Ohio State University has published a report early this week discussing preliminary results from two independent, phase II clinical trials which aim to investigate a new PD-1 (programmed cell death protein 1) -based immune therapy for metastatic cervical cancer. First results have now suggested new treatment options for the condition, which underlines a new breakthrough as metastatic cervical cancer has currently only limited effective options and effects on average more young women. The results were presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 in September and both trials were sponsored by Agenus Inc.
Both trials were researching the new immune-based agent called balstilimab, which belongs to a group of drugs which are also referred to as checkpoint inhibitors. The drug targets the PD-1 protein within cancer cells and helps the immune system to recognize and destroy cancer cells that might usually be undetected.
Clinical trial setup for advanced cervical cancer
Both clinical trials researching the new immune-based agent called balstilimab recruited over 150 patients from the United States and Europe with recurrent or metastatic cervical cancer. The requirement for participants to enter the trial was previous treatment with platinum-based chemotherapy as first-line therapy. Both trials were testing the immune-based agent alone or in combination with a second monoclonal antibody drug (zalifrelimab). Zalifrelimab is a drug that delivers engineered molecules that enable the immune system to improve the immune response to attack cancer cells.
During the first study, 160 patients were treated with balstilimab and resulted in a 14% response rate in all treated patients, and a 19% response rate in PD-L1 patients. The second study were treated with balstilimab in combination with zalifrelimab and resulted in a 22% response rate in all patients and a 27% response rate in PD-L1 patients.
Both studies are the largest clinical research trials for immuno-oncology therapies in relapsed cervical cancer to this day and show a potentially new and meaningful treatment for patients with cervical cancer who have lived with limited treatment options in the past.
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