UNASSIGNED: 64 Background: In @entity19 , @entity5 cryo plus immunologic checkpoint blockade generates @entity5 antigen release, proliferation of @entity5 -specific T-cells, and enhanced survival. We previously demonstrated in a pilot study that pre-op cryo+ipi is well tolerated in @entity1 with @entity0 and did not delay standard of care surgical resection. Here, we analyze pilot study tissue and blood to explore immune response. METHODS: 18 @entity0 @entity1 (pts) were treated with preop cryo (n=6), single-dose ipi 10mg/kg (n=6), or cryo+ipi (n=6). As a potential surrogate for @entity5 immunogenicity, baseline T-cell @entity5 infiltrating lymphocyte (TIL) density was evaluated by T-cell receptor quantitative DNA sequencing. We explored the systemic immune response to cryo and/or ipi using previously described laboratory measures including @entity12448 ( @entity12448 , a marker of activated CD4+ T-cells) and plasma @entity379 (IFNy, a cytokine associated with T-cell activity). RESULTS: Of the 18 study pts, 13 pts had @entity66 , 2 pts had @entity1722 + disease (both treated with ipi alone) and 3 pts had @entity549 (1 ipi alone and 2 cryo/ipi). Baseline TIL density was highly variable overall (range 2-30%), but higher in @entity1722 + and @entity549 pts (median 15%) compared with HR+ pts (median 5%). Sustained >2-fold elevations in @entity12448 and IFNy were observed in the majority of cryo+ipi pts 30 days following treatment ( @entity12448 : 5/6 pts; IFNy: 4/6 pts), but in the minority of ipi pts ( @entity12448 : 2/6 pts; IFNy: 2/6 pts) or cryo pts ( @entity12448 : 0/6 pts; IFNy: 0/6 pts). Sustained @entity12448 and IFNy elevations were observed regardless of baseline TIL density. CONCLUSIONS: Cryo+ipi was more likely to induce systemic immune activation compared to cryo or ipi alone. These potentially beneficial immune effects were observed in both HR+ and HR- subtypes, as well as in @entity5 with low or high baseline TIL density. These data support further studies of cryo+ipi in @entity0 across HR+ and HR- subtypes, as well as in @entity5 that do not appear immunogenic at baseline.

@entity5 and systemic immune responses to preoperative (pre-op) cryoablation (cryo) plus immune therapy with ipilimumab (ipi) in @entity0 ( XXXX ).

@entity1 :: ('9606', 'Species') :: ['women', 'patients'] @entity0 :: ('MESH:D001943', 'Disease') :: ['ESBC'] @entity66 :: ('MESH:D004194', 'Disease') :: ['hormone receptor-positive (HR+) disease'] @entity19 :: ('10090', 'Species') :: ['mice'] @entity5 :: ('MESH:D009369', 'Disease') :: ['tumor', 'tumors'] @entity12448 :: ('29851', 'Gene') :: ['inducible costimulator', 'ICOS'] @entity549 :: ('MESH:D064726', 'Disease') :: ['TN', 'triple-negative (TN) disease'] @entity379 :: ('3458', 'Gene') :: ['interferon gamma'] @entity1722 :: ('2064', 'Gene') :: ['HER2']
@entity0 :: (MESH:D001943,Disease) :: ['ESBC']
