December 07, 2013
Gilead Announces Interim Phase 2 Results for GS-9973 in Previously Treated Chronic Lymphocytic Leukemia
-- Data Presented at the 55th American Society of Hematology Annual Meeting --
“Most patients with CLL eventually develop resistance to currently
available therapies,” said
Of the 29 CLL patients included in the efficacy analysis, 20 (69 percent) achieved greater than 50 percent 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 non-Hodgkin’s lymphoma (
Among the 78 patients in the safety analysis, five (six percent) reported Grade ≥3 fatigue. Reversible Grade ≥3 transaminase elevations (a measure of liver function) were reported in nine patients (12 percent). Eleven patients (14 percent) discontinued treatment due to adverse events. Four patients died during the study, three from progressive disease and one from septic shock.
About the Study
This Phase 2, open-label, single-arm safety and efficacy study is
evaluating GS-9973 (800 mg twice daily) in patients with relapsed or
refractory CLL or
GS-9973 is an investigational, targeted, reversible oral inhibitor of spleen tyrosine kinase (Syk), a protein that is critical for the activation, proliferation and survival of B lymphocytes. Combination therapy with GS-9973 and idelalisib, Gilead’s investigational, targeted, oral inhibitor of PI3K delta, is also being evaluated in a Phase 2 trial of patients with relapsed or refractory CLL, iNHL and other lymphoid and hematological malignancies.
Additional information about clinical studies of GS-9973 and Gilead’s other investigational cancer agents can be found at www.clinicaltrials.gov. GS-9973 and idelalisib are investigational products and their safety and efficacy have not been established.
About Chronic Lymphocytic Leukemia
CLL is a slow-growing cancer in which the bone marrow overproduces white
blood cells, leaving less room in the blood and bone marrow for other
types of blood cells. It is the most common leukemia in adults in the
About Gilead Sciences
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the possibility of unfavorable results from clinical trials involving GS-9973, including in combination with idelalisib or other agents. Gilead may also experience challenges in enrolling patients in clinical studies, requiring those studies to be modified or delayed. Further, Gilead may make a strategic decision to discontinue development of GS-9973 if, for example, Gilead believes commercialization will be difficult relative to other opportunities in its pipeline. As a result, GS-9973 may never be successfully commercialized. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2013, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.
For more information on Gilead Sciences, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000
Gilead Sciences, Inc.
Patrick O’Brien, 650-522-1936 (Investors)
Nathan Kaiser, 650-522-1853 (Media)