A Phase 1b Trial of Adaptive Stereotactic Body Radiotherapy in Combination With Durvalumab (MEDI4736), Platinum, and Etoposide in Extensive Stage Small Cell Lung Cancer

This is trial studying the safety of adaptive stereotactic body radiotherapy (SBRT) combined with durvalumab immunotherapy, platinum chemotherapy, and etoposide chemotherapy in platinum refractory extensive stage small cell lung cancer (SCLC).

Start Date31 Dec 2025

Sponsor / Collaborator

University of Maryland Baltimore

[+1]

NCT07001995

/ Not yet recruitingPhase 2IIT

A Single-center, Single-arm Phase II Study of Limertinib Plus Carboplatin and Etoposide in EGFR-mutant NSCLC Patients With SCLC Transformation After EGFR-TKI Progression

This single-center, prospective study and aims to evaluate the efficacy and safety of limertinib combined with etoposide and carboplatin in EGFR-mutant NSCLC patients who develop small-cell lung cancer transformation following progression on EGFR-TKI therapy.

Start Date01 Oct 2025

Sponsor / Collaborator

Hunan Cancer Hospital

NCT06769126

/ Not yet recruitingPhase 2IIT

PRISM: PRecIsion in SCLC Via a Multicohort Study: Randomized Phase II Studies Evaluating Maintenance Durvalumab With or Without Biomarker-Directed Therapy for Extensive Stage Small Cell Lung Cancer (ES-SCLC)

This phase II trial tests how well biomarker tests on patients tumor tissue works in selecting personalized treatments for patients with extensive stage small cell lung cancer (ES-SCLC). Biomarker tests look for certain features in cancer cells that may give doctors more information about what is driving cancer and how to treat it. Based on the biomarker test results, study doctors can determine the subtype of ES-SCLC that study treatments can target. This study also tests different types of maintenance treatment for ES-SCLC with drugs durvalumab, saruparib, ceralasertib or monalizumab. Maintenance treatment is given after initial treatment and is given to help keep the cancer under control and prevent it from getting worse. Immunotherapy with monoclonal antibodies, such as durvalumab and monalizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Saruparib is a PARP inhibitor. PARP is a protein that helps repair damaged deoxyribonucleic acid (DNA). Blocking PARP may prevent cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Ceralasertib may stop the growth of tumor cells and may kill them by blocking some of the enzymes needed for tumor cell growth. Giving biomarker selected personalized maintenance treatment with durvalumab, saruparib, ceralasertib or monalizumab may work better in treating patients with ES-SCLC.

Start Date08 Sep 2025

Sponsor / Collaborator

SWOG

[+1]

100 Clinical Results associated with Etoposide

100 Translational Medicine associated with Etoposide

100 Patents (Medical) associated with Etoposide

35,682

Literatures (Medical) associated with Etoposide

31 Dec 2025·NMC case report journal

A Primary Spinal Intramedullary Mixed Germ Cell Tumor: A Case Report and Literature Review

Article

Author: SHIMAUCHI-OHTAKI, Hiroya ; HORIGUCHI, Keishi ; HIRATO, Junko ; NAKATA, Satoshi ; HONDA, Fumiaki ; YOKOO, Hideaki ; OYA, Soichi ; GOTO, Yuta ; TOMOMASA, Ran ; NAKAMURA, Shunsuke

Central nervous system germ cell tumors are rare and account for 2% to 3% of all central nervous system tumors in Japan. Here, we report an extremely rare case of a primary spinal intramedullary mixed germ cell tumor. A 33-year-old man presented with a chief report of dysuria and numbness in the right lower extremity. Magnetic resonance imaging revealed a mass lesion on the left side of the intramedullary spinal cord at the Th10-11 vertebral body level with hyperintensity on T2-weighted images, isointensity on T1-weighted images, and uniform contrast in gadolinium. Cerebrospinal fluid examination revealed a few atypical cells. Although tumor removal using the posterior median sulcus approach was attempted, only a biopsy was performed because intraoperative rapid pathology suggested a possible diagnosis of germinoma. Permanent pathology revealed a mixed germ cell tumor (mainly comprising a germinoma with a yolk sac tumor). Postoperatively, cerebrospinal irradiation and 8 courses of the carboplatin and etoposide regimen were administered. No recurrence or new lesions were observed on magnetic resonance imaging at 94 months postoperatively. Our extensive literature search found only 4 cases of a mixed germ cell tumor of primary intramedullary origin in the spinal cord. Most spinal germ cell tumors described in the literature are either germinomas or mature teratomas; however, mixed germ cell tumors can also occur, albeit infrequently. Although additional cases need to be accumulated, our case suggests that yolk sac elements in spinal mixed germ cell tumors might not be directly associated with poor life expectancy.

