This phase II trial tests how well the combination of epcoritamab and lenalidomide work in treating patients with immunodeficiency-related large B-cell lymphoma that does not respond to treatment (refractory) or that has come back after a period of improvement (relapsed). Epcoritamab is an immunotherapy that engages T-cells in the immune system to help redirect their killing effects against lymphoma cells. Lenalidomide can modulate the immune system to enhance killing effects of lymphoma by the immune system as well. Giving patients a combination of epcoritamab and lenalidomide may work better in treating refractory or relapsed immunodeficiency-related large B-cell lymphoma.

Start Date18 Feb 2025

Sponsor / Collaborator

Northwestern University

[+1]

KCT0009989 / Not yet recruitingPhase 2IIT

Phase II study of minimal residual disease guided step-up approach of Teclistamab and daratumumab with or without lenalidomide for Newly Diagnosed Multiple Myeloma who are ineligible for ASCT

Start Date03 Feb 2025

Sponsor / Collaborator

Asan Medical Center

NCT06649812 / Not yet recruitingPhase 2IIT

A Phase 2 Study of Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed or Refractory CD10-Negative Diffuse-Large B-Cell Lymphoma (DLBCL) and High-Grade B-Cell Lymphoma With MYC and BCL2 Rearrangements (HGBCL-DH-BCL2)

This phase II trial tests how well venetoclax, ibrutinib, prednisone, obinutuzumab, and Revlimid® (ViPOR) works in treating patients with CD10 negative diffuse large B-cell lymphoma (DLBCL) and high-grade lymphoma with MYC and BCL2 rearrangements that has come back after a period of improvement (relapsed) and/or that has not responded to previous treatment (refractory). Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Ibrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cell (a type of white blood cells) cancers at abnormal levels. This may help keep cancer cells from growing and spreading. Anti-inflammatory drugs, such as prednisone lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Obinutuzumab, a monoclonal antibody, binds to a protein called CD20, which is found on B cells and some types of leukemia and lymphoma cells. Obinutuzumab may block CD20 and help the immune system kill cancer cells. Revlimid, a type of anti-angiogenesis agent and a type of immunomodulating agent, may help the immune system kill abnormal blood cells or cancer cells. It may also prevent the growth of new blood vessels that cancers need to grow. ViPOR may be an effective treatment option for patients with relapsed and/or refractory CD10 negative DLBCL and high-grade B-cell lymphoma with MYC and BCL2 rearrangements.

Start Date17 Jan 2025

Sponsor / Collaborator

National Cancer Institute

100 Clinical Results associated with Lenalidomide

100 Translational Medicine associated with Lenalidomide

100 Patents (Medical) associated with Lenalidomide

6,115

Literatures (Medical) associated with Lenalidomide

01 Jan 2025·JOURNAL OF MOLECULAR MODELING

Intercalation of the anticancer drug lenalidomide into montmorillonite for bioavailability improvement: a computational study

Article

Author: Meruvia-Rojas, Yumeida V ; Molina-Montes, Esther ; Hernández-Laguna, Alfonso ; Sainz-Díaz, C Ignacio

Abstract:

Context:

Lenalidomide (LEN) is used for the treatment of myeloma blood cancer disease. It has become one of the most efficient drugs to halt this disease. LEN is a low-soluble drug in aqueous media. The search of a pharmaceutical preparation to improve the bioavailability and, therefore, to optimize its efficiency is an important issue for pharmaceutical industries and health care. The use of natural excipients such as montmorillonite (MNT) can provide changes in the physical–chemical properties for improving the bioavailability of this drug. We present the first computational study at the atomic scale of the periodic crystal forms of the polymorphs for this anticancer drug, highly demanded in the pharmacy market. In addition, we propose a pharmaceutical preparation by intercalation of LEN in natural MNT. So, our calculations predict that LEN can be intercalated in the interlayer space of MNT, and be released in aqueous media, and physiological aqueous media in consequence. This release process is a more exothermic reaction than the unpacking energy of any of its polymorphs. Besides, the infrared spectra of the LEN molecule and its crystal polymorphs, and LEN intercalated in the confined space of MNT, have been calculated at different levels of theory. The band frequencies have been assigned, matching with the experimental bands, predicting the use of this technique for experimental studies.

Method:

In this work, the method is aimed to explore this research at the atomic and molecular level by using computational modelling methods including INTERFACE FF and other FF along with quantum mechanical calculations (Dmol3 and CASTEP) of 3-D periodical systems applying periodical boundary conditions. Models of the isolated molecule and two polymorphs of the crystal structures, with the model of bulk water and LEN intercalated in the MNT model, have been considered. An analysis of the intermolecular interactions is accomplished.

