Efficacy and Safety of Epirubicin Plus Anlotinib Versus Epirubicin Plus Ifosfamide as Standard First-Line Regimens in Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma: A Randomized, Non-Comparative Study

Start Date01 Dec 2025

Sponsor / Collaborator-

NCT06835049

/ RecruitingPhase 2

Feasibility of Total Neoadjuvant Treatment With HYPErthermia in Patients With High-risk Extremity and Trunk Soft Tissue Sarcoma (TNT-HYPE). A Multicenter, Single Arm, Open Label, Phase II Trial

Soft tissue sarcomas (STSs) are rare cancers with a 5-year survival rate of 60%, and there is no standard treatment for high-risk extremity and trunk STSs (eSTS). A phase III trial suggests that adding moderate regional hyperthermia (HT) to anthracycline-based chemotherapy, followed by surgery and radiotherapy (RT), can improve 10-year overall survival by 10%. This trial aims to optimize treatment by combining the most effective regimens from chemotherapy, HT, RT, and surgery, and will evaluate the feasibility of this new total neoadjuvant treatment (TNT) approach.

Start Date15 Nov 2025

Sponsor / Collaborator-

NCT06820957

/ Active, not recruitingPhase 2/3IIT

Randomized Phase 2/3 Trial of Vincristine-Irinotecan-Regorafenib in Combination With Vincristine-Doxorubicin-Cyclophosphamide (VDC) and Ifosfamide-Etoposide (IE) in Patients With Newly Diagnosed Metastatic Ewing Sarcoma

This phase II/III trial compares the effect of vincristine, irinotecan, and regorafenib (VIrR) in combination with vincristine, doxorubicin, cyclophosphamide (VDC), ifosfamide and etoposide (IE) to usual treatment with VDC/IE for the treatment of newly diagnosed Ewing sarcoma or other round cell sarcomas that have spread from where they first started (primary site) to other places in the body (metastatic). Vincristine is in a class of medications called vinca alkaloids. It works by stopping tumor cells from growing and dividing and may kill them. Irinotecan is in a class of antineoplastic medications called topoisomerase I inhibitors. It blocks a certain enzyme needed for cell division and deoxyribonucleic acid (DNA) repair and may kill tumor cells. Regorafenib, a type of kinase inhibitor and a type of antiangiogenesis agent, blocks certain proteins, which may help keep tumor cells from growing. It may also prevent the growth of new blood vessels that tumors need to grow. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's DNA and may kill tumor cells. It also blocks a certain enzyme needed for cell division and DNA repair. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill tumor cells. It may also lower the body's immune response. Ifosfamide, a type of alkylating agent and a type of antimetabolite, attaches to DNA in cells and may kill tumor cells. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill tumor cells. Giving VIrR/VDC/IE may be more effective than usual treatment with VDC/IE in treating patients with newly diagnosed metastatic Ewing sarcoma or other round cell sarcomas.

Start Date10 Nov 2025

Sponsor / Collaborator

The Children's Oncology Group Foundation, Inc.

100 Clinical Results associated with Ifosamide

100 Translational Medicine associated with Ifosamide

100 Patents (Medical) associated with Ifosamide

8,953

Literatures (Medical) associated with Ifosamide

01 Mar 2026·Journal of Stomatology Oral and Maxillofacial Surgery

Carbon ion radiotherapy and AI chemotherapy for soft tissue sarcoma of the temporomandibular joint: A case report of 5-year disease-free survival without wide resection

Article

Author: Katase, Naoki ; Miura, Kei-Ichiro ; Sumi, Misa ; Yamada, Tomohiro ; Nomura, Kentaro ; Hara, Masahito

We report a case of soft tissue sarcoma (STS) arising in the temporomandibular joint (TMJ), a rare site associated with considerable functional and aesthetic challenges when resection is required. A 33-year-old female with neurofibromatosis type 1 presented with progressive swelling in the right TMJ. Imaging revealed an enlarging, irregular region. Histopathological findings were suggestive of a high-grade STS, but definitive subclassification was not possible. The patient declined surgery due to potential facial nerve injury and cosmetic concerns. As an alternative, a combination of carbon ion radiotherapy and AI chemotherapy (ifosfamide and doxorubicin) was administered. At 5 years and 7 months post-treatment, the patient remains recurrence-free with preserved function and appearance. This case highlights the therapeutic potential of multidisciplinary, non-surgical strategies for head and neck STS when histologic ambiguity exists and radical surgery poses significant risk.