31 Dec 2025·JOURNAL OF ENZYME INHIBITION AND MEDICINAL CHEMISTRY

Synthesis, in vitro and in silico studies of a novel chrysin-ferrocene Schiff base with potent anticancer activity via G1 arrest, caspase-dependent apoptosis and inhibition of topoisomerase II

Article

Author: Break, Mohammed Khaled Bin ; Alkahtani, Hamad M. ; Ansari, Siddique Akber ; Alshammari, Maali D. ; Katamesh, Ahmed A. ; Albadari, Najah

A novel chrysin-ferrocene Schiff base (CFSB) was synthesised as a potential anticancer agent. CFSB demonstrated high cytotoxicity against cancer cells with HepG2 (liver) being the most susceptible (IC₅₀ = 3.11 µM). The compound was less toxic towards normal MRC5 cells and exhibited ∼5-fold selectivity towards most cancer cells. CFSB caused G1-phase arrest, induced caspase-dependent apoptosis by increasing Bax/Bcl2 ratio and reduced metastasis by decreasing MMP9 in HepG2. Furthermore, CFSB was inactive against CDK2, EGFR, TrkA and VEGFR, but it strongly inhibited topoisomerase II (IC₅₀ = 20 µM) with potency comparable to etoposide (IC₅₀ = 15 µM), while weak inhibition was observed against tubulin (IC₅₀ = 76 µM). DFT calculations revealed that CFSB had desirable reactivity, while docking indicated high binding affinity with topoisomerase II. Molecular dynamics and MM-GBSA analyses showed that CFSB-topoisomerase II complex was stable with favourable binding energies, while in silico ADMET studies showed drug-like properties for CFSB.

31 Dec 2025·ANNALS OF MEDICINE

Construction of a novel prognostic model based on lncRNAs-related to DNA damage repair for predicting the prognosis of clear cell renal cell carcinoma

Article

Author: Chen, Peng ; Li, Jian ; Tian, Renli

BACKGROUND:

CcRCC has the characteristics of high aggression, high metastasis, high mortality, wide tumour heterogeneity and variable clinical course. The purpose of this study was to explore the potential value of lncRNAs-related to DNA damage repair (DDR) in predicting the prognosis of ccRCC by construction and verification a novel prognostic model.

METHODS:

RNA-seq data and clinical data of ccRCC were downloaded from public databases. Subsequently, Pearson correlation analysis and differential expression analysis were performed to identify DElncRNAs-related to DDR. Then, through univariate Cox analysis and LASSO analysis, the DElncRNAs-related to DDR associated with prognosis were screened for the construction of novel risk score prognostic model. In addition, functional annotation, tumour mutation burden, immune correlation and drug sensitivity analyses were performed based on risk score to assess the characteristics of patients in different risk score groups.

RESULTS:

Based on univariate Cox analysis and LASSO analysis, four best DElncRNAs-related to DDR were selected. Subsequently, a novel risk score prognostic model based on these four DElncRNAs was constructed through LASSO. Multivariate Cox analysis showed that risk score and age were independent prognostic factors for ccRCC (p < 0.05). Functional enrichment analysis showed that DDR-related biological processes were mainly enriched in the high risk group. The highly mutated genes in the high and low risk groups were the same (VHL, PBRM1 and TTN), but they also had their own unique mutated genes. Pearson correlation analysis showed that the risk score was significantly (p < 0.05) positively correlated with the infiltration degree of CD8 T cells evaluated by six algorithms. In addition, it was found that the high and low risk groups had different sensitivities to the drugs Etoposide, Imatinib, Sorafenib, Bosutinib and Sunitinib.

CONCLUSION:

A novel prognostic model was constructed based on four DElncRNAs-related to DDR. The model has satisfactory accuracy in predicting survival of ccRCC patients.