01 Jan 2025·EUROPEAN JOURNAL OF HAEMATOLOGY

Real‐World Evidence on Prognostic Value of MRD in Multiple Myeloma Using Flow Cytometry

Article

Author: Stork, Martin ; Straub, Jan ; Novak, Martin ; Jelinek, Tomas ; Bezdekova, Renata ; Pour, Ludek ; Plonkova, Hana ; Soucek, Ondrej ; Hajek, Roman ; Maisnar, Vladimir ; Minarik, Jiri ; Rihova, Lucie ; Zihala, David ; Látal, Vojtech ; Sevcikova, Tereza ; Spacek, Martin ; Jungova, Alexandra ; Venglar, Ondrej ; Rezacova, Vladimira ; Popkova, Tereza ; Muronova, Ludmila ; Dekojova, Tereza ; Radocha, Jakub

ABSTRACT:

Minimal residual disease (MRD) is one of the most important prognostic factors in multiple myeloma (MM) and a valid surrogate for progression‐free survival (PFS) and overall survival (OS). Recently, MRD negativity was approved as an early clinical endpoint for accelerated drug approval in MM. Nevertheless, there is limited evidence of MRD utility in real‐world setting. In this retrospective multicenter study, we report outcomes of 331 newly diagnosed MM patients with MRD evaluation at Day+100 after autologous stem cell transplantation using flow cytometry with a median limit of detection of 0.001%. MRD negativity was reached in 47% of patients and was associated with significantly prolonged median PFS (49.2 months vs. 18.4 months; hazard ratios (HR) = 0.37; p < 0.001) and OS (not reached vs. 74.9 months; HR = 0.50; p = 0.007). Achieving MRD negativity was associated with PFS improvements regardless of age, International Staging System (ISS) stage, lactate dedydrogenase (LDH) level, or cytogenetic risk. Importantly, MRD positive patients benefited from lenalidomide maintenance versus no maintenance (18‐months PFS: 81% vs. 46%; HR = 0.24; p = 0.002) while in MRD negative patients such benefit was not observed (p = 0.747). The outcomes of our real‐world study recapitulate results from clinical trials including meta‐analyses and support the idea that MRD positive patients profit more from lenalidomide maintenance than MRD negative ones.

01 Jan 2025·EUROPEAN JOURNAL OF CANCER

Characteristics and outcomes in patients with lenalidomide-refractory multiple myeloma treated with 1-3 prior lines of therapy: Analysis of individual patient-level data from daratumumab clinical trials

Article

Author: Yong, Kwee ; Einsele, Hermann ; Roccia, Tito ; Connors, Kaitlyn ; Carson, Robin ; Kharat, Akshay ; Lendvai, Nikoletta ; Valluri, Satish ; Pacaud, Lida ; Slaughter, Ana ; Dhakal, Binod ; Qi, Keqin ; Cost, Patricia ; Mendes, João ; Londhe, Anil ; Florendo, Erika ; Lonardi, Carolina ; Deraedt, William ; Schecter, Jordan M ; Patel, Nitin

BACKGROUND:

The introduction of proteasome inhibitors (PIs) and lenalidomide as treatment for newly diagnosed multiple myeloma (MM) has led to an increased population of lenalidomide-refractory patients. Limited data are available characterizing current treatments and outcomes in this difficult-to-treat population.

METHODS:

Individual patient-level data were analyzed from the treatment arms of multiple daratumumab studies, including APOLLO, CASTOR, CANDOR, EQUULEUS, ALCYONE, MAIA, GRIFFIN, POLLUX, and CASSIOPEIA. Included patients were PI exposed and lenalidomide refractory, received 1-3 prior lines of therapy (LOT), and had an Eastern Cooperative Oncology Group performance status < 2. Treatments and outcomes were analyzed by number of prior LOT in the lenalidomide-refractory population. Time to next treatment (TTNT), progression-free survival (PFS), and overall survival (OS) were estimated using the Kaplan-Meier method.

FINDINGS:

Out of 4764 patients, 915 patients (prior LOT, one [n = 114]; two [n = 462]; three [n = 339]) met inclusion criteria. Median follow-up was 29·7 months (range 28·0-31·7). The overall response rate was 55·4 %. Estimated median TTNT was 9·7 months, median PFS was 10·0 months, and median OS was 27·5 months. Response rates and PFS decreased as number of prior LOT increased. Prognostic factors for response, TTNT, PFS, and OS included International Staging System stage, baseline plasmacytoma status, baseline hemoglobin, anti-CD38-refractory status, and cytogenetic risk status.

