A new treatment approach of toripalimab in combination with concurrent platinum‐based chemoradiotherapy for locally advanced cervical cancer: A phase II clinical trial

Abstract This study investigated the efficacy and safety of toripalimab in combination with concurrent platinum‐based chemoradiation in patients with untreated locally advanced cervical cancer. Eligible patients received toripalimab 240 mg once every 3 weeks in combination with concurrent platinum‐based chemoradiotherapy, followed by the maintenance of toripalimab once every 6 weeks up to 1 year. The primary endpoint was objective response rate (ORR). Secondary endpoints included 2‐year and 3‐year progression‐free survival (PFS) rates, 3‐year overall survival (OS) rate, and safety. Biomarker analysis of PD‐L1 expression and genomic mutational analysis by next‐generation sequencing were conducted, as well as PD‐L1 expression on tumor biopsies. A total of 82 patients were enrolled. The median follow‐up was 21 months (range, 5.2–44.5 months). The ORR and disease control rate were both 87.8% among the 82 patients. Median PFS and OS were not reached. A trend toward longer PFS was observed in the populations with a PD‐L1 combined positive score ≥10, low tumor mutation burden and loss of heterozygosity in human leukocyte antigen (HLA LOH) detected populations. A total of 37 patients experienced treatment‐related adverse events, of which 17 (20.7%) patients experienced grade 3 or higher adverse events. Collectively, toripalimab plus concurrent platinum‐based chemoradiotherapy showed promising antitumor efficacy with acceptable safety profiles in patients with untreated locally advanced cervical cancer.