292

News (Medical) associated with Etoposide

07 Jul 2025

·www.prnewswire.com

Precision Genetic Medicine Platform Could Disrupt Standard of Care in Metastatic Cancer, Other Indications of Unmet Needs

NetworkNewsWire Editorial Coverage NEW YORK, July 7, 2025 /PRNewswire/ -- An estimated 20 million people are diagnosed annually with cancer, while cancer kills almost 10 million people a year worldwide () with these numbers expected to grow. The American Cancer Society projects that by 2050, 35 million people will be diagnosed with cancer every year. Despite significant progress made in treating the disease, there is still a desperate need — and an enormous market potential — for new and more effective cancer drugs. Calidi Biotherapeutics Inc. (NYSE American: CLDI) (Profile) is committed to developing a novel approach to treating cancer through the precise delivery of genetic medicines to both primary tumors and metastatic sites of disease. This cutting-edge platform, which harnesses engineered viruses that can target sites of cancer in the body and deliver potent genetic medicines to attack tumors, has the potential to revolutionize the way cancer is treated. And while cancer is the initial focus for Calidi, the company has also begun to assess the potential of this technology in other areas of large unmet need such as autoimmune disease. Calidi is joining an elite group of high-quality companies focused on making a difference in the world of cancer and genetic medicines, including Regeneron Pharmaceuticals Inc. (NASDAQ: REGN), CG Oncology Inc. (NASDAQ: CGON), Roche (OTCQX: RHHBY) and Merck & Co. Inc. (NYSE: MRK). Cancer remains one of the most devastating health challenges facing the globe today, responsible for about one in six deaths worldwide. Calidi's decade-long development journey has culminated in novel precision genetic medicine delivery platforms with real therapeutic promise. The company has taken a decisive step in the fight against advanced and hard-to-treat cancers with CLD-401, its first compound designed for systemic administration that delivers IL-15 superagonist directly to tumor sites, including metastatic cancers . Calidi Biotherapeutics has unveiled compelling preclinical data this year at two of the most influential oncology conferences. Click here to view the custom infographic of the Calidi Biotherapeutics Inc. editorial. Sustained Investment in Research, Development Cancer remains one of the most devastating health challenges facing the globe today, responsible for about one in six deaths worldwide (). The most common cancer types worldwide include lung cancer (accounting for around 2.2 million new cases and 1.8 million deaths in 2020), breast cancer (2.26 million new cases), colorectal cancer (1.93 million) and prostate cancer (1.41 million). In the United States, cancer claims more than 600,000 lives each year, with more than two million new cases expected in 2025 alone. These figures highlight both the scale of human suffering and the enormous burden cancer places on health systems around the world. These statistics underscore the importance of sustained investment in research and development. The global oncology drugs market was valued at approximately $190.1 billion in 2023 and is projected to grow to more than $564.5 billion by 2033, reflecting a compound annual growth rate (CAGR) of 11.5% over the forecast period (). This rapid expansion highlights the critical role of sustained investment in research and development, which drives advancements in early detection, targeted therapies, immunotherapies and personalized medicine — key tools in reducing the overwhelming global cancer burden Advancing Precision Delivery of Genetic Medicines Calidi Biotherapeutics Inc (NYSE American: CLDI) has spent more than a decade developing a breakthrough technology platform that enables the systemic delivery of genetic medicines to targeted tumor sites, including metastatic sites in cancer patients. At the core of this innovation is the company's proprietary engineered viral system, which cloaks therapeutic payloads in a protective human cell membrane (the "envelope") designed to evade the immune system and reach distant metastases with precision where genetic medicines that can drive tumor clearance are expressed. Calidi's decade-long development journey, from stem cell-based delivery systems to the enveloped systemic virotherapies, has culminated in novel precision genetic delivery platforms with real therapeutic promise. The company's preclinical breakthroughs have been detailed in peer-reviewed conferences and investor