-- Study 116 Stopped for Positive Efficacy in October; Met Primary
Endpoint of Progression-Free Survival and Secondary Endpoints of Overall
Response, Lymph Node Response and Overall Survival --
-- Data to be Presented During Late-Breaking Abstracts Session at
American Society of Hematology Annual Meeting --
FOSTER CITY, Calif.--(BUSINESS WIRE)--Nov. 18, 2013--
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the company’s
Phase 3 study (Study 116) evaluating idelalisib in combination with
rituximab in previously-treated chronic lymphocytic leukemia (CLL)
patients who were not fit for chemotherapy was accepted for presentation
during a late-breaking abstracts session at the Annual Meeting of the
American Society of Hematology (ASH) in New Orleans (Abstract #LBA-6).
Detailed results from the study will be presented at ASH on December 10,
2013.
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.
“Patients with relapsed CLL have limited treatment options and are often
not able to tolerate chemotherapy,” said Richard R. Furman, MD, Richard
A. Stratton Assistant Professor of Clinical Medicine, Division of
Hematology/Oncology, Weill Cornell Medical Center / New York
Presbyterian Hospital. “Based upon the results of this study
demonstrating significant improvements in progression-free and overall
survival, idelalisib represents an important addition to the
armamentarium for patients living with this life-threatening disease.”
Study 116 was stopped early based on a pre-specified interim analysis
performed by an external Data Monitoring Committee (DMC) showing a
highly statistically significant effect on the primary endpoint of
progression-free survival (PFS).
Safety was in line with previous observations, and was largely
consistent with advanced disease patients receiving CD20 antibody
therapy.
Additional details contained in the Study 116 abstract are available at www.hematology.org/2013abstracts.
These data in CLL support Gilead’s plans for regulatory filings for
idelalisib in the United States and European Union. On September 11,
2013, Gilead submitted a New Drug Application (NDA) to the U.S. Food and
Drug Administration (FDA) for idelalisib for the treatment of refractory
indolent non-Hodgkin’s lymphoma (iNHL). Following Gilead’s NDA
submission for iNHL, FDA granted idelalisib a Breakthrough Therapy
designation for CLL in relapsed patients based on results from Study
116. Gilead is now engaging in a dialogue with the FDA regarding a
regulatory filing in CLL. Gilead filed for approval in iNHL and CLL with
the European Medicines Agency (EMA) on October 28, 2013.
About Study 116
Study 116 was a randomized, double-blind, placebo-controlled, Phase 3
study evaluating the efficacy and safety of idelalisib in combination
with rituximab. The study enrolled 220 adult patients at approximately
70 study sites in the United States and Europe. Eligible patients had
previously treated recurrent CLL, with measurable lymphadenopathy that
had progressed within 24 months since completion of prior therapy. The
patients required treatment (based on IWCLL criteria) but were not fit
to receive cytotoxic therapy. Patients were randomized to receive eight
infusions of rituximab over 24 weeks plus either idelalisib (150 mg) or
placebo taken orally twice daily continuously until disease progression
or unacceptable toxicity. Patients from Study 116 randomized to
idelalisib will continue receiving idelalisib and patients in the
control arm (placebo plus rituximab) were eligible to receive open-label
idelalisib therapy in an extension study.
About Idelalisib
Idelalisib is an investigational, highly selective oral inhibitor of
phosphoinositide 3-kinase (PI3K) delta. PI3K delta signaling is critical
for the activation, proliferation, survival and trafficking of B
lymphocytes and is hyperactive in many B-cell malignancies. Idelalisib
is being developed both as a single agent and in combination with
approved and investigational therapies.
In addition to Study 116, the development program in CLL includes two
ongoing Phase 3 studies of idelalisib in previously treated patients.
Gilead’s clinical development program for idelalisib in iNHL includes a
Phase 2 study in highly refractory patients (Study 101-09) and two Phase
3 studies of idelalisib in previously treated patients. Combination
therapy with idelalisib and GS-9973, Gilead’s novel spleen tyrosine
kinase (Syk) inhibitor, also is being evaluated in a Phase 2 trial of
patients with relapsed or refractory CLL, iNHL and other lymphoid
malignancies.
Additional information about clinical studies of idelalisib and Gilead’s
other investigational cancer agents can be found at www.clinicaltrials.gov.
Idelalisib and GS-9973 are investigational products and their safety and
efficacy have not been established.
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
idelalisib, including in combination with GS-9973 or other product
candidates. Gilead also faces risks related to its ability to file for
U.S. regulatory approval of idelalisib for CLL in the currently
anticipated timelines. Gilead also faces risks related to its ability to
enroll patients in Phase 3 studies and may need to modify or delay these
studies. In addition, FDA, EMA and other regulatory agencies may not
approve idelalisib for the treatment of iNHL or CLL in the anticipated
timelines or at all, and any marketing approval may have significant
limitations on its use. As a result, idelalisib may never be
successfully commercialized. Further, Gilead may make a strategic
decision to discontinue development of idelalisib, as a single agent or
in combination with other products if, for example, Gilead believes
commercialization will be difficult relative to other opportunities in
its pipeline. 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 at1-800-GILEAD-5 or 1-650-574-3000.
Source: Gilead Sciences, Inc.
Gilead Sciences, Inc.Patrick O’Brien, 650-522-1936 (Investors)Nathan
Kaiser, 650-522-1853 (Media)
