Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing, China
Jusheng An , Li Guiling , Jie Tang , Benjamin Xiaoyi Li , Hui Hua Xiong , Hui Qiu , Lin Luo , Li Wang , Danbo Wang , Qi Zhou , Qin Xu , Hong Lin Song , Yun Yan Zhang , Hong Ping Zhang , Rachel Ng , Zewei Zhao , Xiang Rong Dai , Yu Jie Li , Yuanjue Sun , Lingying Wu
Background: The study (NCT03676959) is an open-label, phase I study investigating the safety and efficacy of the recombinant, fully human anti-programmed death-ligand 1 (PD-L1) monoclonal antibody socazolimab for recurrent or metastatic cervical cancer. Methods: Patients received socazolimab every 2 weeks until disease progression. The study was divided into a dose-escalation phase and a dose-expansion phase. Safety and tolerability were primary endpoints of the dose-escalation phase. Primary endpoints of the dose-expansion phase were safety and overall response rate (ORR) of the 5mg/kg dose. Efficacy was assessed by a third-party independent review committee (IRC) using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as the evaluation standard. Pharmacokinetics and pharmacodynamics were also studied. Results: One hundred four patients were enrolled. Twelve patients were included in the dose-escalation phase, with one complete and two partial responses in the 5mg/kg treatment group. Ninety-two patients (5mg/kg) were enrolled in the dose-expansion phase, with 54 patients (59.3%) expressing baseline PD-L1-positive tumors. ORR was 15.4% (95% CI, 8.7 to 24.5%). Median PFS was 4.44 months (95% CI, 2.37 to 5.75 months), and the median OS was 14.72 months (95% CI, 9.59 to NE months). ORRs for PD-L1-positive and PD-L1-negative patients were 16.7% and 17.9%, respectively. Treatment-related grade 3 to 4 adverse events occurred in 7.7% of patients. No treatment-related deaths had occurred. Conclusions: Our study demonstrates that socazolimab has remarkable safety and efficacy for the treatment of recurrent or metastatic cervical cancer and exhibits a safety profile similar to other anti–PD-1/PD-L1 monoclonal antibodies. Clinical trial information: NCT03676959.
Efficacy | 5 mg/kg Dose Expansion (N = 91) | CPS < 1 (N = 28) | CPS ≥ 1 (N = 54) | CPS < 10 (N = 52) | CPS ≥ 10 (N = 30) |
---|---|---|---|---|---|
ORR | 14 (15.4%; 8.7%, 24.5%) | 5 (17.9%; 6.1%, 36.9%) | 9 (16.7%; 7.9%, 29.3%) | 8 (15.4%; 6.9%, 28.1%) | 6 (20.0%; 7.7%, 38.6%) |
PFS, months (95% CI) | 4.44 (2.37, 5.75) | 2.79 (1.81, 5.72) | 5.29 (2.56, 10.58) | 3.58 (2.00, 5.78) | 7.56 (2.56, NE) |
12-month PFS | 28.4% (18.2%, 39.5%) | 30.5% (13.8%, 49.2%) | 32.5% (18.5%, 47.2%) | 22.8% (10.7%, 37.7%) | 45.5% (26.2%, 63.0%) |
OS, months (95% CI) | 14.72 (9.59, NE) | 15.84 (7.10, NE) | NE (13.34, NE) | 15.84 (8.54, NE) | NE (13.34, NE) |
12-month OS | 58.2% (45.4%, 69.0%) | 59.3% (36.6%, 76.3%) | 68.3% (51.4%, 80.4%) | 57.2% (39.5%, 71.5%) | 77.0% (55.3%, 89.1%) |
TOR, months (range) | 2.00 (1.64 - 3.65) | 2.43 (1.84 - 3.61) | 1.87 (1.64 - 3.65) | 2.25 (1.74 – 3.65) | 1.77 (1.64 – 2.00) |
Data noted as No. (%; 95% CI) unless stated. Abbreviation: TOR, Time to Response.
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Abstract Disclosures
First Author: Igor Tsaur
2023 ASCO Annual Meeting
First Author: Jianqing Zhu
2023 ASCO Annual Meeting
First Author: Jihong Liu
2023 ASCO Annual Meeting
First Author: Zhongjie Chen