communications, leading to upcoming IND filing goals and potential partnerships on the horizon. Calidi appears to be well positioned to pioneer a new era of targeted cancer treatment, where genetic payloads reach disease sites directly, immune activation is localized, and patients benefit from safer, more effective therapies. Understanding the Platform Calidi Biotherapeutics is clinical stage biotechnology company that is developing genetic medicines and proprietary genetically engineered oncolytic viruses. Calidi's RedTail systemic antitumor virotherapy platform is a novel tumor-selective vaccinia virus strain designed to target all tumor sites (). The platform is capable of producing a high amount of enveloped vaccinia viruses resistant to humoral immunity. The technology allows the therapy to reach tumor sites and kill tumors by expressing genetic medicines in the tumor microenvironment. According to the company, the lead candidate from the RedTail platform, CLD-401, targets lung cancer and other tumor types with high unmet medical need. Pioneering Systemic Cancer Targeting Calidi Biotherapeutics has taken a decisive step in the fight against advanced and hard-to-treat cancers with CLD-401, its first compound designed for systemic administration. This lead candidate harnesses the company's decade-long innovation in enveloped viral delivery to simultaneously destroy cancer cells and deliver genetic medicine aimed at preventing disease recurrence at metastatic sites. By enabling intravenous administration, CLD–401 ushers in a new era of precision oncology where genetic payloads reach tumors throughout the body, rather than relying on localized injections. Central to CLD–401's mechanism is the company's proprietary RedTail platform. CLD–401 is an enveloped oncolytic vaccinia virus engineered to express a chimeric CD55 receptor, significantly enhancing its resistance to immune clearance and enabling systemic circulation to metastatic tumors. Loaded with an IL–15 superagonist payload, the virus not only lyses tumor cells but also delivers powerful genetic material directly into the tumor. This cytokine-based genetic medicine activates CD8+ T cells and natural killer cells, effectively transforming "cold" tumors into immunologically "hot" targets. Preclinical data has confirmed the platform's potential. "Of particular excitement is the rapid progress we have made with RedTail, the company's approach to systemically delivering genetic medicines to metastatic sites in patients with advanced cancer using our proprietarily engineered enveloped virus," reported Calidi CEO Dr. Eric Poma in a recent shareholder letter (). "RedTail represents the culmination of over a decade of meticulous research and innovation at Calidi to create what we believe is the most advanced systemic virotherapy platform. Advancing this novel platform is the company's main focus and priority." Sharing Compelling Preclinical Data Calidi Biotherapeutics has unveiled compelling preclinical data at two of the most influential oncology conferences — the American Association of Cancer Research (AACR) and the American Association of Clinical Oncology (ASCO) — highlighting the tumor-clearing and recurrence-blocking potential of CLD–401. At the AACR Annual Meeting, held in April 2025, Calidi presented key findings under the title "Development of a Systemic Enveloped Virotherapy for Targeting All Metastatic Sites" (). The data revealed that RedTail's enveloped vaccinia virus, coated with a human-like extracellular envelope, can survive immune defenses, access multiple tumor sites following intravenous administration and induce strong tumor killing even in traditionally hard-to-treat metastatic lung models, by delivering genetic medicines such as IL-15 superagonist directly to the tumor. The abstract emphasized the platform's ability to evade complement activation, substantially improving systemic circulation time and therapeutic impact. The momentum continued into the ASCO Annual Meeting in June 2025, where Calidi presented results demonstrating that CLD–401, enhanced with a chimeric CD55 receptor, further resists immune clearance and delivers its IL-15 superagonist payload directly into tumors (). This immune payload triggered robust expansion of CD8+ T cells and natural killer cells in the tumor microenvironment, key players in sustained anti-tumor immunity. Collectively, these data sets presented at AACR and ASCO illustrate the dual potency of CLD–401: it both breaks down tumor tissue and educates the immune system to prevent relapse. The systemic reach of RedTail, along with its tumor-targeted