ASCO Annual Meeting! Saturday 30 . A Phase III Study of Trabectedin (T) plus Pegylated Liposomal Doxorubicin (PLD) versus PLD for treatment of advanced-relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer.

Author(s): Robert L. Coleman, Bradley J. Monk, Roland Elmar Knoblauch, Trilok V. Parekh, Spyros Triantos, Raymond Scott Maul, Youn Choi Park, Thomas J Herzog; The University of Texas MD Anderson Cancer Center, Houston, TX; Division of Gynecologic Oncology, University of Arizona Cancer Center, Phoenix, AZ; Janssen Research & Development, LLC, Raritan, NJ; Division of Gynecologic Oncology, The University of Cincinnati Cancer Institute, Cincinnati, OH

Abstract Disclosures

Abstract:

Background:

Ovarian cancer (OVC) is the eighth most common cancer among women globally, with approximately 60%–70% of cases being diagnosed at an advanced stage (III or IV). Five-year survival rate for advanced stages is under 40%. In a previous pivotal trial, patients with OVC who relapsed after first-line platinum-based chemotherapy (PCT) demonstrated superior progression free survival when treated with the T+PLD combination vs. PLD monotherapy (7.3 vs. 5.8 months; HR = 0.79; p = 0.019). In a subgroup analysis by platinum free interval, T+PLD showed an improved overall survival (OS) for patients with Platinum Free Interval of 6–12 months (HR = 0.64) (J Clin Oncol. 2010 28:3107-14.).

Given this demonstrated efficacy, we are conducting a global phase III registration trial to investigate the OS of T+PLD vs. PLD in patients with platinum sensitive epithelial OVC, peritoneal or fallopian tube cancer, in the third-line setting. Methods: In this open-label, active-controlled trial, approximately 670 women who have received 2 prior lines of PCT will be enrolled at approximately 135 sites in 9 countries.

Key inclusion criteria: all women must be platinum sensitive (defined as no evidence of disease progression for ≥ 6 months after the last dose of first-line PCT), and demonstrated a partial or complete response to second line PCT. Key exclusion criteria: OVC with mucinous histology and > 2 prior lines of chemotherapy.

Patients will be stratified by Platinum Free Interval, ECOG performance status, BRCA 1 or 2 mutation status, and prior PLD therapy. Stratified patients will be randomized (1:1) to receive PLD (30 mg/m2, 1.5 h, i.v.) followed by T (1.1 mg/m2, 3 h, i.v.) every 3 weeks or PLD alone (50 mg/m2, 1.5 h, i.v.) every 4 weeks. Primary endpoint is OS.

Secondary endpoints include progression free survival, overall response rate (ORR), safety, and pharmacokinetics of T. Planned study duration is 64 months. An interim OS analysis is planned after 308 events.

Final OS analysis will be done after ≥ 514 events have been observed. As of 19 January 2015, 145 patients have been randomized (ClinicalTrials.gov #: NCT01846611).