October 09, 2013
Gilead to Stop Phase 3 Study 116 of Idelalisib in Chronic Lymphocytic Leukemia Early Because of Positive Risk-Benefit
“Given the significant unmet medical need in CLL, particularly in this
population of patients who are not fit for chemotherapy, we are pleased
that idelalisib has shown a clinically meaningful benefit for patients,”
Patients from Study 116 randomized to idelalisib will continue receiving idelalisib and patients in the control arm (placebo plus rituximab) will become eligible to receive open-label idelalisib therapy in an extension study. Gilead is also planning an expanded access program (EAP) for patients with recurrent CLL who are not fit for chemotherapy and require treatment.
A new drug application (NDA) for idelalisib was submitted for refractory
indolent non-Hodgkin’s lymphoma (iNHL) on
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 with previously treated recurrent CLL who had measureable lymphadenopathy with disease progression less than 24 months following completion of prior therapy, and who required treatment but were not fit to receive cytotoxic therapy. Eligible 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 who progressed on Study 116 were eligible to receive active idelalisib therapy in a double-blind extension study (Study 117).
Idelalisib is an investigational, highly selective and potent 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 a Phase 2 study in double-refractory iNHL, Gilead’s clinical development program for idelalisib includes two Phase 3 studies of idelalisib in patients with previously treated iNHL and three Phase 3 studies of idelalisib in patients with previously treated CLL. 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 yet 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,
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 may also be unable to file for regulatory approval
for idelalisib for CLL with the
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)