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. 2022 May 5;28(17):3695–3708. doi: 10.1158/1078-0432.CCR-21-4256

Figure 1.

Figure 1. Pharmacodynamic biomarker ICOS-hi CD4 T-cell emergence correlates with response and improvements in OS and PFS. A retrospective analysis was performed on 44 patients who had both evaluable longitudinal PBMC samples and were evaluable for efficacy. In all panels, patients who have ICOS-hi CD4 T-cell emergence at any timepoint are depicted in purple; patients without ICOS-hi CD4 T-cell emergence at any time are depicted in blue. A, Waterfall plot reflecting individual patients’ maximum reduction in the sum of diameters of target tumors compared with baseline in patients with at least one postbaseline CT scan (n = 42). Not all patients with ≥ 30% tumor reductions are RECIST PR. B, Patients with emergence of ICOS-hi CD4 T cells had improved responses, PFS and OS as compared with patients without emergence of this pharmacodynamic biomarker. C, Kaplan–Meier curve demonstrates improved PFS in ICOS-hi versus ICOS-lo patients. D, Kaplan–Meier curve demonstrating the OS benefit for patients with ICOS-hi CD4 T-cell emergence as compared with patients who are ICOS-lo. Data cut for all panels is July 22, 2020. ICOS, inducible costimulator; ICOS-hi, patients with an emergent CD4 T-cell population with high levels of ICOS; ICOS-lo, patients without the emergence of a CD4 T-cell population expressing high levels of ICOS; PFS, progression-free survival; ORR, overall response rate; OS, overall survival; NE, not estimable.

Pharmacodynamic biomarker ICOS-hi CD4 T-cell emergence correlates with response and improvements in OS and PFS. A retrospective analysis was performed on 44 patients who had both evaluable longitudinal PBMC samples and were evaluable for efficacy. In all panels, patients who have ICOS-hi CD4 T-cell emergence at any timepoint are depicted in purple; patients without ICOS-hi CD4 T-cell emergence at any time are depicted in blue. A, Waterfall plot reflecting individual patients’ maximum reduction in the sum of diameters of target tumors compared with baseline in patients with at least one postbaseline CT scan (n = 42). Not all patients with ≥ 30% tumor reductions are RECIST PR. B, Patients with emergence of ICOS-hi CD4 T cells had improved responses, PFS, and OS as compared with patients without emergence of this pharmacodynamic biomarker. C, Kaplan–Meier curve demonstrates improved PFS in ICOS-hi versus ICOS-lo patients. D, Kaplan–Meier curve demonstrating the OS benefit for patients with ICOS-hi CD4 T-cell emergence as compared with patients who are ICOS-lo. Data cutoff for all panels is July 22, 2020. ICOS, inducible costimulator; ICOS-hi, patients with an emergent CD4 T-cell population with high levels of ICOS; ICOS-lo, patients without the emergence of a CD4 T-cell population expressing high levels of ICOS; PFS, progression-free survival; ORR, overall response rate; OS, overall survival; NE, not estimable.