ZymoGenetics presents interim Interleukin 21 phase 2 results in renal cell cancer

ZymoGenetics, Inc. presented interim results today from a Phase 2 clinical trial evaluating Interleukin 21 (IL-21) in combination with Nexavar (sorafenib) tablets in patients with metastatic renal cell cancer.

Outpatient therapy with IL-21 and Nexavar as a second or third-line therapy for metastatic renal cell cancer was associated with anti-tumor activity, with manageable side effects. Of subjects treated and assessed by independent review, 3 of 18 patients had a confirmed partial response, for an overall response rate of 17%. In addition, two partial responses have not yet been confirmed. The overall response rate and disease control rate observed with the combination treatment regimen appears to compare favorably to results obtained in separate studies with single-agent Nexavar. The data was presented at the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics.

"We continue to see promising anti-tumor effects from the combination of IL-21 and Nexavar in patients with renal cell cancer," said Nicole Onetto, M.D., Senior Vice President and Chief Medical Officer of ZymoGenetics. "We look forward to final results, including progression-free survival data, in the first half of 2009."

IL-21 with Nexavar is being tested in the Phase 2 study in an outpatient setting to evaluate the safety, pharmacokinetics and anti-tumor efficacy of the combination using the maximum tolerated IL-21 dose determined in Phase 1 (30 mcg/kg). Study endpoints were overall response rate and progression-free survival. Subjects had previously received one or two targeted therapies for renal cell cancer but had disease progression.

Anti-tumor activity (including 3 confirmed PRs) was observed, with stable disease or partial or complete response at any time on study, in 89% or 16 of 18 patients evaluated by independent and investigator review. Seven (54%) of the 13 patients who completed 3 treatment courses had stable disease or better. Interim results suggest a potential additive effect of IL-21.

Most adverse events (AEs) were Grade 1 or 2 and consistent with the known toxicity of Nexavar and IL-21 when administered as single agents. Serious AEs that were considered possibly related to IL-21 occurred in 6 subjects and included acute renal failure; rash and dehydration; coagulopathy, metabolic acidosis, and neutropenia; dyspnea; and acute hemolytic anemia.

http://www.zymogenetics.com