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Gilead Sciences, Inc. (NASDAQ: GILD) today announced that 10 abstracts describing the company's investigational agents for several hematological malignancies have been selected for presentation at the Annual Meeting of the American Society of Hematology (ASH) taking place December 7-10 in New Orleans. The abstracts describe clinical and pre-clinical data from studies of idelalisib, which is currently under review by the U.S. Food and Drug Administration for treatment of refractory indolent non-Hodgkin’s lymphoma (iNHL), as well as for GS-9973, GS-9820 and momelotinib (formerly CYT387 / GS-0387). Detailed results from these studies will be presented at the conference.
“We are encouraged by the data across our hematologic oncology pipeline that will be presented at the ASH annual meeting,” said Roy Baynes, MD, PhD, Senior Vice President of Oncology and Inflammation Therapeutics at Gilead Sciences. “We are moving forward quickly to fully explore the potential clinical benefit of idelalisib and other investigational agents against a range of hematological cancers.”
Presentations on idelalisib, Gilead's investigational, targeted, oral inhibitor of PI3K delta include:
Updated data from a Phase 2 study (Study 101-09) in patients with highly refractory iNHL (#85). The results of this trial support Gilead’s regulatory filings for idelalisib for the treatment of iNHL.
Analyses from a Phase 1b study (Study 101-07) of idelalisib in combination with currently approved therapies for the treatment of relapsed/refractory chronic lymphocytic leukemia (CLL) (#4180, #4176 and #2878).
An analysis from Phase 1b and 2 studies (Studies 101-07 and 101-08) comparing responses among CLL patients with high risk prognostic markers (Del(17p)/TP53 mutation, Del(11q), IgHV mutation and NOTCH1 mutation) to CLL patients without these markers (#1632).
The first pre-clinical data demonstrating the potential of idelalisib for the treatment of myelofibrosis (#4065).
Clinical data on other oral investigational compounds in development for the treatment of hematologic malignancies also will be presented, including:
Momelotinib, a selective inhibitor of JAK1 and JAK2: Updated safety and efficacy results from a Phase 1/2 study in myelofibrosis (#108). The Phase 3 clinical program for momelotinib will be initiated this quarter.
GS-9973, a selective inhibitor of spleen tyrosine kinase (Syk): Initial results from a Phase 2 study in CLL and non-Hodgkin lymphoma (NHL) (#1634). GS-9973 is being evaluated in Phase 2 studies as both a single agent (Study 102) and in combination with idelalisib (Study 103) in patients with relapsed or refractory CLL, iNHL and other lymphoid malignancies.
GS-9820, a second-generation inhibitor of PI3K delta: Data from a Phase 1b dose escalation monotherapy study for recurrent CLL or iNHL (#2881).
Abstracts for Gilead's presentations can be accessed at
http://www.hematology.org/Meetings/Annual-Meeting/. Further information about the clinical studies described above can be found at
Idelalisib, momelotinib, GS-9973 and GS-9820, each as single-agents and in combination with other agents, are investigational products, and their safety and efficacy have not been established.