01 Dec 2025·PEDIATRIC BLOOD & CANCER

Ifosfamide Neurotoxicity Revisited: Recurrence Triggered by Cyclophosphamide—A Rare Clinical Insight

Letter

Author: Mishra, Priyadarashani ; L, Appaji ; Kumar, Arun ; Rao, Nishkala Uday ; Kaushik, Prakruthi S.

01 Dec 2025·CANCER CHEMOTHERAPY AND PHARMACOLOGY

Substitution of ifosfamide for cyclophosphamide in the TI-CE regimen: pharmacology and dose justification in a patient with refractory metastatic germ-cell tumor post-nephrectomy—A case report

Article

Author: Smits, Minke ; Sijm, Joost ; van Erp, Nielka P ; Huitema, Alwin D R ; de Jong, Loek A W ; Desar, Ingrid ; Hulskotte, Lotte M G

Abstract:

Background:

High-dose chemotherapy (HDCT) combined with autologous stem cell transplantation (ASCT) rescue is an effective treatment option for relapsed or refractory germ-cell tumors. The TI-CE regimen, consisting of paclitaxel and ifosfamide for stem cell mobilization followed by high dose carboplatin and etoposide with ASCT rescue, is frequently used in the treatment of refractory disease. This regimen is challenging in patients who have undergone unilateral nephrectomy, since potential nephrotoxicity of ifosfamide poses a serious risk for permanent damage of the preserved kidney. Currently, the literature lacks data on the substitution of ifosfamide in the TI-CE regimen for an alternative chemotherapeutic agent with equivalent potency while being less nephrotoxic.

Case presentation:

We present a case of a patient with refractory progressive metastatic germ-cell tumor who underwent nephrectomy and was successfully treated with a modified chemo-mobilization strategy. In the TI-CE protocol, ifosfamide was replaced for cyclophosphamide (TC-CE), resulting in a sufficient stem cell harvest through a single apheresis session. Post chemo-mobilization, LDH and hCG + hCGβ levels were normalized. Renal function remained stable throughout the course of treatment. Two months after HDCT, the patient showed a complete metabolic response, with no detectable tumor remnants. Currently, one year post-therapy, there are no signs of disease recurrence.

Conclusion:

An effective and potentially less nephrotoxic chemo-mobilization regimen, using paclitaxel and cyclophosphamide (TC-CE), was administered to a patient with refractory metastatic germ-cell tumor who underwent HDCT followed by ASCT rescue after unilateral nephrectomy. Cyclophosphamide demonstrated to be a viable substitute for ifosfamide within the TI-CE regimen.

News (Medical) associated with Ifosamide

24 Jun 2025

·pipelinereview.com

Thermosome Reports Encouraging Clinical Data of THE001 in Advanced Soft Tissue Sarcomas

