On February 8, 2021 Lion TCR reported abstracts presentation at the European Association for the Study of the Liver (EASL) Digital Liver Cancer Summit 2021 on 05-06 February 2021 for the use of its lead T-cell product, LioCyx-M for the treatment of unresectable Hepatitis B virus (HBV)- related hepatocellular carcinoma (HCC) in a Phase 1 study (NCT03899415), with an oral abstract (O07) selected for Highlights in the Best of Liver Cancer Summit (Press release, Lion TCR, FEB 8, 2021, View Source [SID1234574729]).
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We have previously presented clinical data for this study at the 2020 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, highlighting the use of LioCyx-M as a promising TCR-T immunotherapy for primary HCC. Here, we present an updated clinical data (poster abstract P065), with supporting biomarker analysis data (oral abstract O07).
The median overall survival was 33.57 months with a follow-up period of 47.9 months and an objective response rate of 16.7%. LioCyx-M infusions were well tolerated with no cytokine release syndrome (CRS), neurotoxicity or other systemic immune-related adverse events observed. Two patients had a self-limiting and localized liver inflammation upon infusion of 1x10E05 cells/kg per bodyweight that fully resolved despite the advanced pathological liver condition of the patient.
A total of 3 patients had elevations of serum chemokines and/or activation of the T cell compartment upon receiving the treatment, indicative of treatment induced immunological alterations. These alterations were followed with subsequent tumour destruction (partial response as per modified RECIST) in one patient with a durable tumour response lasting approximately 30 months, or a stable disease in the other 2, implicating the LioCyx-M treatment induced immunological alterations with anti-tumour response.
Overall, the clinical and biomarker data highlight the good safety profile and efficacy of LioCyx-M. Further exploration of efficacy of LioCyx-M treatment for advanced HBV-HCC is warranted in a Phase 2 study. Lion TCR is actively applying for global multi-center Phase II clinical trials, including the US FDA, Singapore HSA and China NMPA.
Details of oral presentation:
Abstract Title Immunological alterations induced by HBV-TCR T cell immunotherapy associates with treatment response of primary HBV related-HCC
Presenter Name Dr Tan Anthony Tanoto
Abstract Number O07 (Click here for oral presentation slides)
Details of poster presentation:
Abstract Title Phase 1 study of autologous hepatitis B virus (HBV)-specific T cell receptor (TCR) T-cells, LioCyx-M in unresectable HBV-related hepatocellular carcinoma (HCC)
Presenter Name Prof Fu-Sheng Wang
Abstract Number P065 (Click here for poster)
The full abstracts are attached in this release and will be published in The Digital Liver Cancer Summit 2021 abstract book on 22 January at 10:00 CET.
Abstract O07 has been chosen to be highlighted in the Best of Liver Cancer Summit.