June 03, 2014
Gilead Announces Updated Phase 2 Results for Investigational GS-9973 in Relapsed Chronic Lymphocytic Leukemia
-- Syk Inhibitor Demonstrates 49 Percent Overall Response Rate with an Estimated Progression-Free Survival Rate at 24 Weeks of 70 Percent in Previously Treated CLL Patients --
-- Data Presented at American Society of Clinical Oncology Annual Meeting --
“Most CLL patients eventually relapse following treatment, underscoring
the need for novel therapies targeting survival pathways that may enable
patients to obtain control of their disease without requiring
The efficacy analysis focuses on a cohort of 41 CLL patients with a median exposure of 32 weeks (range 1-53) in Study 102. Among this cohort, the Kaplan-Meier estimated PFS rate at 24 weeks was 70 percent (95 percent CI: 51-83 percent). Median PFS and median duration of response were not reached. At the time of data snapshot, 46 percent of patients (n=19) continued GS-9973 treatment. There was a 49 percent (n=20) overall response rate, of which all were partial responses. Ninety-five percent of evaluable patients (n=37/39) experienced tumor shrinkage, including all 25 patients with a chromosome 17p deletion and/or a mutation in the TP53 gene or other genetic abnormalities that have been linked to poor prognosis. Sixty-two percent of evaluable patients (n=24) achieved at least a 50 percent tumor reduction.
The safety of GS-9973 was also assessed in a larger population of 145
CLL or non-Hodgkin lymphoma (
Based on these data, Gilead plans to initiate new CLL study cohorts to include patients who have relapsed following treatment with other inhibitors of the b-cell receptor (BCR) pathway.
About Study 102
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 and
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. Additional information about clinical studies of GS-9973 can be found at www.clinicaltrials.gov. GS-9973 is an investigational product and its 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 bone marrow and blood 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. Gilead may also experience challenges in initiating new CLL study cohorts in the currently anticipated timelines and such studies may 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 March 31, 2014, 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
Patrick O’Brien, 650-522-1936
Nathan Kaiser, 650-522-1853