MUNICH, Germany I June 24, 2025 I Thermosome GmbH , a clinical-stage drug development company focused on targeted tumor therapies, today announced new, encouraging data from its ongoing Phase I clinical trial evaluating its lead compound THE001 (DPPG 2 -TSL-DOX) in combination with regional hyperthermia (RHT) for the treatment of soft tissue sarcomas (STS). The Phase I study is assessing the safety, pharmacokinetics (PK), and preliminary efficacy of THE001 + RHT in participants with locally advanced unresectable or metastatic STS, who have exhausted all prior treatment options, including standard doxorubicin (DOX). Despite the early stage of development and a small number of participants, signs of meaningful clinical activity have emerged. Among the heavily pre-treated participants – including patients pre-treated with DOX – the median progression-free survival (PFS) following treatment with THE001 + RHT reached 4.5 months across both dose levels (20 and 40 mg/m²). This exceeds the typical median PFS of 2.7 to 3.5 months observed with first-line DOX therapy in treatment-naïve patients at DOX doses of 75 mg/m 2 , i.e., 2-4x higher than doses of THE001 applied in the Phase I setting. At dose level 2 (40 mg/m²), the mean PFS reached 7.1 months. Two out of three participants in this dose level achieved a partial response (PR) according to Choi criteria and completed the maximum extended treatment phase of 12 cycles (~8.3 months). Notably, one participant whose tumor was initially considered unresectable, could undergo surgical resection at the end of the extended study treatment. This participant showed a tumor shrinkage of -16% in the sum of target lesions, a partial response according to Choi criteria and no vital tumor cells in the resected target lesion. Across dose levels 1 and 2, THE001 + RHT demonstrated a favorable safety profile. There were no dose-limiting toxicities or high-grade treatment-related adverse events that led to treatment discontinuation, underscoring the good tolerability of THE001 in combination with RHT. “These findings not only provide consistent proof of the galenic concept of heat-triggered, largely complete DOX release from THE001, but also demonstrate clinical benefit in a highly challenging patient population,” said Dr. Frank Hermann, Chief Medical Officer of Thermosome. “We are particularly encouraged by the results of one participant who underwent resection after 12 full treatment cycles with THE001 and regional hyperthermia with no vital tumor cells found in the resected target lesion. These results clearly support future exploration in the neoadjuvant setting.” Alexander Eggermont, Professor of Clinical and Translational Immunotherapy, University Medical Center, Utrecht, and a member of Thermosome´s Clinical Advisory Board, commented: “The Phase I data of THE001, a thermosensitive liposomal DOX, and regional hyperthermia in heavily pre-treated DOX-experienced soft tissue sarcoma patients, particularly from dose level 2, are very encouraging. These results demonstrate the clinical potential of this highly innovative approach and provide the necessary foundation for transitioning into Phase II proof-of-concept development. I am excited to support this important work and look forward to advancing this promising therapy, which has the potential to significantly improve outcomes for patients with soft tissue sarcoma, particularly in the neoadjuvant setting.” “It is exciting to see the promising results of THE001 combined with regional hyperthermia, demonstrating strong potential to address the high unmet need for better treatments for soft tissue sarcoma,” added Prof. Shreyaskumar Patel, the Robert R. Herring Distinguished Professor of Medicine and Medical Director of the Sarcoma Center at The University of Texas MD Anderson Cancer Center, Houston Texas, and a member of Thermosome’s Clinical Advisory Board. ”Expansion into Phase II, also including the U.S., would offer a much-needed validation of this new therapeutic strategy for patients with STS. I look forward to supporting the advancement of this innovative treatment option to improve outcomes for patients here in the U.S. and globally on the back of the orphan drug designation granted by the FDA.” Considering supportive feedback from the German Federal Institute for Drugs and Medical Devices (BfArM) on the development of THE001 + RHT in the neoadjuvant setting, the available data from last-line participants are intended to support further development in the neoadjuvant setting. About Thermosome Thermosome is a clinical-stage drug development company focused on targeted tumor therapy combined with immune stimulation for improved cancer therapy. At its core is a novel, proprietary tumor targeting approach that allows for significantly increased local drug concentration and improved tumor penetration to achieve improved clinical treatment efficacy. The first clinical indication for its lead drug candidate THE001 is soft tissue sarcoma, where the Company aims to improve the current standard of care (free doxorubicin). Thermosome’s approach enables targeted tumor treatment independent of specific molecular targets and covers patient populations across all chemo-sensitive tumor subtypes. More information: www.thermosome.com About THE001 Thermosome’s clinical-stage lead drug candidate THE001 is a thermosensitive liposomal formulation of the chemotherapeutic drug doxorubicin (DPPG 2 -TSL-DOX). It has a different mode of action than conventional liposomes. Thermosome’s technology enables intravascular drug release initiated by a mild heat trigger using clinically established hyperthermia devices. This results in up to 15-fold higher local drug concentrations in the tumor and aims to improve clinical treatment efficacy by creating a local boost at the desired site of action. These high local concentrations, which also reach less well perfused areas, are intended to overcome drug resistance. This effect cannot be achieved by administration of conventional doxorubicin due to systemic toxicity. Thermosome intends to further enhance treatment efficacy through an additive immune response induced by regional hyperthermia. THE001 has potential for further development in other anthracycline-sensitive solid tumors, such as breast, bladder, and ovarian cancer. THE001 has been granted Orphan Drug Designation for STS in Europe and the United States. About the Phase I Study The Phase I, open-label, interventional dose-escalation trial enrolling patients with (including DOX-) pre-treated locally advanced unresectable or metastatic STS ( NCT05858710 ) is being conducted at two German clinical sites testing THE001 at various different dose levels in initially up to 6 cycles every 3 weeks with option to extend to up to 12 cycles in participants with at least disease control. Both completed dose level (20 mg/m² and 40 mg/m²) were well tolerated and declared safe by the independent data safety monitoring board (DSMB). Primary endpoints of the study are the safety and tolerability of THE001 and the determination of the maximum tolerated dose. A secondary objective is the evaluation of anti-tumor activity. Initial clinical data were presented at the CTOS 2024 Annual Meeting ( link ). About Soft Tissue Sarcomas (STS) STS is an atypical tumor with a patient population that includes many young patients. Locally advanced STS (LA-STS) are large invasive tumors that are difficult or impossible to resect. Neoadjuvant therapy is used to shrink these tumors preoperatively to allow tumor surgery with curative intent. Free doxorubicin in combination with ifosfamide or dacarbazine has been the gold standard for neoadjuvant therapy of all chemo-sensitive LA-STS for several decades. Guidelines also recommend combining DOX-based therapy with regional hyperthermia. However, with response rates of less than 30%, there is a significant unmet need for improved treatment options. Soft tissue sarcomas occur in more than 50 different subtypes that do not share a common driver mutation, making biologic targeting more difficult than physically controlled targeting with the most active agent. SOURCE: Thermosome