immune stimulation, positions Calidi's platform as a significant advancement in the field of immuno-oncology, especially for metastatic cancers with high unmet needs. "Looking ahead, our roadmap for the next 18 months includes multiple critical milestones," said Poma. "We are working to complete IND-enabling studies ahead of an IND filing by the end of 2026 for our lead RedTail candidate that delivers IL-15 superagonist to tumor sites, CLD-401. Our clinical strategy includes an optimized dose-escalation study designed to swiftly demonstrate efficacy and validate the systemic administration of RedTail in patients with metastatic disease." With promising results in hand and strategic plans in place, Calidi is positioning itself to enter human trials that may redefine how genetic medicines reach and treat cancer throughout the body. Leading Biotech Firms Share Promising Advances The global effort to transform cancer care continues to accelerate as leading biopharmaceutical companies report groundbreaking clinical data across multiple tumor types. Industry leaders are showcasing the progress of novel immunotherapies and targeted treatments aimed at some of the most challenging cancers. Regeneron Pharmaceuticals Inc. (NASDAQ: REGN) shared new and updated data from its oncology and hematology portfolio at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting (). According to the company, its 18 presentations will share the latest insights from ongoing research of approved and investigational treatment regimens across a range of difficult-to-treat cancers including non-melanoma and melanoma skin cancer, lung cancer, lymphoma and multiple myeloma. CG Oncology Inc . (NASDAQ: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients with bladder cancer, presented key data at the 2025 American Urological Association (AUA) Annual Meeting (). The data was from the phase 3 BOND-003 Cohort C study of patients with high-risk non-muscle invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette Guerin (BCG) treatment with carcinoma in situ (CIS) with or without Ta or T1 disease. Roche (OTCQX: RHHBY) is reporting positive results from its phase 3 IMforte study of Tecentriq(R) (atezolizumab) in combination with lurbinectedin (Zepzelca(R)) as a first-line maintenance treatment for people with extensive-stage small cell lung cancer (ES-SCLC), following induction therapy with carboplatin, etoposide and Tecentriq (). The company noted that the data showed that this combination reduced the risk of disease progression or death by 46% and the risk of death by 27%, compared to Tecentriq maintenance therapy alone. Merck & Co. Inc. (NYSE: MRK) announced that its phase 3 KEYNOTE-B96 trial, also known as ENGOT-ov65, met its primary endpoint of progression-free survival (PFS) for the treatment of patients with platinum-resistant recurrent ovarian cancer whose tumors expressed PD-L1 and in all comers (). The study also met a secondary endpoint of overall survival (OS) in patients whose tumors express PD-L1. The study is evaluating KEYTRUDA(R) (pembrolizumab), Merck's anti-PD-1 therapy, in combination with chemotherapy (paclitaxel) with or without bevacizumab for these patients. Together, these data presentations and reports underscore the power of innovation in oncology, where immunotherapy combinations, genetic medicine therapies and personalized treatment approaches are driving new standards of care. With each development, the cancer research community moves one step closer to achieving more durable responses, longer survival and, ultimately, potential cures. For more information, visit Calidi Biotherapeutics Inc. (NYSE American: CLDI). About NetworkNewsWire NetworkNewsWire ("NNW") is a specialized communications platform with a focus on financial news and content distribution for private and public companies and the investment community. It is one of 70+ brands within the Dynamic Brand Portfolio @ IBN that delivers : (1) access to a vast network of wire solutions via InvestorWire to efficiently and effectively reach a myriad of target markets, demographics and diverse industries ; (2) article and editorial syndication to 5,000+ outlets ; (3) enhanced press release enhancement to ensure maximum impact ; (4) social media distribution via IBN to millions of social media followers ; and (5) a full array of tailored corporate communications solutions. 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NetworkNewsWire New York, NY 212.418.1217 Office [email protected] SOURCE NetworkNewsWire WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultImmunotherapyPhase 3ASCO

