185MO - Preliminary results of niraparib combined with brivanib or toripalimab dual therapy evaluation in recurrent, metastatic and persistent cervical cancer (CQGOG0101): An open-label, two cohorts, phase II clinical trial

Background

The aim of this study (CQGOG 0101, NCT04395612) is to evaluate the safety and activity of Niraparib (an oral PARP1/2 inhibitor) combined with brivanib (an anti-angiogenesis inhibitor) or Toripalimab (a PD-1 inhibitor) in patients with recurrent, metastatic, or persistent cervical cancer.

Methods

30 patients were planned to be enrolled.Eligible patients were aged 18–70 years with measurable lesions and had an ECOG performance status of 0-2. Two cohorts were included in the study: Cohort 1：Subjects received oral Niraparib 200 mg and Brivanib 400 mg once daily. Cohort 2：Subjects received oral Niraparib 200 mg once daily and Intravenous Toripalimab 240 mg every 21 days. Treatment until until disease progression, intolerable toxicity, or withdrawal of consent. Primary endpoint was the objective response rate (ORR) assessed by RECIST version 1.1. Secondary endpoints included disease control rate (DCR), duration of response (DOR) and safety.

Results

Between May 8th, 2020 and June 22nd, 2022, 23 patients (median age, 50 years old [28-73]) were enrolled. Patients had received a median of two (1-3) previous lines of platinum-based therapy. All of 23 patients had distant metastatic lesions. In Cohort 1, 9 patients had underwent at least one post baseline tumor assessment (To deadline for submission), including 1 confirmed partial response, 4 with stable disease, 4 with progressive disease, the ORR is 11%.No drug-related grade 3 or worse treatment-emergent adverse events were detected. In Cohort 2,13 patients had underwent at least one post baseline tumor assessment (To deadline for submission),including 8 confirmed stable disease, 4 with progressive disease, 1 withdrawal of consent. The median duration of treatment has not met yet. Treatment of Cohort 2 is still ongoing (Median follow-up is 2 months). Grade 3 or worse TEAEs were detected in 3 subjects.

Conclusions

The Cohort 1 (Niraparib combined with Brivanib) seems to show a similar efficacy compared to other recurrent cervical cancer late-line therapies. The treatment of the Cohort 2 (Niraparib combined with Toripalimab) is still ongoing and final data will be reported later.

Clinical trial identification

NCT04395612.

Editorial acknowledgement

The authors thank the patients and their families.

Legal entity responsible for the study

The authors.

Funding

Zai Lab.

Disclosure

All authors have declared no conflicts of interest.