Phase 1Clinical ResultOrphan DrugImmunotherapyASCO

18 Jun 2025

·www.globenewswire.com

Genmab Announces Epcoritamab Investigational Combination Therapy Demonstrates High Response Rates in Patients with Relapsed or Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL) Eligible for Autologous Stem Cell Transplantation (ASCT)

June 15, 2025 Results from the EPCORE® NHL-2 trial show investigational treatment with epcoritamab in combination with rituximab, ifosfamide, carboplatin, and etoposide (R-ICE) led to an overall response rate (ORR) of 87 percent and a complete response (CR) rate of 65 percent in patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) Data further demonstrates the potential of epcoritamab in combination with salvage chemoimmunotherapy to increase the proportion of patients to qualify for Autologous Stem Cell Transplantation (ASCT) Data was presented during an oral session at the 30th European Hematology Association (EHA) Congress Genmab A/S (Nasdaq: GMAB) today announced new results from the Phase 1b/2 EPCORE® NHL-2 trial Arm 10 (NCT04663347), evaluating epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, in combination with rituximab, ifosfamide, carboplatin, and etoposide (R-ICE) in adult patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) who are eligible for autologous stem cell transplantation (ASCT). Results demonstrated an overall response rate (ORR) of 87 percent, a complete response (CR) rate of 65 percent and a partial response (PR) of 23 percent. The majority of patients (65 percent) proceeded to ASCT. At six months, an estimated 81 percent of responses were ongoing, 74 percent of patients were progression free, and 100 percent of patients were alive. These results were shared today during an oral presentation at the 30th European Hematology Association (EHA) 2025 Congress. The safety profile of this combination therapy showed cytokine release syndrome (CRS) being low grade and no discontinuations due to treatment-emergent adverse events (TEAEs). The most common TEAEs were neutropenia (74 percent), anemia (68 percent), and thrombocytopenia (68 percent). CRS occurred in 52 percent; all were low grade (1/2) and resolved. One patient had immune effector cell-associated neurotoxicity syndrome (ICANS; grade 1), which resolved. No clinical tumor lysis syndrome was observed. Infections occurred in 18 patients (58 percent); five (16 percent) had serious infections. There were no Grade 5 TEAEs. “These results are particularly encouraging because many of the patients in this study had high-risk disease, having progressed rapidly after initial treatment,” said Raul Cordoba, MD, PhD, Head of the Lymphoma Unit at the Fundacion Jimenez Diaz University Hospital, Madrid, Spain. “This combination therapy of epcoritamab plus rituximab, ifosfamide, carboplatin, and etoposide (R-ICE) offers a potential new treatment option for patients with relapsed/refractory diffuse large B-cell lymphoma, providing high response rates and a bridge to potentially curative autologous stem cell transplantation." Among patients in the study who progressed within 12 months after first-line treatment (n=20), epcoritamab in combination with R-ICE demonstrated an 85 percent ORR and 55 percent CR. Patients in the study who progressed after 12 months from first-line therapy experienced a 91 percent ORR and 82 percent CR. Additionally, patients with one prior line of therapy experienced an 88 percent ORR and 68 percent CR, and patients who were treated with more than one prior line of therapy experienced an 83 percent ORR and 50 percent CR. “The results from this trial highlight the potential of this investigational epcoritamab containing regimen, especially in patients who progress quickly after initial treatment, and reinforce our joint efforts with AbbVie to develop epcoritamab as a core therapy for B-cell lymphomas, especially as we develop epcoritamab in earlier lines of therapy and a broader patient population,” said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab. “Our comprehensive EPCORE clinical trial program is dedicated to advancing epcoritamab as both monotherapy and in combination to address the significant unmet need in relapsed/refractory diffuse large B-cell lymphoma and other hematologic malignancies." Use of epcoritamab + R-ICE in patients with R/R DLBCL eligible for ASCT is not approved and the safety and efficacy of epcoritamab for use as a combination therapy in DLBCL have not been established. DLBCL is the most common type of non-Hodgkin's lymphoma (NHL) worldwide, accounting for approximately 25-30 percent of all NHL cases. In the U.S., there are approximately 25,000 new cases of DLBCL diagnosed each year. DLBCL can arise in lymph nodes as well as in organs outside of the lymphatic system, occurs more commonly in the elderly and is slightly more prevalent in men. DLBCL is a fast-growing type of NHL, a cancer that develops in the lymphatic system and affects B-cell lymphocytes, a type of white blood cell. For many people living with DLBCL, their cancer either relapses, which means it may return after treatment, or becomes refractory, meaning it does not respond to treatment. Although new therapies have become available, treatment management can remain a challenge. EPCORE NHL-2 is a Phase 1b/2 open-label interventional trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics/biomarkers, immunogenicity, and preliminary efficacy of epcoritamab as a monotherapy and in combination with other standard of care agents in patients with B-cell non-Hodgkin’s lymphoma (B-NHL). The trial consists of two parts: Part 1 (Dose Escalation) and Part 2 (Dose Expansion). The primary objective of Part 1 is safety, and the primary goal of Part 2 is preliminary efficacy. The primary endpoint was overall response rate (ORR) based on best overall response per Lugano criteria. MRD negativity was assessed as a secondary endpoint. Arm 10 of the EPCORE NHL-2 study enrolled 31 patients with R/R DLBCL, who were eligible for R-ICE and ASCT, and had received ≥1 prior line of treatment. At the time of data cutoff (December 18, 2024), median follow-up was 11 months (range, 6−15). Among the 31 patients treated with epcoritamab 48 mg + R-ICE, 61 percent were Ann Arbor stage III/IV, 42 percent had bulky disease ≥7 cm, 81 percent had one prior LOT (range, 1−3), and 65 percent had progressed within 12 months of first-line treatment. Epcoritamab is an IgG1-bispecific antibody created using Genmab's proprietary DuoBody® technology and administered subcutaneously. Genmab's DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T-cell-mediated killing of CD20+ cells.i Epcoritamab (approved under the brand name EPKINLY® in the U.S. and Japan, and TEPKINLY® in the EU) has received regulatory approval in certain lymphoma indications in several territories. Where approved, epcoritamab is available as a readily accessible therapy without the need for reducing tumor burden (“debulking”). Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. Both companies will pursue additional international regulatory approvals for the investigational R/R FL indication and additional approvals for the R/R DLBCL indication. Genmab and AbbVie continue to evaluate the use of epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes five ongoing Phase 3, open-label, randomized trials including a trial evaluating epcoritamab as a monotherapy in patients with R/R DLBCL compared to investigators choice chemotherapy (NCT04628494), a trial evaluating epcoritamab in combination with R-CHOP in adult patients with newly diagnosed DLBCL (NCT05578976), a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) in patients with R/R FL (NCT05409066), a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) compared to chemoimmunotherapy in patients with previously untreated FL (NCT06191744), and a trial evaluating epcoritamab in combination with R2 compared to chemotherapy infusion in patients with R/R DLBCL (NCT06508658). The safety and efficacy of epcoritamab has not been established for these investigational uses. Genmab is an international biotechnology company with a core purpose of guiding its unstoppable team to strive toward improving the lives of patients with innovative and differentiated antibody therapeutics. For 25 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with knock-your-socks-off (KYSO®) antibody medicines. Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with international presence across North America, Europe and Asia Pacific. The content above comes from the network. if any infringement, please contact us to modify.

