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Compared with the chemotherapy group, the OS (HR = 0.70; P < 0.01) and PFS (HR = 0.62; P < 0.01) were significantly longer and the objective response rate (OR = 2.07; P < 0.01) was significantly higher in the PD-1 inhibitor plus chemotherapy group. An OS benefit was observed in patients regardless of histology or programmed cell death 1 ligand 1 combined positive score.
In safety analyses, PD-1 inhibitor plus chemotherapy had a significantly higher incidence of TRAEs (OR = 1.85; P < 0.01), but there was no significant difference in grade 3 or higher TRAEs (OR = 1.24; P = 0.05).
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