Gilead Sciences, Inc. (Nasdaq: GILD) today announced interim results
from a single-arm, open-label Phase 2 study evaluating GS-9973, an
investigational oral inhibitor of spleen tyrosine kinase (Syk), for the
treatment of patients with relapsed or refractory hematologic
malignancies. The data show that among patients with chronic lymphocytic
leukemia (CLL) who received at least eight weeks of GS-9973 monotherapy,
97 percent (n=28/29) experienced a reduction in lymph node size.
Detailed results will be presented today during a poster session at the
55th Annual Meeting of the American Society of Hematology (ASH) in New
Orleans (Abstract #1634).
“Most patients with CLL eventually develop resistance to currently
available therapies,” said Jeff Sharman, MD, Willamette Valley Cancer
Institute and Research Center – River Bend. “This underscores the
importance of identifying new treatments for patients with CLL. The B
cell receptor signaling pathway is a novel area of focus for
investigational therapies in CLL. GS-9973 targets the Syk protein, which
initiates most signaling from the B cell receptor. Response rates
observed in this interim analysis support that GS-9973 has promising
clinical activity in CLL to be further explored and developed.”
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 (NHL) who had received at least four
weeks of therapy. At the time of the data cut-off, 50 patients (64
percent) 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, 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 NHL, including indolent NHL (iNHL), diffuse large
B-cell lymphoma and mantle cell lymphoma. The median age of the patients
included in the safety analysis presented today was 72 years. These
patients had received a median of two prior treatment regimens before
study entry. The primary endpoint of the study is progression-free
survival. Patients are allowed to continue daily dosing as long as they
benefit from therapy. At the time of the data cut-off, it was too early
to quantitate drug activity in the NHL population. The study is ongoing.
About GS-9973
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
United States, occurring typically in older individuals, and it can lead
to life-threatening complications, including serious infections and
anemia. In 2013, there were an estimated 16,000 new CLL diagnoses in the
United States and 4,500 deaths related to this cancer.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops
and commercializes innovative therapeutics in areas of unmet medical
need. The company’s mission is to advance the care of patients suffering
from life-threatening diseases worldwide. Headquartered in Foster City,
California, Gilead has operations in North and South America, Europe and
Asia Pacific.
Forward-Looking Statement
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
Copyright Business Wire 2013