...Germline and/or systemic BRCA1/2 mutation confirmed by central laboratory; 4....

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....Senaparib demonstrated clinically meaningful antitumor activity in OC...

The INV-assessed confirmed ORR was 59.3% (95% CI, 48.4-69.2) and disease control rate (DCR) was 93.4% (95% CI, 86.2-97.5). Median DOR was 10.3 mo (95% CI, 8.2-12.0). Median PFS was 11.1 mo (95% CI, 8.3-13.8). Median OS was 31.6 mo (95% CI, 25.2-not reached) with 90% and 69% of 1 year and 2 years survival rate....Senaparib demonstrated clinically meaningful antitumor activity and manageable safety profile in BRCA1/2 mutated recurrent PSOC.

As in the ITT population, a greater proportion of patients with ovarian cancer in the BRCAmut+ subgroup experienced a reduced tumor size compared with their non-ovarian counterparts…Senaparib was well tolerated, had good PK properties, and showed encouraging signs of antitumor activity in Chinese patients with previously treated, advanced solid tumors, as well as in a subpopulation of patients harboring BRCAmut+.

In 17 BRCA+ ovarian cancer patients, the ORR is 24% and DCR is 82%....further confirmed senaparib is well-tolerated, with mild to moderate haematologic toxicity as the most frequent TRAEs and showed encouraging signs of clinical activity.

...cohort enrolled patients with BRCA mutated (BRCA+) advanced solid tumors….In 8 evaluable ovarian cancer patients, ORR was 38% and DCR was 75%. A prolonged (> 20 months) PR response was observed in one BRCA+ ovarian cancer patient...Senaparib demonstrated encouraging clinical benefit and a favorable tolerability profile in patients with advanced solid tumour.