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Mini Oral session: Haematological malignancies

207MO - Efficacy and safety of IMC-001, anti-PD-L1 antibody, in patients with relapsed or refractory extranodal NK/T cell lymphoma, nasal type (R/R ENKTL)


04 Dec 2022


Mini Oral session: Haematological malignancies


Clinical Research;  Immunotherapy

Tumour Site



Won Seog Kim


Annals of Oncology (2022) 33 (suppl_9): S1515-S1520. 10.1016/annonc/annonc1127


W.S. Kim1, J. Jo2, Y. Koh3, D.H. Yang4, D.H. Yoon5, J.H. Kwon6, G. Lee7, K.H. Yoo8, J. Oh9, J.H. Lee9, H.T. Kim10

Author affiliations

  • 1 Division Of Hematology And Oncology, Department Of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 06351 - Seoul/KR
  • 2 Department Of Hematology And Oncology, Ulsan University Hospital, University of Ulsan College of Medicine, 44033 - Ulsan/KR
  • 3 Cancer Research Institute, Seoul National University College of Medicine, 03080 - Seoul/KR
  • 4 Department Of Hemato-oncology, Chonnam National University Medical School, Chonnam National University Hwasun Hospital, 58128 - Hwasun/KR
  • 5 Department Of Oncology, University of Ulsan College of Medicine, Asan Medical Center (AMC), 05505 - Seoul/KR
  • 6 Department Of Internal Medicine, ChungBuk National University College of Medicine, 28644 - Cheongju/KR
  • 7 Division Of Hematology-oncology, Department Of Internal Medicine, Gyeongsang National University Hospital and Gyeongsang National University School of Medicine, 52727 - Jinju/KR
  • 8 Department Of Oncology, Gachon University Gil Medical Center, Gachon University College of Medicine, 21565 - Incheon/KR
  • 9 Department Of Clinical Strategy And Operation, ImmuneOncia Therapeutics, Inc., 13487 - Seongnam/KR
  • 10 Chief Medical Officer, ImmuneOncia Therapeutics, Inc., 13487 - Seongnam/KR


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Abstract 207MO


ENKTL is a rare EBV associated lymphoma with high immunogenicity, and the prognosis of R/R ENKTL is extremely poor when asparaginase-based therapy fails. There is no standard treatment, and the clinically unmet demand is so high that new effective treatments are urgently needed. Small studies using PD-1/PD-L1 inhibitors for ENKTL treatment showed varying anti-tumor activity. IMC-001 is a fully human IgG1 monoclonal antibody that binds to human PD-L1 to enhance T cell activation and retains Fc effector function to stimulate antibody-dependent cell-mediated cytotoxicity. We present efficacy and safety of the phase 2 study of IMC-001 in patients with R/R ENKTL.


Patients with histologically confirmed ENKTL who failed to at least one prior therapy including asparaginase-based regimen were enrolled. Patients received IMC-001 20 mg/kg intravenously every two weeks for up to 2 years until disease progression or unacceptable toxicity. The primary endpoint is the objective response rate (ORR) determined by centralized independent assessment per the Lugano criteria with LYRIC modification for lymphoma.


Between October 2020 and June 2022, 13 patients were enrolled and currently 8 patients are receiving treatment. The median age was 59 years (range 46-79), 11 (85%) were male. 6 patients (46%) had an ECOG performance status of 1. Median number of prior systemic therapy was 2 (range 1-4). 9 patients (69%) received radiotherapy. Of the 5 efficacy-evaluable patients, 4 patients had a complete response (CR) and an ORR of 80%. All the patients with CR have continued treatment for at least 1 year. Most treatment-emergent AEs (TEAEs) were grade 1-2, and no grade 3 or more TEAE was observed. The most common AE was fatigue. No TEAEs or serious AEs that resulted in the treatment discontinuation or death. Grade 2 infusion-related reactions (IRR), grade 2 uveitis, and grade 2 hypothyroidism suspected to related to IMC-001 were observed in 1 patient each.


PD-L1 blockade with IMC-001 is highly effective in patients with R/R ENKTL failing L-asparaginase regimens. IMC-001 has a good safety profile without long-term toxicity. We will present updated data for efficacy, safety, and biomarker.

Clinical trial identification


Editorial acknowledgement

Legal entity responsible for the study

ImmuneOncia Therapeutics, Inc.


ImmuneOncia Therapeutics, Inc.


W.S. Kim: Financial Interests, Personal, Advisory Board: Immuneoncia Therapeutics. J. Oh, J.H. Lee, H.T. Kim: Financial Interests, Personal, Full or part-time Employment: Immuneoncia Therapeutics. All other authors have declared no conflicts of interest.

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