June 17, 2013
Gilead Announces Interim Phase 2 Data for Idelalisib Showing Response in Refractory Indolent Non-Hodgkin’s Lymphoma
-- 53.6 Percent Overall Response Rate and Median Duration of Response of 11.9 Months in Heavily Pre-Treated Patients --
-- Data to be Presented at the
“Despite the progress achieved in recent years, most patients suffering
from indolent non-Hodgkin’s lymphoma will progressively become resistant
to currently available treatments. Therefore, there is a significant
unmet medical need for novel therapies,” said
The overall response rate observed in the study was 53.6 percent (n=67; 95 percent CI: 44.5, 62.6) with five complete responses (four percent), 60 partial responses (48 percent), two minor responses and 46 patients with stable disease (36.8 percent). The overall response rate was highly consistent across all subgroups analyzed. Among patients who responded, the median duration of response was 11.9 months and the median time to response was 1.9 months (1.8, 3.7). Median progression-free survival for all patients was 11.4 months. Most patients (89 percent) experienced some shrinkage in lymph node size.
The most common Grade ≥3 adverse event was diarrhea (10 percent). Grade ≥3 transaminase elevations (measure of liver function) were reported via central laboratory testing in 13 percent of patients; Grade ≥3 neutropenia occurred in 26 percent of patients. Sixteen percent of patients discontinued due to adverse events. The study is ongoing.
About Study 101-09
Study 101-09 is a Phase 2, open-label, single-arm efficacy and safety study of idelalisib in patients with previously treated iNHL that is refractory both to rituximab and to alkylating-agent-containing chemotherapy (refractory defined as no response while on therapy or progression within six months of completion of therapy).
The study enrolled 125 patients from approximately 50 study sites in
Idelalisib is an investigational, targeted, highly selective oral inhibitor of phosphoinositide 3-kinase (PI3K) delta, a molecular target that is critical for the activation, proliferation and survival of B lymphocytes. PI3K delta signaling is hyperactive in many B-cell leukemias and lymphomas and drives proliferation, survival and trafficking to lymphoid tissue. Idelalisib is being developed both as a single agent and in combination with approved and investigational therapies.
Gilead’s clinical development program for idelalisib includes three Phase 3 studies evaluating the drug in combination with approved therapies for patients with previously treated chronic lymphocytic leukemia (CLL) and two Phase 3 studies of idelalisib in combination with approved therapies for patients with previously treated indolent non-Hodgkin’s lymphoma (iNHL). In addition, combination therapy with idelalisib and GS-9973, Gilead’s novel spleen tyrosine kinase (Syk) inhibitor, is being studied 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 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 Indolent Non-Hodgkin’s Lymphoma
Indolent non-Hodgkin’s Lymphoma (iNHL) refers to a group of slow-growing lymphomas that can lead to life-threatening complications such as serious infections and anemia and includes follicular lymphoma, small lymphocytic lymphoma, lymphoplasmacytic lymphoma / Waldenström macroglobulinemia and marginal zone lymphoma. Patients typically experience enlarged lymph nodes, and other organs such as the spleen and liver may also be involved. Patients may develop symptoms such as fever, night sweats, weight loss and fatigue. Most iNHL patients are diagnosed at an advanced stage of disease, which is usually not curable, and median survival from time of initial diagnosis for patients with the most common form of iNHL, follicular lymphoma, is 8 to 10 years. By contrast, the outlook for patients who are unresponsive to rituximab and chemotherapy, such as those included in this study, is less encouraging.
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 enroll
patients in Phase 3 studies and may need to modify or delay these
studies. As a result, idelalisib may never be successfully
commercialized. Further, Gilead may make a strategic decision to
discontinue development of idelalisib 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
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Gilead Sciences, Inc.
Patrick O’Brien, 650-522-1936 (Investors)
Nathan Kaiser, 650-522-1853 (Media)