A Phase Ii Trial Of Iniparib (Bsi-201) In Combination With Gemcitabine/Carboplatin (Gc) In Patients With Platinum-Sensitive Recurrent Ovarian Cancer.

5004 Background: GC is an established chemotherapy combination for patients with platinum-sensitive recurrent ovarian cancer, with an associated overall response rate (ORR) of 47.2% (Pfisterer et al. JCO 2006; 24:4699). Addition of iniparib (BSI-201), an anticancer agent with poly(ADP-ribose) polymerase inhibitory activity, to GC potentiates the activity of GC alone, with low incremental toxicities, in patients with metastatic triple-negative breast cancer (O’Shaughnessy et al. NEJM 2011). This study was designed to evaluate the efficacy and safety of iniparib in combination with GC in patients with platinum-sensitive recurrent ovarian cancer. Methods: This multicenter, single-arm phase 2 study used a Simon two-stage design (Stage I n=17; total N=41). Eligible patients were ≥18 years with a histological diagnosis of epithelial ovarian carcinoma, fallopian tube cancer, or primary peritoneal carcinoma and demonstration of platinum-sensitive disease, defined by relapse ≥6 months following primary treatment termination. Carboplatin (AUC 4; IV; day 1), gemcitabine (1000 mg/m2; IV; days 1 and 8), and iniparib (5.6 mg/kg; IV; days 1, 4, 8, and 11) were given on a 21-day cycle. The primary endpoint was overall response rate (ORR; RECIST 1.0); secondary endpoints were safety and progression-free survival (PFS). Results: Analysis from the first 17 patients (who completed Stage 1) demonstrated an ORR of 70.6%, consisting of 12 confirmed responses. Preliminary analyses did not indicate a relationship between BRCA status and objective response. Safety profiles were consistent with those observed in previous clinical studies of iniparib + GC. Conclusions: Iniparib + GC demonstrated activity in patients with platinum-sensitive recurrent ovarian cancer, with increase in ORR, compared with data from previous studies (70.6% vs. 47.2%). No unexpected toxicities have been reported. Updated data from all 41 enrolled patients will be presented. Clinicaltrials.gov number, NCT01033123.