Introduction and Objective
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.
Methodology
The ANNIE trial was a multicentre, single-arm, phase 2 study that evaluated the safety and activity of niraparib combined with anlotinib in patients (≥18 & ≤70 years) with recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer cancer whose disease recurred in less than 6 months after the last administered platinum therapy. 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 (ORR; complete plus partial responses). 40 cases are planned to be enrolled.
Results
Between May 22, 2020 and August 3, 2020, we enrolled 9 patients (median age, 54 years [range, 44-64 years]). Patients had received a median of five (range, 2-8) previous lines of therapy. All but two (1 voluntarily withdrew, 1 with disease progression) of the patients were still on treatment, the longest has been taking medication for more than 8 cycles. Eight patients underwent imaging evaluation, including 1 confirmed complete responses, 5 with confirmed partial responses, 1 with stable disease, 1 with progressive disease. No drug-related grade 3 or worse treatment-emergent adverse events were detected, the most common treatment emergent adverse events were hypertension (5 of 9 patients), hand-foot skin reaction (4 of 9 patients), hoarseness (4 of 9 patients). Enrollment was ongoing so far.
Conclusion
It seems niraparib in combination with anlotinib is tolerable, with promising antitumor activity for patients with platinum resistant recurrent ovarian cancer.  Besides, we observed unusual safety signals in the combination (more hoarseness and less hematological toxicities). The conclusion can be clarified after the research is completed.

Disclosures
Trial registration ClinicalTrials.gov identifier: NCT04376073, Funding: Zai Lab, The authors declare no conflicts of interest.

PRELIMINARY RESULTS OF ANLOTINIB AND NIRAPARIB DUAL THERAPY EVALUATION IN PLATINUM-RESISTANT RECURRENT OVARIAN CANCER（ANNIE）: A MULTICENTER, SINGLE-ARM, PHASE 2 TRIAL