RESULTS
death (ligand)-1.Antitumor
DISEASE PROGRESSION, KETOACIDOSIS, RECURRENCE, BEST, DISEASE, METASTASES
Between October 14, 2020, and December 23, 2021, 71 patients were assessed for eligibility, of whom 58 patients were enrolled and received at least one dose of the study regimen (ITT and safety set; Fig Trial profile. PD-(L)1, programmed cell death (ligand)-1.Antitumor activity. The patients in the efficacy-evaluable population were included (n = 52). (A) Best percentage change from baseline in the target lesion. The dashed line at −30% change represents the RECIST version 1.1 cutoff to define PR or CR. (B) Treatment exposure and response duration. Twenty-five patients (43.1%) had locoregional recurrence only, 18 (31.0%) had distant metastases only, and 15 patients (25.9%) had both locoregional recurrence and metastases. All patients received at least one line of prior systemic therapy, with 10 (17.2%) receiving ≥ 2 lines. The baseline characteristics of the population are summarized in Table Baseline Demographics and Disease CharacteristicsAs of the data cutoff (June 2, 2022), the median follow-up was 12.4 months (range, 2.1-19.9 months). Twenty-nine patients (48.3%) discontinued the study treatment, with 26 developing disease progression and three experiencing unacceptable AEs (two refusals and one ketoacidosis). Two patients with disease progression rechallenged the study regimen (Data Supplement).