Serplulimab, a novel anti-PD-1 antibody, in patients with microsatellite instability-high solid tumours: an open-label, single-arm, multicentre, phase II trial

• DOI: 10.1038/s41416-022-02001-3
• Publication Date: 2022-10-19T06:03:01Z
• Authors: Shukui Qin; Jin Li; Haijun Zhong; Chuan Jin; Lili Chen; Xianglin Yuan; Qingxia Fan; Kehe Chen; Peiguo Cao; Jianjun Xiao; Da Jiang; Tao Zhang; Hongyu Zhang; Xicheng Wang; Wei Wang; Lin Han; Qingyu Wang; Jun Zhu
• Keywords: Tolerability; Clinical endpoint; Microsatellite Instability

Abstract Background Microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) tumours have a high response rate to immunotherapy. Antitumour activity and safety of serplulimab, novel humanised anti-PD-1 monoclonal antibody, were evaluated in this phase II study. Methods In ongoing, single-arm, open-label, trial, patients with previously treated unresectable or metastatic MSI-H/dMMR solid received intravenous serplulimab 3 mg/kg every 2 weeks for up 52 cycles. The primary endpoint was objective (ORR) assessed by an independent radiological review committee per Response Evaluation Criteria Solid Tumors v1.1. Secondary endpoints included additional efficacy measures, safety, tolerability. Results As 9 January 2021, 108 enrolled, 68 confirmed MSI-H the main analysis population (MEAP). median follow-up duration MEAP 7.7 months, ORR 38.2% (95% confidence interval, 26.7–50.8). Of patients, grade ≥3 treatment-emergent adverse events reported 53 (49.1%) patients; immune-related occurred (48.1%) patients. Conclusions Serplulimab demonstrates durable antitumour effect manageable profile tumours. is promising tissue-agnostic treatment Trial registration NCT03941574.