A phase II clinical trial of toripalimab in advanced solid tumors with polymerase epsilon ...
From April 2019 to August 2023, 15 patients with various cancers and confirmed germline or somatic POL-MUTs were enrolled. Median age was 50 years, with most diagnosed at stage IV and having undergone multiple prior treatments. Most (66.7%) had POLE mutation. Response to toripalimab was evaluated in 14 patients, showing an objective response rate of 21.4% and disease control rate of 57.1%. Three patients had complete or partial responses, and two completed two-year protocol treatment. Treatment-related adverse events were reported in 60% of patients, with one death related to treatment. POLE/POLD1 mutation status influenced treatment response, with POLE-EDMs showing better response rates than POLE-non-EDMs. Patients with POLE/POLD1 and PBRM1 co-mutations exhibited higher TMB and immunotherapy response signature scores, suggesting a favorable response to immunotherapy.
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From April 2019 to August 2023, 15 patients with various cancers and confirmed germline or somatic POL-MUTs were enrolled. Median age was 50 years, with most diagnosed at stage IV and having undergone multiple prior treatments. Most (66.7%) had POLE mutation. Response to toripalimab was evaluated in 14 patients, showing an objective response rate of 21.4% and disease control rate of 57.1%. Three patients had complete or partial responses, and two completed two-year protocol treatment. Treatment-related adverse events were reported in 60% of patients, with one death related to treatment. POLE/POLD1 mutation status influenced treatment response, with POLE-EDMs showing better response rates than POLE-non-EDMs. Patients with POLE/POLD1 and PBRM1 co-mutations exhibited higher TMB and immunotherapy response signature scores, suggesting a favorable response to immunotherapy.