INTERPRETATION:

Lenalidomide-refractory patients treated with 1-3 prior LOT have poor PFS and OS, which generally worsen with each additional LOT, highlighting the need for new and effective treatments for this population.

633

News (Medical) associated with Lenalidomide

13 Dec 2024

·www.globenewswire.com

CARVYKTI® Significantly Improved Minimal Residual Disease Negativity Compared to Standard of Care for Patients with Relapsed or Refractory Multiple Myeloma

89 percent of evaluable patients achieved minimal residual disease (MRD) negativity with CARVYKTI® after three-year follow-up in CARTITUDE-4 study; the majority in less than 2 months Results add to the overall survival (OS) benefit recently reported making CARVYKTI® the first and only cell therapy to significantly extend OS versus standard therapies in multiple myeloma Landmark Phase 3 CARTITUDE-4 study data featured as an oral presentation at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition Dec. 09, 2024 -- Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, announced today new results from the Phase 3 CARTITUDE-4 study that show a single infusion of CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) provided significantly higher rates of minimal residual disease (MRD)-negativity in patients with relapsed or lenalidomide-refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD, compared to standard therapies of pomalidomide, bortezomib, and dexamethasone (PVd) or daratumumab, pomalidomide, and dexamethasone (DPd).1 MRD negativity is a prognostic marker of prolonged survival outcomes for patients with multiple myeloma.1 These results reinforce the clinical value of CARVYKTI® as early as second line and support the recent achievement of overall survival (OS) benefit versus standard therapies1. The MRD negativity findings were featured as an oral presentation at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition (Abstract #1032) in San Diego, California.1 “The MRD data further underscores the benefits of treatment with CARVYKTI,” said Yi Lin, M.D., Ph.D., hematologist and oncologist at Mayo Clinic, Rochester, MN. “These new findings support CARVYKTI as a transformative therapeutic option, leading to improved progression-free survival, overall survival, and now minimal residual disease negativity.” ‡ The Phase 3 CARTITUDE-4 study evaluated CARVYKTI® in comparison to standard therapies of PVd or DPd for the treatment of adults with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy, including a PI and IMiD, and who were lenalidomide-refractory. In the trial, 208 adults were randomized to receive CARVYKTI®, and 211 to receive standard therapies. The study assessed patients for MRD negativity at the 10-5 threshold (cilta-cel, n=145, standard therapies, n=103). At a median follow-up of almost three years (34 months), evaluable patients treated with CARVYKTI® achieved an MRD-negativity rate of 89% versus 38% for those treated with standard therapies (P® with 69% of MRD-evaluable patients by day 56. At data cutoff, sustained MRD-negative ≥CR of at least 12 months was achieved in 52% of MRD-evaluable patients in the CARVYKTI® arm vs. 10% in the standard of care arm (P® was administered earlier in the treatment regimen. “The latest MRD data showcases the advances of CARVYKTI and further demonstrates why it is a leading treatment for patients with multiple myeloma,” said Ying Huang, Ph. D., Chief Executive Officer of Legend Biotech. “As we strive to transform the therapeutic landscape in cancer and beyond, we are proud of the progress made and will continue our efforts to improve the quality of life for those battling incurable diseases.” Data from CARTITUDE-4 supported the U.S. Food and Drug Administration (FDA) and European Commission (EC) approval of CARVYKTI® earlier this year for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a PI, and IMiD, and are refractory to lenalidomide.1 CARVYKTI® is the first and only BCMA-targeted CAR-T cell therapy approved for the treatment of patients with multiple myeloma who have had at least one prior line of therapy. Globally, CARVYKTI® is now commercially available in five countries and has been utilized by over 4,500 patients. Ciltacabtagene autoleucel is a BCMA-directed, genetically modified autologous T-cell immunotherapy, which involves