757P - The efficacy and safety of recombinant human adenovirus type 5 (H101) intra-tumor therapy in patients with recurrent or metastatic cervical cancer: A prospective, open-label, single-arm study

Background

H101 has promising efficacy and favorable safety in patients with persistent /recurrence/metastasis (P/R/M) gynecological cancer, but the evidence regarding the effect of H101 on cervical cancer remains rare. Thus, the purpose of this study is to evaluate the efficacy and safety of H101 intra-tumor injection in P/R/M cervical cancer.

Methods

This is a prospective, open-label, single-arm study, with an expected sample size of 60. P/R/M cervical cancer patients who had received at least one line of systemic therapy or could not tolerate chemotherapy were eligible. Patients were given H101 intro-tumor injection (0.5-1.5×10¹²) viral particles from day 1 to day 5 combined with or without radiotherapy in sequential, 3 weeks for a cycle (1-4 cycles totally). The primary endpoint is local control (LC) and the secondary endpoints include objective response rate (ORR), progression-free survival (PFS), overall survival (OS) and adverse events (AEs). This trial was registered at www.clinicaltrials.gov with identifier number NCT 05051696.

Results

Between September 2021 to April 2023, 53 patients were enrolled, in which 49 patients (92.45%) completed at least 1 tumor assessment with a median follow-up time of 8 months (95%CI: 7-11months). The LC rate at 3 months was 73.5% (95%CI: 60.7%-86.3%), and the median PFS and OS were currently not reached. The ORR was 69.4% (95%CI: 56%-82.8%), and the disease control rate (DCR) was 81.6% (95%CI: 70.4%-92.9%) by RECIST1.1. The most frequently reported AEs were fever (62.8%), fatigue (32.65%), vomiting (20.41%), bleeding (16.3%), pain (16.3%) and bird-flue like symptoms (16.3%). All frequently occurring AEs were grade 1 or 2. High grade AE was only observed in 3 patients with rectovaginal fistula grade 3. Neither unexpected safety signals nor treatment related death occurred.

Conclusions

We present here for the first time that H101 is a strong candidate for virotherapy in P/R/M cervical cancer. These results demonstrate that H101 combined with or without radiotherapy could improve clinical outcomes significantly in patients with P/R/M cervical cancers with acceptable toxicity.

Clinical trial identification

NCT05051696.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.