$Genmab Announces Epcoritamab Investigational Combination Therapy Demonstrates High Response Rates in Patients with Relapsed or Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL) Eligible for Autologous Stem Cell Transplantation (ASCT)$

Clinical ResultImmunotherapyDrug Approval

14 May 2025

·www.globenewswire.com

Genmab to Present New and Updated Results from its Robust Epcoritamab (EPKINLY®) Development Program at the 2025 European Hematology Association (EHA) Congress

Media ReleaseCOPENHAGEN, Denmark; May 14, 2025 Data from 14 abstracts highlight the depth, breadth, and strength of Genmab’s comprehensive epcoritamab development program across multiple patient populations and treatment settings Genmab A/S (Nasdaq: GMAB) announced today that it will present 14 abstracts evaluating epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, as a monotherapy and in combination across disease settings in patients with diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) at the 30th European Hematology Association (EHA) Congress, being held in Milan, Italy, and virtually, June 12-15, 2025. Two oral presentations will feature data from the Phase 1/2 EPCORE® NHL-2 trial evaluating epcoritamab plus rituximab and ifosfamide-carboplatin-etoposide (R-ICE) in patients with relapsed/refractory (R/R) DLBCL eligible for autologous stem cell transplantation, and the Phase 1/2 EPCORE NHL-5 trial evaluating epcoritamab plus polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone (pola-R-CHP) in previously-untreated patients with DLBCL. Additionally, results from the Phase 1/2 EPCORE NHL-1 and NHL-3 trials, including three years of follow-up in patients with R/R DLBCL and FL treated with epcoritamab monotherapy, will be presented as a poster. All abstracts accepted for presentation have been published and may be accessed online via the EHA Open Access Library. “Together with AbbVie, we have made tremendous progress advancing our broad epcoritamab development program and we are pleased to share important results at EHA 2025 evaluating epcoritamab in a variety of treatment settings and patient populations,” said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab. “The data presented at EHA further reinforce our commitment to epcoritamab and its potential to become a core therapy across B-cell malignancies.” Several abstracts evaluating epcoritamab will also be presented at the 18th International Conference on Malignant Lymphoma (ICML), taking place June 17-21, 2025, in Lugano, Switzerland. Abstracts accepted for presentation at EHA include: Abstract Number Abstract Title Type of Presentation Date/Time of Presentation S245First Disclosure of Epcoritamab + R-ICE in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL) Eligible for Autologous Stem Cell Transplantation (ASCT): EPCORE NHL-2OralSunday, June 1511:00-12:15 CESTS247Durable Efficacy with Fixed-Duration Epcoritamab + Polatuzumab Vedotin, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (Pola-R-CHP) for 1L Diffuse Large B-cell Lymphoma (EPCORE NHL-5)OralSunday, June 1511:00-12:15 CESTPF881Epcoritamab Monotherapy Demonstrates Deep and Durable Responses at Three-Year follow-up in Patients with Relapsed/Refractory Follicular LymphomaPosterFriday, June 13 18:30-19:30 CESTPF885Epcoritamab Plus Lenalidomide and Rituximab Achieves High Response Rates and Survival Benefits Compared with Usual Care in Relapsed/Refractory Follicular Lymphoma: A Comparative AnalysisPosterFriday, June 13 18:30-19:30 CESTPF920Sustained Remission in R/R DLBCL with Epcoritamab Monotherapy: EPCORE NHL-1 3y Results and Novel Subgroup Analyses in Patients with Complete Response at 2yPosterFriday, June 13 18:30-19:30 CESTPS1886Matching-Adjusted Indirect Comparison of Epcoritamab with Rituximab + Lenalidomide vs Tafasitamab with Rituximab + Lenalidomide in Second-Line+ Follicular LymphomaPosterSaturday, June 14 18:30-19:30 CESTPS1898Patient-Reported Outcomes in Patients with Relapsed/Refractory Follicular Lymphoma Treated with Epcoritamab within the Entire Study Cohort and in Patients with Symptoms at BaselinePosterSaturday, June 14 18:30-19:30 CESTPS1968Match-Adjusted Comparative Analysis of Epcoritamab + R-DHAX/C or R-ICE vs R-DHAX/C or R-ICE In 2L+ Transplant-Eligible Patients with Diffuse Large B-Cell LymphomaPosterSaturday, June 14 18:30-19:30 CESTPS1942Match-Adjusted Comparative Analysis of the Efficacy Of Epcoritamab + R-Mini-CHOP vs R-Mini-CHOP in