Date: 2014-12-08
Type of information: Presentation of results at a congress
phase: 2
Announcement: presentation of results at the Annual Meeting of the American Society of Hematology (ASH).
Company: Gilead (USA - CA)
Product: Zydelig® (idelalisib)
Action
mechanism: kinase inhibitor/phosphoinositide 3-kinase (PI3K) inhibitor.Zydelig® is an oral inhibitor of phosphoinositide 3-kinase (PI3K) delta, a protein that plays a role in the activation, proliferation and viability of B cells. PI3K delta signaling is active in many B-cell leukemias and lymphomas, and by inhibiting the protein, Zydelig blocks several cellular signaling pathways that drive B-cell viability.
Disease: chronic lymphocytic leukemia (CLL), indolent non-Hodgkin lymphoma (iNHL)
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest
news: * On December 8, 2014, Gilead Sciences announced long-term follow-up results from the registration studies further describing the duration of response, progression-free survival (PFS) and safety profile for Zydelig® (idelalisib) in relapsed patients with chronic lymphocytic leukemia (CLL) and two types of indolent non-Hodgkin lymphoma (iNHL). The findings are being presented at the Annual Meeting of the American Society of Hematology (ASH). “The results presented this week demonstrate the long-term benefit of Zydelig in patient populations that often have limited or no treatment options due to age or lack of response to existing therapies,” said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. “As part of our ongoing effort to further define the safety and efficacy profile of Zydelig, we are continuing to pursue long-term follow-up studies and larger Phase 2 and Phase 3 clinical trials in combination with existing treatment regimens in both relapsed and first-line CLL and iNHL.” Study 101-09 is a single-arm Phase 2 study evaluating idelalisib monotherapy in 125 patients with previously treated iNHL that is refractory both to rituximab and to alkylating-agent-containing chemotherapy, a patient population that has few if any treatment options. At the most recent data analysis cutoff (June 2014), 72 patients (58 percent) had responded to therapy, including 12 (10 percent) who have achieved a complete response—an increase from seven (six percent) complete responses reported initially and which were published earlier this year in The New England Journal of Medicine. The median duration of response for all patients at the most recent data cutoff was 12.5 months. The median duration of response among patients in the FL (n=40) and SLL (n=17) subgroups was 10.8 months and 12.5, respectively. The most common Grade ≥3 adverse events among all patients were diarrhea/colitis (19 percent) and pneumonia (12 percent). Grade ≥3 transaminase elevations occurred in 14 percent of patients. Additional long-term data are being presented from Study 116 of idelalisib in previously treated CLL patients: Study 116 was a randomized, placebo-controlled study evaluating idelalisib plus rituximab versus rituximab alone in 220 patients with relapsed CLL who were not able to tolerate standard chemotherapy. Patients in this study were eligible to continue receiving idelalisib therapy in an open-label extension study (Study 117). Results from the primary and the extension study show that among the 110 patients randomized to receive idelalisib plus rituximab, the median PFS has now been reached, and is 19.4 months. In Study 116/117 the most common Grade ≥3 adverse events in patients receiving idelalisib plus rituximab were diarrhea/colitis (16 percent) and pneumonia (13 percent). Grade ≥3 transaminase elevations occurred in 6 percent of patients.
