Abstract 207MO
Background
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.
Methods
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.
Results
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.
Conclusions
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
NCT04414163.
Editorial acknowledgement
Legal entity responsible for the study
ImmuneOncia Therapeutics, Inc.
Funding
ImmuneOncia Therapeutics, Inc.
Disclosure
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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