1. The use of recombinant L-IFN adenovirus in patients with recurrent or refractory advanced solid tumours was well tolerated with few adverse events greater than Grade 3.
2. Recombinant L-IFN adenovirus injections showed preliminary efficacy against advanced solid tumours.
Evidence Rating Level: 2 (Good)
Oncolytic viruses are viruses that selectively induce cell lysis in tumour cells while preserving the health of normal cells. Prior studies have shown that the use of adenoviruses as a viral vector alone has limited efficacy in the management of tumours. This single-center open-label study aimed to investigate a novel strategy involving an adenovirus viral vector harboring a recombinant L-IFN genome (YSCH-01) which may allow for the expression of the anticancer L-IFN proteins within tumour cells to enhance tumour cell death. 14 subjects with advanced solid tumours were enrolled, with 9 undergoing a dose escalation phase and 5 undergoing a dose expansion phase with 13 participants being included in the full analysis set (mean age, 61.08±9.72 years). The primary endpoint of the study was the safety of YSCH-01 as determined by ratio of the incidence and characteristics of adverse events (AEs) compared to serious adverse events. During the dose escalation phase, no patient experienced dose-limiting toxicity. In total, 119 AEs were experienced in 12 subjects, with 71 resolving by the data cut-off date. The overall incidence for AEs was 92.3% while the incidence of AEs greater than Grade 3 was 7.7%, results comparable to safety data reported in studies of similar drugs. Preliminary efficacy was observed with an overall response rate of 27.3% (95% CI, 6.02% to 60.97%) and a disease control rate of 81.8% (95% CI, 48.22% to 97.72%). Overall, this study found that the novel recombinant L-IFN adenovirus drug, YSCH-01, is well tolerated in patients and has demonstrated preliminary efficacy with further study warranted.
Click to read the study in BMJ
Image: PD
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