News Release
ZymoGenetics Reports Encouraging Phase 2 Results in Renal Cell Cancer for IL-21 with Nexavar(R)
May 31, 2009
“These results add to the case for efficacy and safety of IL-21 when
used with Nexavar in patients previously treated for renal cell cancer
and point to a meaningful benefit of IL-21 when used in combination with
a targeted therapy,” said
Thirty-three patients were enrolled in the open-label, multi-center
Phase 2 clinical trial conducted at 14 sites in the U.S. and
Patients with metastatic renal cell cancer received 2nd or 3rd line therapy consisting of IL-21 (30 mcg/kg on days 1-5 and 15-19 of each 7-week treatment course) in combination with the approved dose of Nexavar (400 mg PO BID continuously). The majority of adverse events and lab abnormalities were grade 1 or 2. Grade ≥3 adverse events considered possibly related to study drug (IL-21 or Nexavar) and occurring in ≥3 patients included hypophosphatemia (42%), hand-foot syndrome (24%), rash (27%), thrombocytopenia (9%), and neutropenia (9%). Overall, the combination of IL-21 and Nexavar was tolerable in an out patient setting, with some patients staying on treatment for up to a year.
The independent review of tumor response was completed for 33 patients and showed 7 confirmed partial response (21%), 1 unconfirmed partial response (3%), 19 stable disease (58%), and 4 progressive disease (12%) and 2 unevaluable patients, for an overall disease control rate of 82% . Median PFS was 5.7 months or 24.6 weeks. The final Phase 2 results in renal cell cancer indicated that IL-21 combined with Nexavar was well tolerated and is associated with meaningful anti-tumor activity both in terms of tumor response and duration of disease control (i.e. PFS) in patients who have failed prior therapy for advanced renal cell cancer.
About Interleukin 21 (IL-21)
Despite the positive impact of targeted therapies on treatment for renal
cell cancer, the efficacy of these agents appears to decrease beyond the
first-line setting. There is an unmet need for novel therapies after
failure of the targeted agents. IL-21, a cytokine that enhances CD8+ T
cell and NK cell activity, has single-agent anti-tumor activity (J
Clin Oncol 26:2034, 2008).
About
This press release contains "forward-looking statements" within the
meaning of the Private Securities Litigation Reform Act of 1995. These
forward-looking statements are based on the current intent and
expectations of the management of
Nexavar® (sorafenib) tablets is a registered trademark of
Source:
ZymoGenetics, Inc.
Susan W. Specht, Director, Corporate
Communications, 206-442-6592
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"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: Statements in this press release regarding ZymoGenetics Inc.'s business which are not historical facts are "forward-looking statements" that involve risks and uncertainties. For a discussion of such risks and uncertainties, which could cause actual results to differ from those contained in the forward-looking statements, see "Risk Factors" in the Company's Annual Report or Form 10-K for the most recently ended fiscal year.