Ep-100+Paclitaxel To Overcome Taxane Resistance In Patients With Recurrent Lhrh-Receptor Expressing Ovarian Cancer.

5582 Background: EP-100 (E) is a synthetic cytolytic peptide conjugated to Luteinizing Hormone Releasing Hormone (LHRH). It targets cells that overexpress LHRH receptors and kills by membrane disruption. Preclinical studies demonstrate synergy between E and paclitaxel (P). This randomized phase 2 trial explored the efficacy, safety and toxicity of E+P in women with advanced ovarian cancer. Methods: Run-in” dose-escalation specified at least 1 patient would be treated with E per dose level. Patients were randomized 1:1 to receive weekly P (80 mg/m2 IV) + biweekly E (30 mg/m2 IV, E+P) vs. weekly P (80 mg/m2 IV). Unlimited prior regimens were allowed. Central IHC for tumoral LHRH receptors was required. The 10 endpoint was overall response rate (ORR) per RECIST 1.1. The 20 endpoint was disease control rate (DCR = CR+PR+SD). For an improvement in ORR and DCR of at least 30% with E+P vs. P, a sample size of 20 patients/arm estimated CIs of 6-47% (P alone) vs. 27-73% (E+P). Patients progressing on P were allow...