Argos Therapeutics announced results from its Phase 2 study of AGS-003 in combination with sunitinib for the treatment of metastatic renal cell carcinoma (mRCC). Twenty-five patients with newly diagnosed, clear cell mRCC were enrolled in the study, of which 22 received at least one dose of AGS-003. Following nephrectomy, patients initiated standard sunitinib therapy (daily for 4 weeks, followed by 2 weeks off). After a minimum of one sunitinib cycle, patients then received concomitant AGS-003 injections every 3 weeks for up to 5 doses, and every 3 months thereafter until disease progression or end of study. The interim data demonstrated positive median Progression-Free Survival (PFS) results in unfavorable risk, newly diagnosed, metastatic RCC (mRCC) patients. The median PFS was 14.9 months for intermediate risk and 6 months for poor risk mRCC subjects, which compares favorably to historical results with sunitinib alone in unfavorable risk patients.
AGS-003 is an immunotherapy that possesses tumor antigens, including the patient’s unique mutated antigens, in order to produce a possible immune response, limit tumor escape, and induce immunologic memory relevant to each patient.
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