Previously Untreated Diffuse Large B-Cell LymphomaPosterSaturday, June 14 18:30-19:30 CESTPS1932Treatment Outcomes in Newly Diagnosed Diffuse Large B-Cell Lymphoma Patients with High Cardiovascular Risk, and Treated with Non-Anthracycline Containing RegimensPosterSaturday, June 14 18:30-19:30 CESTPS1944Patient Preferences for Attributes of Bispecific Antibodies Indicated for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma in the United StatesPosterSaturday, June 14 18:30-19:30 CESTPS1912Circulating Tumour DNA-Directed Intervention with Epcoritamab Alone or in Combination with Lenalidomide and Rituximab is Feasible in the Early Post-CAR-T Population at High Risk of Relapse: Preliminary Data from EpLCARTPosterSaturday, June 14 18:30-19:30 CESTPS1979Epcoritamab with Gemcitabine, Dexamethasone, and Cisplatin (Epco-GDP) in Relapsed, Refractory Large B-cell Lymphoma – An Interim Analysis of Phase II Multicenter Investigator-initiated TrialPosterSaturday, June 1415:30-16:00 CESTPS1892Phase II Investigator-initiated Trial of Epcoritamab-Lenalidomide in Treatment Naïve Follicular LymphomaPosterSaturday, June 14 18:30-19:30 CEST The safety and efficacy of these investigational uses have not been established. About Epcoritamab Epcoritamab is an IgG1-bispecific antibody created using Genmab's proprietary DuoBody® technology and administered subcutaneously. Genmab's DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T-cell-mediated killing of CD20+ cells.i Epcoritamab (approved under the brand name EPKINLY® in the U.S. and Japan, and TEPKINLY® in the EU) has received regulatory approval in certain lymphoma indications in several territories. Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. Both companies will pursue additional international regulatory approvals for the investigational R/R FL indication and additional approvals for the R/R DLBCL indication. Genmab and AbbVie continue to evaluate the use of epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes five ongoing Phase 3, open-label, randomized trials including a trial evaluating epcoritamab as a monotherapy in patients with R/R DLBCL compared to investigators choice chemotherapy (NCT04628494), a trial evaluating epcoritamab in combination with R-CHOP in adult patients with newly diagnosed DLBCL (NCT05578976), a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) in patients with R/R FL (NCT05409066), a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) compared to chemoimmunotherapy in patients with previously untreated FL (NCT06191744), and a trial evaluating epcoritamab in combination with lenalidomide compared to chemoimmunotherapy in patients with R/R DLBCL (NCT06508658). The safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit www.clinicaltrials.gov for more information. About Genmab Genmab is an international biotechnology company with a core purpose of guiding its unstoppable team to strive toward improving the lives of patients with innovative and differentiated antibody therapeutics. For more than 25 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with knock-your-socks-off (KYSO) antibody medicines®.  Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X. Contact: David Freundel, Senior Director, Product CommunicationsT: +1 609 613 0504; E: dafr@genmab.com Andrew Carlsen, Vice President, Head of Investor RelationsT: +45 3377 9558; E: acn@genmab.comThis Media Release contains forward looking statements. The words “believe,” “expect,” “anticipate,” “intend” and “plan” and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with preclinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on www.genmab.com and the risk factors included in Genmab’s most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Media Release nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law. Genmab A/S and/or its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®; HuMax®; DuoBody®; HexaBody®; DuoHexaBody®, HexElect® and KYSO®. EPCORE®, EPKINLY®, TEPKINLY® and their designs are trademarks of AbbVie Biotechnology Ltd. i Engelberts PJ, et al. DuoBody-CD3xCD20 Induces Potent T-Cell-Mediated Killing of Malignant B Cells in Preclinical Models and Provides Opportunities for Subcutaneous Dosing. EBioMedicine. 2020;52:102625. doi: 10.1016/j.ebiom.2019.102625. Media Release no. i08CVR no. 2102 3884LEI Code 529900MTJPDPE4MHJ122 Genmab A/SCarl Jacobsens Vej 302500 ValbyDenmark Attachment 140525_MRi08_EHA Curtain Raiser