reprogramming a patient’s own T-cells with a transgene encoding a chimeric antigen receptor (CAR) that identifies and eliminates cells that express BCMA. The cilta-cel CAR protein features two BCMA-targeting single domain antibodies designed to confer high avidity against human BCMA. Upon binding to BCMA-expressing cells, the CAR promotes T-cell activation, expansion, and elimination of target cells.2 In December 2017, Legend Biotech entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc. (Janssen), a Johnson & Johnson company, to develop and commercialize cilta-cel. In February 2022, cilta-cel was approved by the U.S. Food and Drug Administration (FDA) under the brand name CARVYKTI® for the treatment of adults with relapsed or refractory multiple myeloma. In April 2024, cilta-cel was approved for the second-line treatment of patients with relapsed/refractory myeloma who have received at least one prior line of therapy including a proteasome inhibitor, an immunomodulatory agent, and are refractory to lenalidomide. In May 2022, the European Commission (EC) granted conditional marketing authorization of CARVYKTI® for the treatment of adults with relapsed or refractory multiple myeloma. In September 2022, Japan’s Ministry of Health, Labour and Welfare (MHLW) approved CARVYKTI®. Cilta-cel was granted Breakthrough Therapy Designation in the U.S. in December 2019 and in China in August 2020. In addition, cilta-cel received a PRIority MEdicines (PRIME) designation from the European Commission in April 2019. Cilta-cel also received Orphan Drug Designation from the U.S. FDA in February 2019, from the European Commission in February 2020, and from the Pharmaceuticals and Medicinal Devices Agency (PMDA) in Japan in June 2020. In March 2022, the European Medicines Agency’s Committee for Orphan Medicinal Products recommended by consensus that the orphan designation for cilta-cel be maintained on the basis of clinical data demonstrating improved and sustained complete response rates following treatment. CARTITUDE-4 (NCT04181827) is an ongoing, international, randomized, open-label Phase 3 study evaluating the efficacy and safety of cilta-cel versus pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd) in adult patients with relapsed or lenalidomide-refractory multiple myeloma who received one to three prior lines of therapy, including a PI and an IMiD.3 Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excessive proliferation of plasma cells.4 In 2024, it is estimated that more than 35,000 people will be diagnosed with multiple myeloma, and more than 12,000 people will die from the disease in the U.S.5 While some patients with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections.6 Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogeneic chimeric antigen receptor T-cell, gamma-delta T cell (gd T) and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of cutting-edge therapeutics for patients worldwide. REFERENCES ____________________________________ 1 Rakesh Popat et al. Ciltacabtagene Autoleucel (Cilta-cel) Vs Standard of Care (SoC) in Patients with Lenalidomide (Len)-Refractory Multiple Myeloma (MM) after 1-3 Lines of Therapy: Minimal Residual Disease (MRD) Negativity in the Phase 3 Cartitude-4 Trial. American Society of Hematology 2024 Annual Meeting. December 2024 2 CARVYKTI™ Prescribing Information. Horsham, PA: Janssen Biotech, Inc. 3 ClinicalTrials.Gov. A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma (CARTITUDE-4). https://www.clinicaltrials.gov/study/NCT04181827. Accessed March 2024. 4 American Cancer Society. ”What is Multiple Myeloma?”. Available at: https://www.cancer.org/cancer/types/multiple-myeloma/about/what-is-multiple-myeloma.html. Accessed March 2024. 5 American Cancer Society. “Key Statistics About Multiple Myeloma.” Available at: https://www.cancer.org/cancer/types/multiple-myeloma/about/key-statistics.html. Accessed March 2024 6 American Cancer Society. Multiple myeloma: early detection, diagnosis, and staging. Available at: https://www.cancer.org/content/dam/CRC/PDF/Public/8740.00.pdf. Accessed March 2023. 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$CARVYKTI® Significantly Improved Minimal Residual Disease Negativity Compared to Standard of Care for Patients with Relapsed or Refractory Multiple Myeloma$

