Gilead Shows Long-Term Safety, Disease Control In Zydelig For Lymphomas
By Cyndi Root
Gilead Sciences reports that Zydelig (idelalisib) offers long-term benefits for lymphoma patients. The company announced the findings in a press release, stating that it was presenting the data at the annual Meeting of the American Society of Hematology (ASH). The company characterized the agent’s duration of response, progression-free survival (PFS), and the safety profile in relapsed patients with chronic lymphocytic leukemia (CLL) and indolent non-Hodgkin lymphoma (iNHL).
Norbert Bischofberger, PhD, EVP of R&D and the CSO at Gilead, said, “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.”
Zydelig
Zydelig is phosphoinositide 3-kinase (PI3K) delta inhibitor. The oral agent inhibits the PI3K protein, active in leukemias and lymphomas. Zydelig blocks signaling pathways, affecting the activation and proliferation of cancer cells. The Food and Drug Administration (FDA) approved the agent as a monotherapy in July 2014 for relapsed follicular B-cell non-Hodgkin lymphoma (FL) and small lymphocytic lymphoma (SLL) patients, and the EU approved it in September 2014 for monotherapy in FL patients. Gilead is currently studying the agent in six Phase 3 clinical trials. One study is currently recruiting Japanese patients. Another is testing Zydelig in combination with bendamustine and rituximab for previously treated indolent Non-Hodgkin lymphomas.
Study 101-09 in iNHL
Gilead is reporting on Study 101-09, a Phase 2 study of 125 patients with previously treated iNHL that is refractory both to rituximab and to alkylating-agent-containing chemotherapy. Gilead found that 58 percent of patients responded to Zydelig therapy, including 10 percent who achieved a complete response. Gilead submitted a New Drug Application (NDA) for Zydelig in iNHL patients in September 2013 with supporting data from Study 101-09.
Study 116/117
In study 116, Gilead evaluated Zydelig plus rituximab compared to rituximab alone in relapsed CLL patients intolerant to standard chemotherapy. Study 117 was for patients electing to continue receiving idelalisib therapy. The 110 patients from Study 116/117 who received idelalisib plus rituximab achieved a median progression-free survival (PFS) of 19.4 months.