Phase II data on GS 9973 in B Cell Lymphoma-Gilead

Gilead Sciences has announced interim results from a single-arm, open-label Phase II study evaluating GS 9973 in patients with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Non-Hodgkin�s Lymphoma (NHL), including indolent NHL (iNHL), diffuse large B-cell Lymphoma and Mantle Cell Lymphoma. The data show that among patients with CLL who received at least eight weeks of GS 9973 monotherapy, 97% experienced a reduction in lymph node size. Of the 29 CLL patients included in the efficacy analysis, 69% achieved greater than 50% tumor shrinkage, including four of seven patients with a chromosome 17p deletion and/or a mutation in the TP53 gene, genetic abnormalities that have been linked to poor prognosis.

The safety of GS 9973 was also assessed in a population of 78 patients with CLL or NHL who had received at least four weeks of therapy. At the time of the data cut-off, 64% of patients were continuing with GS 9973 treatment, with a median exposure of 10 weeks (range: 1-24 weeks). Among the 78 patients in the safety analysis, 6% reported fatigue of Grade 3 or more. Results were presented at Annual Meeting of the American Society of Hematology.