ImmunotherapyClinical ResultPhase 3Phase 2Drug Approval

100 Deals associated with Ifosamide

External Link

KEGG	Wiki	ATC	Drug Bank
D00343	Ifosamide	L01AA06	DB01181

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Bone Tissue Neoplasms	Japan	Shionogi & Co., Ltd.	14 Feb 2005
Childhood Malignant Solid Neoplasm	Japan	Shionogi & Co., Ltd.	14 Feb 2005
Gonadal Tissue Neoplasms	Japan	Shionogi & Co., Ltd.	14 Dec 2004
Hemorrhagic cystitis	United States	Baxter Healthcare Corp.	14 Aug 1987
Osteosarcoma	Japan	Shionogi & Co., Ltd.	16 Apr 1985
Prostatic Cancer	Japan	Shionogi & Co., Ltd.	16 Apr 1985
Small Cell Lung Cancer	Japan	Shionogi & Co., Ltd.	16 Apr 1985
Uterine Cervical Cancer	Japan	Shionogi & Co., Ltd.	16 Apr 1985
Breast Cancer	France	Baxter International, Inc.	01 Jan 1976
Lung Cancer	France	Baxter International, Inc.	01 Jan 1976
Lymphoma	France	Baxter International, Inc.	01 Jan 1976
Ovarian Cancer	France	Baxter International, Inc.	01 Jan 1976
Sarcoma	France	Baxter International, Inc.	01 Jan 1976
Testicular Neoplasms	France	Baxter International, Inc.	01 Jan 1976

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Refractory Osteosarcoma	Phase 2	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	01 Mar 2022
Toxicity	Phase 2	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	01 Mar 2022
Locally Advanced Soft Tissue Sarcoma	Phase 2	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	20 Aug 2019
Chondrosarcoma	Preclinical	France	Atlanthera SASU	27 Jul 2018
Ewing Sarcoma	Preclinical	France	Atlanthera SASU	14 Jul 2018

