Article Text
Abstract
Introduction Senaparib (IMP4297) showed promising antitumor activity for advanced ovarian cancer (OC). This study aimed to evaluate the efficacy and safety of senaparib in patients(pts) with BRCA1/2 mutated platinum sensitive recurrent OC. Here we assessed the efficacy by prior therapies and types of platinum sensitive.
Methods This open label, multicenter, single arm, phase II study (NCT04089189) enrolled recurrent OC pts with germline and/or somatic BRCA mutation who had previously received ≥ 2 lines of platinum-based chemotherapy(CT). Senaparib (100 mg oral QD) was administered until disease progression or unacceptable toxicity. The primary endpoint was independent review committee (IRC)-assessed objective response rate (ORR) per RECIST v1.1.
Results As of 30 Jan 2023, 93 pts were enrolled. 59%/41% pts were partially/fully platinum sensitive. Median lines of prior systemic chemotherapy(CT) was 2 (range 2–7), and 71%/29% received 2/≥ 3 lines of CT. After a median follow up of 15.7 months, efficacy was assessed in 91 pts who received treatment of senaparib and ≥ 1 tumor evaluated and met the criteria for the response evaluable set. IRC had not finished the assessment and the efficacy assessed by investigators was showed in table 1.
Conclusion/Implications Senaparib demonstrated clinically meaningful antitumor activity in OC pts of fully or partially platinum sensitive who had previously received ≥ 2 lines of CT.