Clinical ResultDrug ApprovalASHCell Therapy

12 Dec 2024

·www.globenewswire.com

Invea Therapeutics Strengthens Leadership with Appointment of Dr. Stephen Doberstein, Veteran Biotech Executive, to Its Board of Directors

Dr. Doberstein brings extensive biotech leadership experience as the company advances its AI-powered pipeline into Phase 2 for immune-mediated inflammatory disordersGUILFORD, Conn., Dec. 12, 2024 (GLOBE NEWSWIRE) -- Invea Therapeutics, Inc. (Invea), a leading biotechnology company developing an artificial intelligence (AI), GenAI, and machine learning (ML) powered pipeline of transformational medicines for highly debilitating immune-mediated inflammatory diseases (IMIDs), today announced the appointment of Stephen Doberstein, Ph.D. to its Board of Directors. Dr. Doberstein is a highly regarded biotech executive with over 30 years of experience in drug discovery, development, and corporate financial strategy. “We are excited to welcome Dr. Doberstein to our board. His exceptional leadership in advancing drug development programs will be instrumental as we continue to progress our AI-driven pipeline into mid-stage clinical execution,” said Krishnan Nandabalan, Ph.D., Chairman, President, and CEO at Invea Therapeutics. “Dr. Doberstein’s expertise aligns perfectly with our commitment to developing transformative therapies for IMIDs, and we look forward to benefiting from his guidance in both financing strategy and drug development expertise,” he added. Dr. Doberstein has held numerous senior leadership positions in the biopharma industry, has led multiple drug programs through clinical trials, and has broad expertise in therapeutic areas such as oncology, immunology, and inflammation. His experience in both early-stage and late-stage development, and corporate financing will bring significant value as Invea prepares to advance its pipeline into Phase 2 clinical development. “I am excited to join Invea Therapeutics at a pivotal moment in its growth,” said Dr. Stephen Doberstein. “Invea’s disruptive R&D platform, leverages cutting-edge GenAI and machine learning algorithms to accelerate the speed and scale at which new treatments can be brought to market and enhances the probability of clinical success. I am particularly enthusiastic about Invea's commitment to addressing the significant unmet need for oral therapies in this space, offering a more accessible, cost-effective alternative to a market dominated by expensive injectable biologics. By providing safe, long-term oral treatments, Invea hopes to improve compliance, reduce healthcare burdens, and drive better outcomes,” he added. Dr. Doberstein joins a distinguished group of board members with deep expertise in biotechnology, AI-driven drug discovery, and clinical development, further strengthening Invea’s leadership as it progresses toward mid-stage clinical execution. About Dr. Stephen DobersteinDr. Doberstein is a seasoned biopharma leader with over 30 years of experience in innovative research and development strategies. After earning a Ph.D. in Cell Biology from Johns Hopkins University School of Medicine and completing postdoctoral training at UC Berkeley, he played key roles at multiple biotech companies. He held senior positions such as Director of Cell Biology at Exelixis and Vice President of Research at Xencor, FivePrime Therapeutics, and Xoma. Most recently, he served as Chief R&D Officer at Nektar Therapeutics. Dr. Doberstein’s expertise encompasses the discovery and development of biologics and small molecule therapies, with a proven track record of advancing therapeutic innovation. He has served on the Board of Directors for Dicerna Pharmaceuticals (prior to its acquisition by Novo Nordisk), Forte Biosciences (FBRX), and Parmedics Inc., and is a member of the Biotechnology Advisory Board at the University of Delaware. About Invea TherapeuticsInvea Therapeutics is a clinical-stage biotechnology company focused on developing safe and effective oral small molecule therapeutics for immune-mediated inflammatory diseases (IMIDs). Our mission is to control inflammation, prevent tissue damage, improve quality of life, and achieve long-term disease remission. At the core of our innovative approach is the integration of artificial intelligence (AI), generative AI, and machine learning (ML), enabling our expert team to uncover the mechanisms driving inflammation across a range of IMIDs. We are advancing a robust pipeline of product candidates: INVA8001: A highly selective and potent oral chymase inhibitor targeting the clinically validated stem cell factor (SCF)-c-KIT axis, which plays a key role in mast cell-driven inflammation. INVA8001 is initially poised to enter Phase 2b clinical development for chronic urticaria with the potential to impact several other mast cell disorders.INVA8003: A preclinical novel, oral small molecule multi-inflammasome inhibitor that has shown strong inhibition of key pro-inflammatory markers in early preclinical studies. For more information, contact:Invea TherapeuticsAnita Ganjoo, Ph.D.Corporate Communicationsaganjoo@inveatx.com

Executive ChangePhase 2Acquisition

10 Dec 2024

·www.globenewswire.com

Enterome’s Immunotherapy EO2463 Shows Early Clinical Response in Newly Diagnosed Follicular Lymphoma Suggesting a Potential Alternative to 'Watchful Waiting'