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESMO2025	Not Applicable	Enteropathy-Associated T-Cell Lymphoma	56	mNewcastle regimen	wflflwcuhm(ocwmkpigkt) = xntajtmavg mofqvcrhwd (qjxwonatov ) View more	Positive	17 Oct 2025
				CHOP-like regimens	wflflwcuhm(ocwmkpigkt) = igdvuobarf mofqvcrhwd (qjxwonatov ) View more
NCT00878254 (CTgov)	Phase 2	Mantle-Cell Lymphoma	25	Mesna+Etoposide+Cyclophosphamide+Leucovorin+G-CSF+Doxorubicin+ifosfamide+Methotrexate+Rituximab+Vincristine+Cytarabine	gsqsdvkjkm(jdjtuqhcok) = uiofomrqgk wsfdlvrrlo (wjueayevzz, jdglkhvgoo - tlbhqqbiuo) View more	-	23 Jul 2025
NCT05784987 (EHA2025) Manual	Phase 2	Diffuse Large B-Cell Lymphoma TP53 Mutation \| BCL7A Rearrangement	47	R-MINE+X regimen	prjmsccrsb(xgzyzqdqbw) = lmtbgzivpa oabqfiilst (uzsjljgmrj ) View more	Positive	14 May 2025
				R-MINE+MCD/BN2	prjmsccrsb(xgzyzqdqbw) = vledawnchs oabqfiilst (uzsjljgmrj ) View more
PB3829 (EHA2025)	Phase 2	Diffuse Large B-Cell Lymphoma	12	R-MINE (rituximab, ifosfamide, mitoxantrone, and etoposide)	xbgsbvkiqa(mbhlamcthp) = relatively complex vwzzsjuwso (ywnypkgsvy )	-	14 May 2025
PB3141 (EHA2025)	Phase 2	Hodgkin's Lymphoma	33	Nivolumab + Ifosfamide + Carboplatin + Etoposide (NICE)	tnwfbxhyxi(dgtwuoalxj) = orjsgrthzv mfcyudocye (fufbjfnoqg, 0 - 9.9) View more	Positive	14 May 2025
				IGEV regimen (gemcitabine, ifosfamide, vinorelbine, methylprednisolone)	tnwfbxhyxi(dgtwuoalxj) = qwcorpcndm mfcyudocye (fufbjfnoqg, 5.11 - 37.5) View more
ASCO_GU2025	Not Applicable	Urethral Neoplasms	18	Paclitaxel, Ifosfamide, Cisplatin (TIP) regimen	yteeaxgkrv(lsqnvdorjs) = yeemxqtujt qacpnhxpup (rnyxknztmr ) View more	Positive	13 Feb 2025
ESMO2024 Manual	Phase 2	Nonseminomatous Germ Cell Tumor	34	Paclitaxelnifosfamidecisplatin	hcyohnrljf(flewyimecf) = dgmwhldtty kkjcgksvcy (sovlyjuceq ) View more	Negative	15 Sep 2024
NCT02375204 (TIGER, Pubmed) Manual	Phase 2	Germ Cell and Embryonal Neoplasms Second line	104	Paclitaxel, IIfosfamide anCisplatinin (TIP)	ybcfgigzpn(ohmbuoysee) = ilmrgyqlia vnfuwrtcno (nudpilvsrz, 59 - 77) View more	Positive	19 Jul 2024
				Paclitaxel + Ifosfamide + Cisplatin (patients had favorable risk factors)	ybcfgigzpn(ohmbuoysee) = rwhktbucvm vnfuwrtcno (nudpilvsrz, 61 - 80) View more
NCT04947501 (N9, ASCO2024) Manual	Early Phase 1	High Risk Neuroblastoma	15	cyclophosphamidehostopotecanopovincristineistifosfamidecarboplatinetoposide	btzqzsacce(bokkvpocav) = drooeemtvj dqhoipqysl (fqbutduiqa ) View more	Positive	24 May 2024
				cyclophosphamideplatopotecansidvincristineifosfamidecarboplatinetoposide	aljtdifxnu(lnempwslfn) = srmwsmoigi lnjgnoclfj (qvuwnphkfn ) View more
NCT01959698 (CORAL, ASCO2024)	Phase 1/2	Diffuse large B-cell lymphoma recurrent Bcl-2 family members	-	Carfilzomib plus rituximab, ifosfamide, carboplatin and etoposide (C-RICE)	vbgslmbibk(lnqfgsjzxv) = bajlzexpoo ppdlhdtiza (svcvvlgwyt ) View more	Positive	24 May 2024
				RICE	vbgslmbibk(lnqfgsjzxv) = rvknrzdbax ppdlhdtiza (svcvvlgwyt ) View more

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