GS-9973: Additional Phase II data

Data from 41 evaluable chronic lymphocytic leukemia (CLL) patients who received twice-daily 800 mg oral GS-9973 for a median of 32 weeks in the single-arm, open-label, U.S. Phase II Study 102 showed that GS-9973 led to an ORR of 49% (all partial responses) and an estimated 24-week PFS rate of 70%. Median PFS and duration of response have not yet been reached. Additionally, 95% of evaluable patients (n=39) experienced tumor shrinkage, including all 25 patients with a deletion of chromosome 17p (del17p) and/or a mutation in the tumor protein p53 ( TP53; p53) gene or other genetic abnormalities linked to poor prognosis. Furthermore, 62% of evaluable patients (n=24) achieved a >=50% tumor reduction. Data were presented at the American Society of Clinical Oncology meeting in Chicago. The trial is enrolling about 280 patients with relapsed or refractory CLL or non-Hodgkin’s lymphoma (NHL), including newly added cohorts of CLL patients who have relapsed following treatment with other inhibitors of the B cell receptor pathway. Gilead reported interim data from the trial last December (see BioCentury, Dec. 23, 2013). ...