Efficacy and safety of Genolimzumab in previously treated PD-L1-Positive recurrent or metastatic cervical cancer: a multicenter open-label, single-arm, phase Ⅱ study

Abstract Purpose This phase II trial investigated the efficacy and safety of Genolimzumab (GB226) in patients with previously treated, PD-L1-Positive recurrent or metastatic cervical cancer. Methods We conducted a two-stage, phase II trial to enrol patients who had disease progression after first-line platinum-containing chemotherapy. Genolimzumab was given intravenously at a dose of 3 mg/kg every two weeks until disease progression, unacceptable toxic effects, or withdrawal from the study. The primary endpoint was Independent Review Committee (IRC)-assessed confirmed objective response rate per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Other endpoints included duration of response (DOR), disease control rate (DCR), time to response(TTR), overall survival (OS) and progression-free survival (PFS) and safety. Results 169 patients were enrolled from May 2019 to Jan 2022. In 100 efficacy-evaluable patients, the ORR was 18% (95% CI, 11.03 to 26.95); the disease control rate was 41% (95% CI, 31.26 to 51.29). The median PFS was 1.91 months (95% CI, 1.87 to 3.55 months). The median overall survival was 16.69 months (95% CI, 11.07 to NR months). Furthermore, for 123 safety-evaluable patients, 97(78.9%) patients experienced a treatment-related adverse event. The most frequent treatment-related adverse events were hypothyroidism (30[24.4%]), anaemia (26 [21.1%]) and hyperthyroidism (17 [13.8%]). Conclusions Genolimzumab as a second-line or later therapy has Promising, durable clinical activity and favourable tolerability for patients with, PD-L1-Positive, ECOG=1, Squamous cell carcinoma, one prior line of therapy, no prior bevacizumab therapy or CPS ≥ 20 recurrent or recurrent or metastatic cervical cancer.