Iparomlimab and tuvonralimab in previously treated patients with cervical cancer

Iparomlimab and tuvonralimab (QL1706) is a bifunctional antibody containing anti-programmed death-1 IgG4 and anti-cytotoxic T-lymphocyte antigen 4 IgG1. This multi-center single-arm phase 2 trial recruits patients with recurrent or metastatic cervical cancer (r/m CC) who have failed at least first-line platinum-based chemotherapy with or without bevacizumab. QL1706 is administered at a dose of 5.0 mg/kg every 3 weeks via intravenous infusion. The primary endpoint is objective response rate (ORR) per independent review committee (IRC). In a total of 148 patients, the confirmed ORR and disease control rate are 33.3% (95% confidence interval [CI]: 25.8%-41.6%) and 65.3% (95% CI: 57.0%-73.0%) per IRC, respectively. The median progression-free survival is 5.4 months (95% CI: 3.9-6.9). The median overall survival is 17.1 months (95% CI: 14.8 to not evaluable). Treatment-related adverse events occur in 107 (72.3%) patients. No treatment-related death occurs. QL1706 shows promising efficacy and is well tolerated in previously treated patients with r/m CC. The trial is registered at clinicaltrials.gov (NCT05557565).