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• W2288007295 abstract "16008 Background: Despite the impact of tyrosine kinase inhibitors on the outcome for mRCC, complete responses are rare and long term survival remains poor. rIL-21, a cytokine that enhances CD8+ T cell and NK cell activity, demonstrated single agent anti-tumor activity in Phase 1 studies. To explore the combined use of rIL-21 with sorafenib in patients with mRCC, a Phase 1/2 dose escalation study was initiated. Results from the Phase 1 dose escalation are reported here. Methods: First or 2nd-line patients received sorafenib at 400 mg BID plus rIL-21 at 1 of 4 dose levels (10, 30, 40, or 50 μg/kg IV) on days 1–5 and 15–19 of a 6-week treatment course. Safety, pharmacokinetics (PK), and tumor response per RECIST were assessed. In Phase 2, 30 patients will receive 2nd or 3rd-line therapy with rIL-21 at the maximum tolerated dose + sorafenib. Results: 14 patients were treated at 3 consecutive dose levels of 10, 30, and 50 μg/kg. After documentation of DLT in 2 subjects at 50 μg/kg, an intermediate dose level cohort at 40 μg/kg was opened. 3 patients have currently been treated at this dose level. Most adverse events (AEs) were Grade 1 or 2, and consistent with the known toxicity of rIL-21 and sorafenib. Treatment-related Grade 3 AEs were hypophosphatemia (n=6), hand-foot syndrome (n=5), rash (n=2), fatigue (n=2), hyponatremia (n=2), elevated liver transaminases (n=2), fever (n=1), and dehydration (n=1). DLTs of diffuse erythroderma with hand-foot syndrome were reported in 1 of 6 patients at 10 μg/kg and 2 of 4 patients at 50 μg/kg. Sorafenib and rIL-21 PK estimates were within the expected range for single agent therapy. To date, 10 patients have been evaluable for tumor response. Per investigator assessment, all 10 had tumor shrinkage at first evaluation, and all received additional courses (2–5). 5 patients had ≥ 30% tumor shrinkage as best response to date, including one confirmed PR at 50 μg/kg. 11 subjects continue on study. Conclusions: rIL-21 plus sorafenib can be administered in the outpatient setting and is associated with anti-tumor activity. Sorafenib PK data suggests that rIL-21 does not increase plasma levels of sorafenib. The Phase 1 results have justified initiation of the Phase 2 portion to confirm the anti-tumor effect of the combination. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration ZymoGenetics, Inc. ZymoGenetics, Inc. ZymoGenetics, Inc. ZymoGenetics, Inc." @default.
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• W2288007295 date "2008-05-20" @default.
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• W2288007295 title "Recombinant IL-21 (rIL-21) in combination with sorafenib: Interim results from a phase 1/2 study in patients with metastatic renal cell cancer (mRCC)" @default.
• W2288007295 doi "https://doi.org/10.1200/jco.2008.26.15_suppl.16008" @default.
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