Long-Term Survival In Patients (Pts) With Locally Advanced Or Disseminated Malignant Melanoma (Mm) Or Renal Cell Carcinoma (Rcc), Treated With Tag-7 Gene-Modified (Gmv) Tumor Cells: A Phase Ii Trial.

e14022 Background: Immunotherapy may produce long lasting effects on survival.Magnitude of efficacy may be depended from immune factors. We evaluated the overall survival (OS) in pts treated with GMV with biomarker analysis of immunosuppressive factors (ISF) production by their tumor cells. Methods: Since 2001 to 2014 80 pts received GMV: 68 with MM and 12 pts with RCC. Treatment was given in the metastatic setting in 61 pts (MM-51, RCC – 10) and in the adjuvant (after complete cytoreduction) setting in 19 pts (MM-17, RCC-2). Stage 3 was in 26 (33%) pts, stage 4 in 54 (67%). Pt’s tumor samples were transferred to culture, transfected with TAG7and inactivated by radiation. Produced product was injected SC every 3 weeks until progression or 2y of therapy. ISF (MICA, TGF-β1, IL-10 and VEGF) were measured in the supernatants of the tumor cell cultures and used as predictive factors. Results: The 5-yr OS in intention to treat population was 25.1%. There was no differences in MM and RCC OS (Log-rank p = 0.44). Median OS in metastatic setting was 0,7 y, in adjuvant – 3,1 y. Classification trees were built on the basis of ISF production. The median OS was 6.6 y in favorable prognosis (FP) group (MICA level ≤582 pg/ml, n = 15), 4.6 mo in unfavorable (UF) group (MICA level > 582 pg/ml, n = 12) (p < 0.0001). No significant differences were found between classification trees based on the other ISF (TGF-β1, IL-10 and VEGF). In stage 3-4 MM pts with FP median OS was 2,3 y with 31% pts alive in 10y, in UF group – 0,4 y; log-rank p = 1,94E-5. No FP pts received modern immunotherapy. Conclusions: GMV shows high results in carefully selected pts with low ISF production. Method should be further investigated in pts with FP. [Table: see text]