The following summary is “Efficacy and Safety of the Anti–PD-L1 mAb Socazolimab for Recurrent or Metastatic Cervical Cancer: a Phase I Dose-Escalation and Expansion Study” published in the December 2022 issue of Oncology by An et al.
Safety and effectiveness of the recombinant, completely human anti-programmed death ligand 1 (PD-L1) mAb socazolimab in patients with recurrent or metastatic cervical cancer is being studied in this open, phase I dose-escalation and expansion research (ClinicalTrials.gov identifier, NCT03676959). Socazolimab was given every 2 weeks until the disease progressed, at which point treatment was discontinued. There were 2 parts to the study: a dose-escalation period and an expansion period.
The dose-escalation phase had safety and tolerability as its key goals. In the dose-expansion phase, 5 mg/kg objective response rate (ORR) and safety were the major measures of success. The independent review committee (IRC) used version 1.1 of the Response Evaluation Criteria in Solid Tumors to determine the treatment’s efficacy (RECIST 1.1). The end result is that 104 people were enrolled in the trial. In the dose-escalation phase, which included 12 patients, 1 patient had a complete response, and 2 had partial responses at 5 mg/kg. In the dose-expansion phase, 92 patients received 5 mg/kg. About 54 patients, or 59.3 %, had tumors that expressed PD-L1 at baseline (combined positive score≥1).
The ORR was 15.5 % (95% CI, 8.7 to 24.5 %). With a median PFS of 4.44 months (95% CI, 2.37-5.75 months) and a median OS of 14.72 months (95% CI, 9.59-NE months), patients might expect a long life expectancy. The overall response rate (ORR) was 16.7% in PD-L1-positive patients and 17.9% in PD-L1-negative patients. No deaths could be directly linked to any of the treatments. The results show that socazolimab is safe and effective for the long-term treatment of recurrent or metastatic cervical cancer, and that its safety profile is consistent with that of other anti-PD-1/PD-L1 mAbs.
