Efficacy and Safety of Recombinant Human Adenovirus Type 5 (H101) in Persistent, Recurrent, or Metastatic Gynecologic Malignancies: A Retrospective Study

Abstract

BackgroundTo assess the efficacy and safety of recombinant human adenovirus type 5 (H101) in patients with persistent, recurrent, or metastatic gynecologic malignancies.MethodsThe study retrospectively enrolled patients with persistent/recurrent/metastatic gynecologic malignancies who received H101-containing treatment at The First Affiliated Hospital of Xi’an Jiaotong University from September 1, 2019 to September 30, 2021. H101 was injected intratumorally into target lesions and dosage was calculated based on tumor diameter once a day for five consecutive days. The primary endpoint was local control (LC) rate. Secondary endpoints included objective response rate (ORR), duration of response (DOR) and progression-free survival (PFS). Safety was the exploratory endpoint. Depending on prior treatment, patients received H101 either as monotherapy or as a combination therapy.ResultsTotally, 29 patients were enrolled in the study. Median follow-up was 6.3 months (range: 3.2-27.9) from data analysis cut-off on December 31, 2021. The LC rate at 3 months was 44.8%, while ORR was 72.4%. Median DOR and PFS rates were not determined. The DOR rate, PFS rate at 6 and 12 months were 88.1%, 74.6% and 70.5%, 62.2%, respectively. Responses were observed in all four cancer types. Most treatment-related adverse events (90.5%) were grade 1 or 2, with the most common being fever (70%). Clinically significant adverse events were uncommon (7.9% in grade 3 and 1.6% in grade 4). No treatment-related deaths occurred.ConclusionOur study showed that H101 (either monotherapy or combination therapy) has promising efficacy and favorable safety in patients with persistent, recurrent, metastatic gynecologic malignancies.

New hopes for the breast cancer treatment: perspectives on the oncolytic virus therapy

“…In China in 2005 another OV, Oncorine, was approved by the National Medical Products Administration (NMPA) of China for treating nasopharyngeal carcinoma and advanced head and neck cancer ( 64 ). Oncorine is a genetically modified (deletion of E1b55K ) human adenovirus type 5 called H101, which was developed by the Chinese company Sunway Biotech ( 65 ).…”

“…22 patients responded to the treatment - significant tumour regression and reduction in necrotic tissue were observed as well as longer progression-free survival. Additionally, the objective response rate for radiotherapy was 72.4%, suggesting that Oncorine may increase the radiotherapy sensitivity ( 64 ). Side effects were similar to those that were previously reported, such as pyrexia, nausea, vomiting, fatigue, and pain with sometimes bleeding in the place of injection ( 60 ).…”

E4orf1: The triple agent of adenovirus – Unraveling its roles in oncogenesis, infectious obesity and immune responses in virus replication and vector therapy

“…Deleted for E1B–55K and E3, the tumor-specific replication is thought to be due to the lack of E1B–55K-mediated p53 deactivation as well as the loss of E1B–55K-mediated late viral RNA export [ 320 ]. Currently, Oncorine is being explored in other cancer therapies, and overall, more than 30 ongoing clinical trials are investigating oncolytic AdVs with several modifications in the viral genome to increase cancer cell selectivity [ 316 , [321] , [322] , [323] ]( https://clinicaltrials.gov/ , accessed on June 2023).…”

Effectiveness and safety of human type 5 recombinant adenovirus (H101) in malignant tumor with malignant pleural effusion and ascites: A multicenter, observational, real‐world study

“…The application of OVs in various malignancies has become a promising therapeutic strategy 8–10 . Recombinant human adenovirus type 5 (H101) is a genetically modified oncolytic adenovirus that can selectively replicate in p53 mutated tumors and induce p53 accumulation during replication to produce direct and selective cytotoxic effects on tumor cells 11 . As p53 is the most frequently mutated gene in human cancers, H101 has exhibited anticancer properties in a variety of cancers, such as head and neck carcinoma, gastric cancer, and hepatocellular carcinoma 12–14 .…”