02 Jul 2025

·pmlive.com

CHMP recommends tablet formulation of BeOne’s targeted cancer drug Brukinsa

The European Medicines Agency’s human medicines committee has recommended approval of a new tablet formulation of BeOne Medicines’ targeted blood cancer drug Brukinsa (zanubrutinib) . The company formerly known as BeiGene announced that the Committee for Medicinal Products for Human Use (CHMP) has recommended that the new formulation be approved for all indications covered by the original capsule version of its Bruton’s tyrosine kinase (BTK) inhibitor. This includes certain cases of Waldenström’s macroglobulinaemia, marginal zone lymphoma, chronic lymphocytic leukaemia and follicular lymphoma. The CHMP’s positive opinion was based on positive results from two phase 1 crossover studies of healthy adults, which demonstrated that Brukinsa tablets have the same efficacy and safety as Brukinsa capsules. The new formulation will allow patients able to take two 160mg tablets a day rather than four of the current 80mg capsules, offering a simplified dosing experience. The tablets are also smaller and have a film coating, making them easier to swallow. The European Commission will now review the CHMP’s recommendation as it makes a final decision on Brukinsa tablets, expected later this year. Giancarlo Benelli, senior vice president and head of Europe at BeOne, said: “The CHMP’s positive opinion of our new tablet formulation of Brukinsa is an important step toward bringing this thoughtful, patient-centred innovation to people facing certain B-cell cancers across Europe. “We look forward to a potential approval later this year and remain committed to delivering our impactful medicines to more patients in the region.” The recommendation comes less than two months after BeOne’s Tevimbra (tislelizumab) was approved by the EC in combination with etoposide and platinum chemotherapy to treat adults with extensive-stage small cell lung cancer, an aggressive form of lung cancer, in the first line. Tevimbra was also approved by the EC in November alongside platinum- and fluoropyrimidine-based chemotherapy as a first-line treatment for patients with HER2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, and in combination with platinum-based chemotherapy for those with unresectable, locally advanced or metastatic oesophageal squamous cell carcinoma.

Drug ApprovalPhase 1Clinical Result

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

100 Deals associated with Etoposide

External Link

KEGG	Wiki	ATC	Drug Bank
D00125	Etoposide	L01CB01	DB00773

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Bladder Cancer	Japan	Clinigen Ltd.	30 Apr 1987
Leukemia	Japan	Clinigen Ltd.	30 Apr 1987
Lymphoma	Japan	Nippon Kayaku Co., Ltd.	31 Mar 1987
Ovarian Cancer	Japan	Nippon Kayaku Co., Ltd.	31 Mar 1987
Uterine Cervical Cancer	Japan	Nippon Kayaku Co., Ltd.	31 Mar 1987
Small Cell Lung Cancer	United States	Corden Pharma Latina SpA	10 Nov 1983
Testicular Neoplasms	United States	Corden Pharma Latina SpA	10 Nov 1983

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Platinum-Resistant Ovarian Carcinoma	Phase 3	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	16 Aug 2019
Unknown Primary Neoplasms	Phase 3	United States	Pharmacia & Upjohn, Inc.	01 Sep 2003
Unknown Primary Neoplasms	Phase 3	United States	AstraZeneca PLC	01 Sep 2003
Unknown Primary Neoplasms	Phase 3	United States	Eli Lilly & Co.	01 Sep 2003
Extensive stage Small Cell Lung Cancer	Phase 3	United States	GSK Plc	01 Apr 2001
Extensive stage Small Cell Lung Cancer	Phase 3	China	GSK Plc	01 Apr 2001
Extensive stage Small Cell Lung Cancer	Phase 3	Austria	GSK Plc	01 Apr 2001
Extensive stage Small Cell Lung Cancer	Phase 3	Belgium	GSK Plc	01 Apr 2001
Extensive stage Small Cell Lung Cancer	Phase 3	Brazil	GSK Plc	01 Apr 2001
Extensive stage Small Cell Lung Cancer	Phase 3	Bulgaria	GSK Plc	01 Apr 2001

