Efficacy and Safety of the Anti–PD-L1 mAb Socazolimab for Recurrent or Metastatic Cervical Cancer: a Phase I Dose-Escalation and Expansion Study

Abstract

Purpose: This study (ClinicalTrials.gov identifier, NCT03676959) is an open, phase I dose-escalation and expansion study investigating the safety and efficacy of the recombinant, fully human anti-programmed death-ligand 1 (PD-L1) monoclonal antibody Socazolimab in patients diagnosed with recurrent or metastatic cervical cancer. Experimental Design: 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. The primary endpoints of the dose-expansion phase were safety and the objective response rate (ORR) of the 5mg/kg dose. Efficacy was assessed by the third-party independent review committee (IRC) using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Results: One hundred four patients were successfully enrolled into the study. Twelve patients were included in the dose-escalation phase, with one complete response and two partial responses in the 5mg/kg treatment group. Ninety-two patients (5mg/kg) were enrolled in the dose-expansion phase. Fifty-four patients (59.3%) had baseline PD-L1-positive tumor expression (combined positive score, CPS≥1). 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). ORR of PD-L1-positive patients was 16.7%, and the ORR of PD-L1-negative patients was 17.9%. No treatment-related deaths occurred. Conclusions: Our study demonstrates that Socazolimab has durable 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.

Immune checkpoint blockade for locally advanced or recurrent/metastatic cervical cancer: An update on clinical data

“…Only 7.7% of patients had grade 3–4 TRAEs. These findings demonstrated the safety and efficacy of single-agent Socazolimab for R/M CC treatment ( 43 , 44 ).…”

“…Only 7.7% of patients had grade 3-4 TRAEs. These findings demonstrated the safety and efficacy of single-agent Socazolimab for R/M CC treatment(43,44).Cadonilimab is a PD-1/CTLA-4 bi-specific antibody. A multi-center, open-label, single-arm phase II study from China enrolled 111 patients with R/M CC who had previously received up to two lines of doublet chemotherapy with or without Bevacizumab [a humanized IgG1 anti-vascular endothelial growth factor (VEGF) mAb].…”

“…Patients with CPS ≥1 were subsequently included in the KEYNOTE-826 trial and used as an indication for Pembrolizumab by the NCCN guidelines. However, the NCT03676959 trial did not observe a difference in treatment efficacy between the PD-L1 positive and negative groups (43,44). Whether PD-L1 expression levels can be used as a marker remains controversial and varies widely across tumor types.…”

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“…The overall response rates for PD-L1-positive and PD-L1-negative patients were 16.7% and 17.9%, respectively. 70 …”

Immunotherapy in cervical cancer: From the view of scientometric analysis and clinical trials

“…However, we still lack the support of a large number of multicentered, randomized, controlled phase III clinical trials. (90) ITT, intend to treat; HR, hazard ratio.…”