46% objective response rate, with 15% complete responses and 31% partial responses in patients with early-stage follicular lymphoma reported at the ASH 2024 meeting.Well-tolerated treatment with no severe adverse events.Early CD8+ T cell expansion may predict positive clinical outcomes.Findings support EO2463 as a proactive treatment option for asymptomatic patients who typically go untreated. Paris, France – December 10, 2024 Enterome, a clinical-stage company developing first-in-class immunomodulatory drugs for cancer based on its unique Mimicry platform, today announced new clinical data from the ongoing Phase 1/2 ‘SIDNEY’ trial evaluating EO2463 in patients with indolent Non Hodgkin Lymphoma. The data were presented in two posters at the 66th American Society of Hematology (ASH) Annual Meeting and Conference by Dr. Villasboas Bisneto, M.D., hematologist and oncologist at Mayo Clinic, and Dr. Stephen Smith, M.D., hematologist and oncologist at Fred Hutchinson Cancer Center. Enterome is also holding a webinar on December 12, 2024 for external audiences in order to run through the data sets. See details at the end of this release. The Phase 1/2 SIDNEY trial (EONHL1-20) investigates EO2463, an off-the-shelf immunotherapy targeting four B cell antigens and based on Enterome’s OncoMimic™ peptides, in patients with frequent forms of indolent Non-Hodgkin Lymphoma. In Cohort 2 of the SIDNEY trial, patients with newly diagnosed, asymptomatic follicular lymphoma, received EO2463 monotherapy as an alternative to the standard “watch-and-wait” approach. With most patients still on study treatment, an objective response rate of 46% has been observed in the first 13 patients, including 15% complete responses and 31% partial responses. Consistent with observations from the safety lead-in cohort, the treatment was well tolerated, with no severe adverse events, suggesting EO2463 may offer a safe treatment option for patients with early-stage disease. A biomarker analysis was conducted in Cohort 1 (EO2463 in monotherapy and in combination with lenalidomide/rituximab, in patients with relapsed/refractory disease) to explore whether early CD8+ T cell expansion in response to EO2463 administration could serve as a predictor of later clinical benefit. The current assessment indicates that the biomarker as applied (measuring fast expansion of EO2463 specific CD8 T cells) can predict for clinical response, both for EO2463 monotherapy, and for EO2463 in combination with lenalidomide + rituximab. Jan Fagerberg, Chief Medical Officer of Enterome, commented, “These new data provide encouraging indications that EO2463 can safely induce meaningful responses in patients with newly diagnosed follicular lymphoma typically managed with observation alone, addressing an important unmet need. Additionally, our biomarker findings open up possibilities for precision immunotherapy by identifying patients most likely to benefit early in their treatment course.” Pierre Bélichard, CEO of Enterome, added, “These promising results from Cohort 2 in the SIDNEY trial mark an important step in our commitment to providing early therapeutic options for patients who would usually not receive immediate treatment due to the absence of safe and effective therapies. We look forward to advancing EO2463 through the SIDNEY trial and to expanding our work with OncoMimics™ immunotherapies in other blood cancer types.” Details of the poster presentations: Abstract #1616 Title: EO2463 Peptide Immunotherapy in Patients with Indolent NHL: A Phase 1 Exploration of a Response Biomarker for EO2463 Monotherapy and EO2463 in Combination with Lenalidomide/RituximabPresenting Author: Jose Caetano (JC) Villasboas, MD Mayo ClinicSession: 622. Lymphomas: Translational – Non-Genetic: Poster I Abstract #4395 Title: EO2463 Peptide Immunotherapy in Patients with Newly Diagnosed Asymptomatic Follicular Lymphoma Results in Monotherapy Objective Clinical Responses Linked with Anti-Peptide Specific CD8 Memory T Cell Responses: The EONHL1-20/SIDNEY StudyPresenting Author: Dr. Stephen Smith, M.D., UW Medicine, Fred Hutchinson Cancer Research CenterSession: 623. Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster III About EONHL1-20/SIDNEY: SIDNEY (EONHL1-20) is a Phase 1/2 multicenter, open-label, first-in-human study of EO2463 as a monotherapy and in combination with lenalidomide and/or rituximab for the treatment of patients with iNHL. The study aims to assess the safety, tolerability, immunogenicity, and preliminary efficacy of EO2463 monotherapy and combination therapy in approximately 60 patients with follicular lymphoma (FL) and marginal zone lymphoma (MZL). For more information on the study, visit www.Clinicaltrials.gov, reference: NCT04669171. About EO2463: EO2463 is an innovative, off-the-shelf immunotherapy candidate that combines four synthetic OncoMimic™ peptides. These non-self, microbial-derived peptides correspond to CD8 HLA-A2 epitopes that exhibit molecular mimicry with the B lymphocyte-specific lineage markers CD20, CD22, CD37, and CD268 (BAFF receptor). EO2463 also includes the helper peptide (CD4+ epitope) universal cancer peptide 2 (UCP2). The unique ability of EO2463 immunotherapy to selectively target multiple B cell markers enables the destruction of malignant B lymphocytes that are abundant in iNHL. By ensuring broad target coverage across malignant B cells, this novel approach aims to simultaneously improve safety and maximize efficacy, reducing the tumor cells’ capacity to develop immune-resistance mechanisms. Details of the webinar, please register at enterome@vigoconsulting.com to attend. Date: 12 December 2024 Time: 7.30am-8.30am PT / 9.30am-10.30am Central US time / 3.30pm-4.30pm UK / 4.30pm-5.30pm CET Presenters: Jose Caetano (JC) Villasboas, MD Mayo Clinic Pierre Belichard PhD, CEO, Enterome Laurent Chene PhD, Head of Drug Discovery, Enterome Jan Fagerberg, MD, PhD, CMO Enterome Registration link: HERE (https://storm-virtual-uk.zoom.us/webinar/register/WN_jTBLmm7ZRBK6KLvtG3I6Lw) Webinar ID 822 5290 4200 Contacts ENTEROMEMEDIA RELATIONSMarie-Laure BouttierChief Corporate Officer+33 (0)1 75 77 27 85communication@enterome.comVigo ConsultingMelanie Toyne-Sewell / Rozi Morris+44 207 390 0237 / 0231enterome@vigoconsulting.com About Enterome Enterome is a clinical-stage biopharmaceutical company developing breakthrough immunomodulatory drugs for the treatment of cancer. Enterome’s pioneering approach to drug discovery is based on its unique and powerful bacterial Mimicry drug discovery platform, which allows it to analyze and uncover new biological insights from the millions of gut bacterial proteins in constant cross-talk with the human body. Enterome’s first-in-class drug candidates are based on synthetically produced, commensal-derived peptides that modulate the immune system by closely mimicking the structure of specific antigens. The company’s oncology pipeline includes the following OncoMimics™ peptide-based immunotherapies: EO2463, currently in the Phase 2 ‘SIDNEY’ clinical trial for indolent non-Hodgkin lymphomas, has shown a favorable safety profile with promising early signs of efficacy;EO2401, administered in combination with nivolumab and bevacizumab, has demonstrated clinical activity in approximately one-third of patients with recurring glioblastoma in the completed Phase 1/2 ‘ROSALIE’ study;EO4010 is being evaluated in metastatic colorectal cancer in the Phase 1/2 ‘AUDREY’ study. Enterome is headquartered in Paris, France. Since its inception, the company has raised a total of €118 million from Europe- and US-based life science investors, and more than €100 million through pharmaceutical partnerships. For more information, please visit the company’s website at: www.enterome.com