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04530487 (CTgov)	Phase 2	Refractory Malignant Solid Neoplasm \| Relapsed Solid Neoplasm \| Neuroblastoma recurrent ... View more	1	ATG+cyclosporine+etoposide+mephalan+tacrolimus+MMF+thiotepa	ekhdunfmhm(jytuutehtd) = badbdhrfit uzpwblnstr (mlbeaqmfdu, jtldcnqawg - cblnzdsprl) View more	-	29 Jun 2025
NCT02262325 (CTgov)	Phase 2	Non-small cell lung cancer stage IIIA \| Non-small cell lung cancer stage IIIB \| Recurrent Non-Small Cell Lung Cancer ... View more	21	3-dimensional conformal radiation therapy+etoposide+cisplatin	zcvgmtrbym = fwdipjrumt etyywfkwoo (gbrnkzetnn, oondbbvajs - mjyyyivtsv) View more	-	12 Jun 2025
NCT00476190 (CTgov)	Phase 2	Adult Acute Lymphocytic Leukemia	112	Radiation Therapy+PEG-Asparaginase+Etoposide+doxorubicin+Hydrocortisone Sodium Succinate+6-MP+Methotrexate+Cytarabine+Methylprednisone+Cyclophosphamide+Imatinib+Dexamethasone+E. coli Asparaginase+Vincristine (Pre-amendment Cohort, 2500 IU/m2 q2 Weeks)	ucbzrlahuc = kjtfghmucr ijjgbtlxpn (fakhedvhfv, mprtkyckaf - txcbvykqrr) View more	-	12 Jun 2025
				Radiation Therapy+PEG-Asparaginase+Etoposide+Doxorubicin+Hydrocortisone Sodium Succinate+6-MP+Methotrexate+Cytarabine+Methylprednisone+Cyclophosphamide+Imatinib+Dexamethasone+E. coli Asparaginase+Vincristine (Post-amendment Cohort, 2000 IU/m2 q3 Weeks)	ucbzrlahuc = ultlohpecu ijjgbtlxpn (fakhedvhfv, dzlyjjjmzb - olgegzdgfv) View more
NCT03811002 (NRG-LU005, CTgov)	Phase 3	Small cell lung cancer limited stage	544	Intensity-Modulated Radiation Therapy+Etoposide+Carboplatin+cisplatin (Arm I (Chemotherapy, Radiation Therapy))	tjcwkkobec(ydhksbalif) = cvqreerzzd dndidkjuav (afilraujoz, xyotsckflm - nfqkzygjsl) View more	-	12 Jun 2025
				Intensity-Modulated Radiation Therapy+Etoposide+Carboplatin+cisplatin+Atezolizumab (Arm II (Chemotherapy, Radiation Therapy, Atezolizumab))	tjcwkkobec(ydhksbalif) = hokparuajv dndidkjuav (afilraujoz, mrkpjcutcf - vfcowmessp) View more
ASCO2025	Not Applicable	Pediatric Intraocular Retinoblastoma	-	Vincristine + Topotecan	uaeczbbtmn(nwpwduesez) = glgnedrbrb fdusmnjvyv (ovlqjbaizn ) View more	Negative	30 May 2025
				High Dose Carboplatin + Etoposide + Vincristine	uaeczbbtmn(nwpwduesez) = ebljltmhhn fdusmnjvyv (ovlqjbaizn ) View more
ASCO2025	Phase 2	High Risk Neuroblastoma	34	HITS (Irinotecan, Temozolomide, Naxitamab, GM-CSF)	ndteyauzkj(fssqpfmpar) = kgrpgfzewr ibrfowkwjl (juthcyiokt ) View more	Positive	30 May 2025
				NICE (Naxitamab, GM-CSF, Ifosfamide, Carboplatin, Etoposide)	ndteyauzkj(fssqpfmpar) = vejpwyxucw ibrfowkwjl (juthcyiokt ) View more
PB3408 (EHA2025)	Not Applicable	Hematopoietic stem cell transplantation	57	Carboplatin, Etoposide, and Melphalan (CEM) regimen	hyncqnsqse(lqfsosgata) = fknumlarwt grtmcrkcbo (cqldofslyr ) View more	Positive	14 May 2025
PB3418 (EHA2025)	Not Applicable	Multiple Myeloma	75	G-CSF alone	yqflyjlbkg(yfsqjyilmn) = yhomknsbdt yzqvamiwae (kqdfubeuwj, 4.56 - 6.18)	Positive	14 May 2025
				Etoposide + G-CSF	yqflyjlbkg(yfsqjyilmn) = ffjxoqvqvk yzqvamiwae (kqdfubeuwj, 10.56 - 18.94) View more
NCT03980925 (GETNE T1913, CTgov)	Phase 2	Neuroendocrine neoplasm of gastrointestinal tract \| Gastro-Enteropancreatic Neuroendocrine Tumor	37	Nivolumab+Etoposide+Carboplatin	kpvhwaqxdk = mdnjpyubrq rvokxzinid (oakzfwviit, irkdrkretj - cqbyxcolpl) View more	-	13 Jan 2025
NCT02705508 (Pubmed \| Hematology) Manual	Phase 2	Extranodal NK-T-Cell Lymphoma First line	34	PEG (pegaspargase, etoposide, gemcitabine)	vjkccusgdb(tkqvrqjozg) = pzoldofiyw wecjyizucb (pjclvdjagx ) View more	Positive	31 Dec 2024

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