{ "abstract": "Background\n\nTimdarpacept (IMM01) is a recombinant signal regulatory protein α-IgG1 fusion protein that exerts antitumor activity by blocking the \"don't eat me\" signal while simultaneously activating the \"eat me\" signal, inducing robust antibody-dependent cellular phagocytosis. We report the final phase II results of treatment-naïve higher risk chronic myelomonocytic leukemia (CMML) patients treated with IMM01 in combination with azacitidine.Patients and methods\n\nWe assessed the safety and efficacy of IMM01 in combination with azacitidine (AZA) as first-line therapy for newly diagnosed CMML patients. IMM01 was administered intravenously at 2.0 mg/kg weekly, and AZA was administered subcutaneously at 75 mg/m² on days 1-7 of each 28-day cycle.Results\n\nAs of the data cut-off on May 13, 2025, 24 patients were enrolled. Of 22 efficacy-evaluable patients, the overall response rate (ORR) was 72.7% (16/22; 95% CI 49.8-89.3), including 27.3% complete response (CR), 13.6% marrow CR (mCR) with hematologic improvement (HI), 4.5% HI alone, and 27.3% mCR alone. The median time to response was 1.8 months (range, 0.9-3.6), and the median duration of response was 16.9 months (95% CI 5.1-NE). Median overall survival and progression-free survival were 22.2 months (95% CI 9.0-NE) and 17.8 months (95% CI 5.3-NE), respectively. The most common grade ≥ 3 treatment-related adverse events (≥ 10%) were lymphopenia (66.7%), leukopenia (62.5%), neutropenia (62.5%), thrombocytopenia (58.3%), anemia (33.3%), and pneumonia (16.7%).Conclusion\n\nIMM01 in combination with AZA was generally well tolerated and effective in treatment-naïve higher risk CMML patients. Trial registration ClinicalTrials.gov identifier: NCT05140811.", "abstract_shown": true, "affiliations": [ "The First Affiliated Hospital of Zhejiang University School of Medicine, 58# Chengzhan Road, Hangzhou, Zhejiang, China.", "Shengjing Hospital of Chinese Medical University, Shenyang, China.", "The First Hospital of Jilin University, Changchun, China.", "Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.", "Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China.", "Tianjin People's Hospital, Tianjin, China.", "The First Hospital of Chinese Medical University, Shenyang, China.", "Zhujiang Hospital of Southern Medical University, Guangzhou, China.", "The First Affiliated Hospital of Nanchang University, Nanchang, China.", "The First Affiliated Hospital of Henan University of Science and Technology, Luoyang, China.", "Xuanwu Hospital of Capital Medical University, Beijing, China.", "Fujian Medical University Union Hospital, Fuzhou, China.", "ImmuneOnco Biopharmaceuticals (Shanghai) Inc., Shanghai, China.", "The First Affiliated Hospital of Zhejiang University School of Medicine, 58# Chengzhan Road, Hangzhou, Zhejiang, China. tonghongyan@zju.edu.cn.", "Blood Diseases Hospital, Institute of Hematology, Chinese Academy of Medical Sciences and Peking Union Medical College, #288 Nanjing Road, Tianjin, China. zjxiao@ihcams.cn." ], "article_type": "research article", "arxiv": null, "author_total": 19, "authors": [ { "affs": [ 0 ], "name": "Liya Ma" }, { "affs": [ 1 ], "name": "Wei Yang" }, { "affs": [ 2 ], "name": "Sujun Gao" }, { "affs": [ 3 ], "name": "Junmin Li" }, { "affs": [ 4 ], "name": "Qingsong Yin" }, { "affs": [ 5 ], "name": "Xingli Zhao" }, { "affs": [ 6 ], "name": "Xiaojing Yan" }, { "affs": [ 7 ], "name": "Sanfang Tu" }, { "affs": [ 8 ], "name": "Fei Li" }, { "affs": [ 9 ], "name": "Haiping Yang" }, { "affs": [ 10 ], "name": "Ronghua Hu" }, { "affs": [ 11 ], "name": "Shaoyuan Wang" }, { "affs": [ 12 ], "name": "Zheng Dong" }, { "affs": [ 12 ], "name": "Xiwen Zhao" }, { "affs": [ 12 ], "name": "Guodong Lu" }, { "affs": [ 12 ], "name": "Zhuli Wu" }, { "affs": [ 12 ], "name": "Wenzhi Tian" }, { "affs": [ 13 ], "name": "Hongyan Tong" }, { "affs": [ 14 ], "name": "Zhijian Xiao" } ], "bibtex": "https://research.draconitic.com/paper/56d2rsy4v351c.bib", "cited_by": 0, "doi": "10.1186/s40164-026-00851-8", "fulltext_url": "https://europepmc.org/articles/PMC13718043", "id": "56d2rsy4v351c", "issns": [ "2162-3619" ], "landing_url": "https://europepmc.org/article/MED/42958448", "language": "eng", "licence": "CC-BY-NC-ND", "licence_label": "CC BY-NC-ND", "licence_source": "article", "licence_url": "https://creativecommons.org/licenses/by-nc-nd/4.0/", "metadata_licence": null, "native_subjects": [ [ "heading", "Research" ], [ "openalex", "2720|Acute Myeloid Leukemia Research" ] ], "openalex": "W7224381410", "pdf_url": "https://europepmc.org/articles/PMC13718043?pdf=render", "pmcid": "PMC13718043", "pmid": "42958448", "published": "2026-10-28", "publisher": "BMC", "ris": "https://research.draconitic.com/paper/56d2rsy4v351c.ris", "sources": [ { "first_seen": "2026-11-01T00:20:36Z", "native_id": "MED:42958448", "source": "europepmc", "url": "https://europepmc.org/article/MED/42958448" }, { "first_seen": "2026-11-02T12:22:12Z", "native_id": "PMC13718043", "source": "pmc", "url": "https://doi.org/10.1186/s40164-026-00851-8" } ], "subjects": [ { "field": "medicine", "origin": "openalex:2720|Acute Myeloid Leukemia Research", "subfield": "general" } ], "title": "Timdarpacept (IMM01) combined with azacitidine (AZA) as first-line therapy in adults with higher risk chronic myelomonocytic leukemia (CMML): results from a prospective, multicenter, phase II study.", "title_text": "Timdarpacept (IMM01) combined with azacitidine (AZA) as first-line therapy in adults with higher risk chronic myelomonocytic leukemia (CMML): results from a prospective, multicenter, phase II study.", "type": "peer-reviewed", "updated_at": "2026-11-02T12:22:12Z", "url": "https://research.draconitic.com/paper/56d2rsy4v351c", "venue": "Experimental hematology & oncology", "versions": [] }