Double-Blind, Placebo-Controlled, Randomized, Phase 2 Study To Evaluate The Efficacy And Safety Of Maintenance Therapy With Anti-Ta-Muc1 Monoclonal Antibody Pankomab After Chemotherapy In Patients With Recurrent Epithelial Ovarian Carcinoma.

TPS5622 Background: PankoMab is a potent humanized glyco-engineered IgG1 recognizing the tumor-specific carbohydrate/protein epitope TA-MUC1 expressed virtually only on tumor cells of a wide variety of cancers with up to 95% expression in ovarian (OvCa), NSCL and breast cancers. Phase 1 study results were presented at ECCO 2013 (C. Sessa et al., Abstract 849). Drug was well tolerated, clinical benefit (CB: CR, PR and SD) observed in pts. with solid tumors with CB rate of 40% incl. 1 CR of 485 d out of 20 pts. with OvCa. OvCa was selected as target indication for a randomized phase 2 maintenance therapy trial of PankoMab in TA-MUC1 positive pts. Methods: Study design: Randomized, placebo-controlled, double-blind Phase 2 multinational study at 40 sites in 8 European countries. Pts. with outcome of CR, PR or SD after most recent line of chemotherapy (CT) are randomized in a 2:1 ratio for treatment with either PankoMab or placebo. Treatment regimen: 500 mg starting dose followed by 1700 mg 7 d later, to be repeated q3w. Pt. stratification by: (i) Duration of treatment-free interval of the most recent platinum based CT preceding the CT to which the pt. has just responded, (ii) Type of response to CT the patient has just received, (iii) Number of prior lines of CT. Sample size: Total of210 assuming median PFS of 4 m. in placebo and 6 m. in PankoMab arm (HR 0.67; overall 1-sided significance level 0.05). Study endpoints: Primary: PFS using modified immune related RECIST v1.1 criteria; secondary: OS, tumor response, safety, QoL, correlation of efficacy/safety with TA-MUC1 IHC score, soluble TA-MUC1 levels, Fc□ receptor status, and PK. Main entry criteria: TA-MUC1 pos. tumor samples, recurrent epithelial OvCa; 2 – 4 lines of previous CT; CR, PR, or SD after most recent CT; ≤5 wk. interval between last CT dose and randomization.; treatment-free interval of ≤12 mo. before most recent CT; sensitive or resistant but not refractory to most recent platinum based CT; ECOG PS ≤1. Current status: All sites initiated, 36 pts. pre-screened, 6 pts. enrolled, results expected 2015. EudraCT: 2013-000931-28. Clinical trial information: NCT01899599.