54P Oncolytic virus combined PD-1 antibody toripalimab in advanced lung cancer with liver metastases: An early stage, single arm, study (TROJAN 2201)

The efficacy of checkpoint inhibitors are far from satisfied in lung cancer patients with liver metastases. Oncolytic virus can enhance the PD-1/PD-L1 antibody vitro/vivo. In this study, we evaluate safety and oncolytic H101 plus PD-1 Toripalimab for metastasis-lung advanced who have progressed failed after EGFR-TKIs, chemotherapy or treatment. refractory to previous several lines standard treatment were injected recombinant human adenovirus 5 (1012 vp 2×1012vp) locally metastases toripalimab (3mg/kg) systemic therapy every 2 weeks until progression intolerable toxicity. two primary end points investigator-assessed objective response rate (ORR) secondary included progression-free survival (PFS) disease control (DCR). Efficacy was assessed months by investigators according mRECIST v1.1 criteria. Blood samples collected prospectively. From January 26, 2021 July 15, 2022, ten enrolled received at least 1 cycle combination regimen. most common treatment-related adverse events (TRAEs) grade 1-2 fever, which occurred 9 (90%) 10 patients. No deaths other SAE judged be treatment-related. Six among 3 cycles regimen evaluable analyses as one patient lost follow-up. Two five (40%) (one small adenocarcinoma) acquired partial remission (PR) therapy, including remained 11 months. achieved stable (SD) adenocarcinoma patent (20%) had progressive diseases (PD). Our results confirm that type has shown an acceptable profile preliminary those treatment, deserved further investigation randomized trials.