ASH 2013: Idelalisib Shows Strong Response in Indolent Lymphoma


Gilead Sciences has announced results of the company's Phase II study of its investigational compound idelalisib, an oral inhibitor of PI3K delta for patients with indolent non-Hodgkin's lymphoma refractory to rituximab and to alkylating-agent-containing chemotherapy.

This information was presented at the 55th Annual Meeting of the American Society of Hematology (ASH) in New Orleans (Abstract #85).

A 'valuable' treatment option

As a single agent, idelalisib achieved an overall response rate of 57 percent in these patients with a median duration of response of 12.5 months.

Idelalisib is a highly selective oral inhibitor of phosphoinositide 3-kinase (PI3K) delta. PI3K delta signaling is crucial in the proliferation and survival of B lymphocytes.

Said Ajay Gopal, M.D., Associate Professor, University of Washington School of Medicine and Associate Member, Clinical Research Division, Fred Hutchinson Cancer Research Center in Seattle:

It has been more than ten years since a treatment with a novel mechanism of action has been approved for indolent NHL, underscoring the medical need for new treatments for patients who are no longer responsive to currently available therapies. The overall response rate and durability of response observed in this study suggest that idelalisib may become a valuable new therapy for iNHL patients who have very limited treatment options.

Breakthrough treatment

For the study, they enrolled 125 patients with a median age of 64. Confirmed diagnoses included follicular lymphoma (n=72), small lymphocytic lymphoma (n=28), llymphblastic lymphoma/Waldenstrom macroglobulinemia (n=10) and marginal zone lymphoma (n=15). Patients had received a median of four prior treatment regimens, with 79 percent having refractory disease to two or more prior regimens and 90 percent refractory to their most recent regimen.

Gilead submitted a New Drug Application to the Food and Drug Administration for idelalisib in September for the treatment of refractory indolent NHL, and were granted Breakthrough Therapy designation for the compound against chronic lymphocytic leukemia (CLL) in relapsed patients.

Source: Marketwatch

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