Abstract B67: IG-001: A non-biologic nanoparticle paclitaxel for the treatment of ovarian cancer

Abstract

Abstract Introduction: IG-001(Genexol-PM), like nab-paclitaxel, is a polymer bound nanoparticle paclitaxel. IG-001 utilizes biodegradable di-block copolymer composed of methoxy poly (ethylene glycol)-poly (lactide) to form nanoparticles with Paclitaxel containing hydrophobic core and a hydrophilic shell. IG-001 is being developed for difficult to perfuse hypoxic tumors such as pancreatic cancer and ovarian cancer. Methods: Clinical efficacy was evaluated across multiple cancer indications including metastatic breast cancer (MBC), non small cell lung cancer (NSCLC), pancreatic cancer and ovarian cancer. Phase I ovarian trial design: six patients/dose level were treated with IG-001 at 220, 260, and 300 mg/m2. Phase II ovarian trial design: randomized, two-arm trial, primary advanced epithelial ovarian cancer consisting of 100 pts (50/each arm). Control Arm: Solvent based paclitaxel 175mg/m2 IV + Carboplatin 5 AUC IV, 3 weeks, 6 cycles and Experimental Arm: IG-001 260mg/m2 IV + Carboplatin 5 AUC IV 3 weeks, 6 cycles. Phase III ovarian trial design- planning phase to consist of therapeutic drug monitoring and biomarker testing. Results: Clinical trials conducted with IG-001 demonstrated significant antitumor activities comparable to historical data for Abraxane. Across three cancer indications (MBC, NSCLC, and Pancreatic Cancer), IG-001 was more active than historical Taxol. Since Pancreatic Cancer is known to be poorly-perfused, IG-001 activity in this indication is consistent with it being able to penetrate poorly-perfused tumors. Conclusions: IG-001 is effective across multiple cancer indications. Clinical development of IG-001 in ovarian cancer is ongoing. Phase I data was encouraging and phase II data forthcoming. IG-001 could be considered to be superior to Cremophore based paclitaxel because of the possibilities of delivering higher paclitaxel dose without additional toxicities. Phase III trial design incorporating therapeutic drug monitoring and biomarker testing should further improve on IG-001 clinical activities. Citation Format: Larn Hwang, Catherine Cheng, Vuong Trieu. IG-001: A non-biologic nanoparticle paclitaxel for the treatment of ovarian cancer. [abstract]. In: Proceedings of the AACR Special Conference on Advances in Ovarian Cancer Research: From Concept to Clinic; Sep 18-21, 2013; Miami, FL. Philadelphia (PA): AACR; Clin Cancer Res 2013;19(19 Suppl):Abstract nr B67.