ImmunotherapyClinical ResultPhase 1

100 Deals associated with Lenalidomide

External Link

KEGG	Wiki	ATC	Drug Bank
D04687	Lenalidomide	L04AX04	DB00480

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Marginal Zone B-Cell Lymphoma	US	Bristol Myers Squibb Co.	28 May 2019
Adult T-Cell Leukemia-Lymphoma	JP	Bristol-Myers Squibb KK	02 Mar 2017
Chromosome 5q Deletion Syndrome	EU	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Chromosome 5q Deletion Syndrome	IS	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Chromosome 5q Deletion Syndrome	LI	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Chromosome 5q Deletion Syndrome	NO	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Follicular Lymphoma	EU	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Follicular Lymphoma	IS	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Follicular Lymphoma	LI	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Follicular Lymphoma	NO	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Mantle-Cell Lymphoma	EU	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Mantle-Cell Lymphoma	IS	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Mantle-Cell Lymphoma	LI	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Mantle-Cell Lymphoma	NO	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Transfusion dependent anaemia	EU	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Transfusion dependent anaemia	IS	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Transfusion dependent anaemia	LI	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Transfusion dependent anaemia	NO	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Multiple Myeloma	US	Bristol Myers Squibb Co.	29 Jun 2006
Myelodysplastic Syndromes	US	Bristol Myers Squibb Co.	27 Dec 2005

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Plasmacytoma	Phase 3	US	Millennium Pharmaceuticals, Inc.	01 Dec 2015
Plasmacytoma	Phase 3	US	Biologics, Inc.	01 Dec 2015
Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type	Phase 3	US	Celgene Corp.	17 Feb 2015
Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type	Phase 3	CN	Celgene Corp.	17 Feb 2015
Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type	Phase 3	JP	Celgene Corp.	17 Feb 2015
Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type	Phase 3	AU	Celgene Corp.	17 Feb 2015
Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type	Phase 3	BE	Celgene Corp.	17 Feb 2015
Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type	Phase 3	CA	Celgene Corp.	17 Feb 2015
Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type	Phase 3	CZ	Celgene Corp.	17 Feb 2015
Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type	Phase 3	FR	Celgene Corp.	17 Feb 2015

