Clinical outcomes from a phase I clinical trial of a novel oncolytic virus VG161 in patients with hepatocellular carcinoma (HCC) refractory after 2 prior lines of therapy including checkpoint inhibitors (CPI)
Abstract
4105 Background: This study aims to investigate the safety and anti-tumor activity of VG161 expressing IL12, IL15/IL15 receptor α unit, and PD-L1 blocking peptide in patients with HCC refractory to standard therapies. Methods: The study was conducted as a multicenter phase I trial with fast titration and 3+3 dose escalation part (A) and expansion part (B), which enrolled patients with primary liver cancer refractory to standard therapies. Patients in part A were dosed in 5 cohorts on days 1, 2 and 3 by image-guided intratumoral injections with dosing ranges from 1.0×10^8 to 5×10^8 PFU per 28 days treatment cycles. Part B used a single arm Simon's two-stage design at the recommended phase 2 dose (RP2D). The study endpoints were safety, and efficacy assessed by objective response rate (ORR) and Disease Control Rate (DCR) by RECIST1.1 and mRECIST (HCC), PFS and OS. Pretreatment HCC tumor samples were collected and analyzed by RNAseq. Results: 44 patients including 40 HCC (Male/Female: 37/3; median age: 58years) were dosed and no DLTs were reported. The most common Treatment-Related Adverse Events (TRAEs) was fever, which was resolved with symptomatic treatment. RP2D was determined as 1ⅹ10^8 PFU daily on day 1, 2 and 3 of each cycle. Of 40 HCC patients, 35 failed after 2 prior lines of therapy and were eligible for tumor assessment. ORR was 17.14% (6/35), DCR was 60.00% (21/35). The median PFS and OS were 2.90 (95%CI: 1.85-3.95) and 9.40 (95%CI: 0.47-18.33) months respectively.…
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