | Trial primary completion date: Sep 2019 ➔ Sep 2021

Trial completion date • Trial primary completion date • Bone Marrow Transplantation • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • Transplantation

PTCL13: Ro Plus CHOEP as First Line Treatment Before HSCT in Young Patients With Nodal Peripheral T-cell Lymphomas (clinicaltrials.gov) - P1/2 | N=110 | Recruiting | Sponsor: Fondazione Italiana Linfomi ONLUS | Trial primary completion date: Sep 2017 ➔ Sep 2019

Trial primary completion date • Bone Marrow Transplantation • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • Transplantation

Evaluation of antitumor response to HDAC inhibitors in advanced head and neck cancer: A proportional meta-analysis of clinical trials. (PubMed, J Oncol Pharm Pract) - "Out of these 7 studies, the average proportion of antitumor response was calculated to be 0.758 among HNC patients who received HDACi concurrently with chemotherapy, chemoradiotherapy, and targeted therapy, whereas the average proportion of antitumor response rate to HDACi was 0.485 among priorly treated HNC patients. Vorinostat was the most used HDACi, where the proportion of favorable response was 0.49 compared to the non-vorinostat HDACi (0.77), like valproic acid, panobinostat, and romidepsin.ConclusionThe overall antitumor response to HDACi was found to be 0.65 (65%), which supports the use of HDACi among advanced HNC patients, particularly along with the concurrent chemo/chemoradiotherapy or targeted therapy."

Journal • Retrospective data • Review • Head and Neck Cancer • Oncology • Solid Tumor

Efficacy and Safety of E7777 (improved purity Denileukin diftitox [ONTAK]) in Patients with Relapsed or Refractory Cutaneous T-Cell Lymphoma: Results from Pivotal Study 302 (ASH 2022) - P3 | "Approximately half (34 of 69; 49.3%) of patients had prior exposure to 1 or more FDA-approved targeted therapeutics: romidepsin, brentuximab, or mogamulizumab. In study 302, E7777 at a dose of 9 mcg/kg/day demonstrated clinical efficacy and clinically meaningful benefit in heavily pre-treated patients with relapsed/refractory CTCL. The ORR of 36.2% per IRC (42.3% by investigator assessment) showed that a substantial proportion of these heavily pretreated patients experienced clinical benefit after E7777 treatment similar to ONTAK. The observed tumor responses were rapid, durable, and deep."

Clinical • Cutaneous T-cell Lymphoma • Dermatology • Fatigue • Hematological Malignancies • Hepatology • Infectious Disease • Lymphoma • Oncology • Pruritus • T Cell Non-Hodgkin Lymphoma • IL2

Rationalising the inclusion of HDAC inhibitors with standard-of-care chemotherapy for high-risk neuroblastoma (LCC 2026) - "Within treatment naïve neuroblastomas, priming with the histone deacetylase (HDAC) inhibitor Vorinostat could overcome this chemoresistance and sensitise tumours to treatment with specific standard-of-care chemotherapies...A key observation from this study was that the HDAC inhibitors Romidepsin and Panobinostat led to increased apoptosis...These mechanistic insights are now being leveraged to design rationalised treatment regimens that combine these HDAC inhibitors with standard-of-care chemotherapies. This includes the addition of a priming step with Belinostat, which we have now demonstrated is capable of significantly reducing tumour growth and doubling median survival times in patient-derived xenograft models treated with topotecan and cyclophosphamide."

Neuroblastoma • Solid Tumor

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 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