Abstract 736P
Background
Patients with platinum-resistant ovarian cancer have a poor prognosis. Effective treatment options for these patients are limited. In this study (ANNIE), we evaluate the activity of niraparib combined with anlotinib in patients with platinum resistant recurrent ovarian carcinoma.
Methods
The ANNIE trial (NCT04376073) was a multicentre, single-arm, phase II study that evaluated the safety and activity of niraparib combined with anlotinib in patients with platinum resistant recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer cancer, and with measurable disease according to the Response Evaluation Criteria in Solid Tumors. Patients received oral niraparib 300mg/200mg once daily continuously and anlotinib 12mg on day 1-14 of each 21-day cycle thereafter until disease progression or intolerable toxicity. The primary objective was to assess objective response rate according to RECIST version 1.1. 40 cases are planned to be enrolled.
Results
Between May 22, 2020 and April 22, 2021, we enrolled 40 patients. Patients had received a median of four (range, 2-9) previous lines of therapy, only 3 patients had a deleterious germline BRCA1/2 mutation. The cut-off date of analysis was May 1, 2021, the median follow-up was 7.6 months (range, 0.2–11.1). At data cutoff, all but ten (2 voluntarily withdrew, 8 with progressive disease) of the patients were still on treatment. Twenty-six patients underwent imaging evaluation. The confirmed best overall response assessment showed 13 with partial responses, yielding the ORR of 50.0% (95% CI, 29.4%∼70.6%). The median duration of response and the median PFS were not reached. Drug-related grade 3 or worse treatment-emergent adverse events were occurred in 32.5% patients. The most common treatment emergent adverse events was hand-foot skin reaction (47.5%). No treatment-related death was recorded.
Conclusions
Niraparib in combination with anlotinib showed promising antitumor activity and tolerable toxicity in patients with platinum resistant recurrent ovarian cancer.
Clinical trial identification
NCT04376073.
Editorial acknowledgement
Legal entity responsible for the study
The Research Committee of the Sun Yat-sen University Cancer Center.
Funding
Zai Lab.
Disclosure
All authors have declared no conflicts of interest.