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04680052 (inMIND, ASH2024) Manual	Phase 3	Follicular Lymphoma	548	Tafasitamab + Lenalidomide + Rituximab	anqdpyxuif(pdmvkzngez) = cmimrrdoez pnnqqwtiwb (kgrtgalijs ) View more	Positive	10 Dec 2024
				Placebo + Lenalidomide + Rituximab	anqdpyxuif(pdmvkzngez) = pcffjejybw pnnqqwtiwb (kgrtgalijs ) View more
NCT03319667 (IMROZ, ASH2024) Manual	Phase 3	Multiple Myeloma First line	446	Isatuximab, Bortezomib, Lenalidomide, and Dexamethasone (Isa-VRd)	exswmrhpmq(bfbzffbhnu) = cpbgdanvpq ccutrwmtwb (ypggpekkhp ) View more	Positive	09 Dec 2024
				Bortezomib, Lenalidomide, and Dexamethasone (VRd)	exswmrhpmq(bfbzffbhnu) = fqgmorvskl ccutrwmtwb (ypggpekkhp ) View more
ASH2024 Manual	Phase 1	Diffuse Large B-Cell Lymphoma	22	Polatuzumab Vedotin+Zanubrutinib+Rituximab+Lenalidomide	orjjsvekcx(eccmxpqpkp) = wztpxwpsip vimkojefql (rtmfqrocpk ) View more	Positive	09 Dec 2024
ASH2024 Manual	Not Applicable	Multiple Myeloma First line	193	Ixazomib,LenalidomideeDexamethasonehasone (IRd)	ytbqwvwtur(mjiocvubee) = vqygxewztw aecgstayto (wvtylelbxc, 11.2) View more	Positive	09 Dec 2024
				Bortezomib,LenalidomideeDexamethasonehasone (VRd)	ytbqwvwtur(mjiocvubee) = ncpmdgqnvi aecgstayto (wvtylelbxc, 3.9) View more
ASH2024 Manual	Phase 1/2	Mantle-Cell Lymphoma	36	Venetoclax 2IbrutinibPrednisoneObinutuzumabLenalidomide	fxbhhjrust(virtraqhcn) = thrombocytopenia (14%), neutropenia (13%), and anemia (10%) mknonbhlcq (noyifgvdou ) View more	Positive	09 Dec 2024
				Venetoclax 4IbrutinibPrednisoneObinutuzumabLenalidomide
ASH2024	Not Applicable	Multiple Myeloma	-	Lenalidomide	zycbxizjfi(qxgngnxrnr) = ibtwxioelw eyfconikww (fixsxzgrdk, 1 - 12)	-	09 Dec 2024
NCT03617731 (GMMG-HD7, ASH2024)	Phase 3	Multiple Myeloma CD38	662	Isatuximab, Lenalidomide, Bortezomib, Dexamethasone	kcghnudgmu(eoyqvxwtwa) = xpqcypinjg mbossbpdxe (xzszjhoiyx, 95% CI 0.52 - 0.94) View more	Positive	09 Dec 2024
				Lenalidomide, Bortezomib, Dexamethasone	kcghnudgmu(eoyqvxwtwa) = fhhzxuvzkh mbossbpdxe (xzszjhoiyx, 95% CI 46 - 48) View more
ASH2024	Not Applicable	Recurrent Multiple Myeloma	-	Belantamab mafodotin 1.4 mg/kg	pazmrciuqb(gqhjxejewl) = 89.5% experienced blurred vision lgqxvinukr (qoxxomkgsr ) View more	-	09 Dec 2024
				Belantamab mafodotin 1.9 mg/kg
NCT03011814 (ASH2024) Manual	Phase 2	Cutaneous T-Cell Lymphoma	25	Durvalumab	vhuakoboce(aowapinqvw) = itooqxuzde qmbaeiwoic (ebgpnghpbc ) View more	Positive	08 Dec 2024
				Durvalumab + Lenalidomide	vhuakoboce(aowapinqvw) = oqekfeekpu qmbaeiwoic (ebgpnghpbc ) View more
CMRG-001 (ASH2024)	Not Applicable	Multiple Myeloma	78	CyBorD induction + HD-Mel + single ASCT + lenalidomide maintenance	jvtfrmxppz(fdvnrrcfit) = kyutlnuuik fvfbjhrlzm (mgtwwfryto, 70 - 88) View more	Positive	08 Dec 2024

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