Zimberelimab is a novel, fully human anti-PD-1 monoclonal antibody with high affinity and selectivity for PD-1.The objective of this study (NCT03972722) was to evaluate zimberelimab, a novel, anti-programmed cell death protein 1 monoclonal antibody, in patients with programmed death ligand-1-positive recurrent or metastatic cervical cancer that had progressed after first- or subsequent-lineplatinum containing standard chemotherapy.
In this single-arm, phase II study, eligible patients in 27 Chinese sites were assigned to receive intravenous zimberelimab 240 mg as monotherapy every 2 weeks until confirmed disease progression, death, intolerable adverse effects, or withdrawal from the study. The primary endpoint was the objective response rate (ORR) assessed per Response Evaluation Criteria in Solid Tumors (version 1.1) by an independent review committee. Secondary endpoints included duration of response (DoR), disease control rate (DCR), progression-free survival(PFS), overall survival (OS), and safety.
Ninety participants were included in the full analysis set, with a median follow-up of 11.5 months. Complete and partial responses were achieved by 4 and 21 patients, respectively, corresponding to an ORR of 27.8% (95% confidence interval [CI], 18.85 to 38.22; P < .0001 vs historical controls). Median OS and DoR were not reached during the study: 12-month OS rates were 54% (95% CI, 41 to 66) and 6-month DoR rates were 84% (95% CI, 58 to 95). Median PFS was 3.7 months and the 12-month PFS rate was 15% (95% CI, 2 to 42). Treatment-related adverse events (TRAEs) occurred in 78.1% of participants, with hypothyroidism (25.7%) and anemia (19.0%) being the most frequently reported. Grade ≥ 3 TRAEs occurred in 22.9% of participants.
Zimberelimab monotherapy demonstrated durable antitumor activity and an acceptable safety profile in patients with recurrent or metastatic cervical cancer that had progressed after first- or subsequent-line platinum-containing standard chemotherapy. Further investigation of zimberelimab in patients with cervical cancer is warranted.
NCT03972722.
The authors.
Guangzhou Gloria Biosciences Co., Ltd.
J. Zhu: Financial Interests, Personal, Member of the Board of Directors: Guangzhou Gloria Biosciences Co., Ltd. All other authors have declared no conflicts of interest.