COLUMBUS, Ohio - Preliminary results from two independent, phase II clinical trials investigating a new PD-1 (programmed cell death protein 1)-based immune therapy for metastatic cervical cancer suggest potential new treatment options for a disease that currently has limited effective options and disproportionately impacts younger women.
David O'Malley, MD, of The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC - James), presented the preliminary study results at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 on Sept. 18. O'Malley was the lead presenter for both trials, which were sponsored by Agenus Inc.
Each study involved more than 150 patients with recurrent or metastatic cervical cancer from cancer treatment centers across the United States and Europe. All patients were previously treated with platinum-based chemotherapy as a first-line therapy. The two independent but consecutive phase II trials tested a new immune-based agent called balstilimab given alone or in combination with a second monoclonal antibody drug called zalifrelimab.
Balstilimab is part of a class of drugs called checkpoint inhibitors. These drugs target the PD-1 protein within cancer cells and act as an "on" switch to help the immune system recognize and destroy cancer cells that would otherwise go undetected. Zalifrelimab is a drug that delivers engineered molecules (monoclonal antibodies) that allow for improved immune response to attack cancer cells.
For the first study, 160 patients were treated with single-agent balstilimab, resulting in a 14% response rate in all treated patients and a 19% response rate in PD-L1 positive patients.
For the second study, 155 patients were treated with balstilimab given in combination with zalifrelimab, resulting in a 22% response rate in all patients and a 27% response rate in PD-L1 positive patients.
"These two studies represent the largest trials of immuno-oncology therapies in relapsed cervical cancer to date and show that balstilimab and zalifrelimab may present meaningful new therapies for patients with cervical cancer," O'Malley says. "Advances in these agents offer renewed hope for patients who have limited treatment options. This is especially important because this disease disproportionately affects younger women."
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O'Malley is a gynecologic oncologist at the OSUCCC - James and professor at The Ohio State University College of Medicine. O'Malley is a compensated consultant for Agenus, sponsor of the studies.
To learn more about gynecologic research and patient care at the OSUCCC - James, visit
About the OSUCCC - James
The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solove Research Institute strives to create a cancer-free world by integrating scientific research with excellence in education and patient-centered care, a strategy that leads to better methods of prevention, detection and treatment. Ohio State is one of only 51 National Cancer Institute (NCI)-designated Comprehensive Cancer Centers and one of only a few centers funded by the NCI to conduct both phase I and phase II clinical trials on novel anticancer drugs sponsored by the NCI. As the cancer program's 356-bed adult patient-care component, The James is one of the top cancer hospitals in the nation as ranked by U.S. News & World Report and has achieved Magnet® designation, the highest honor an organization can receive for quality patient care and professional nursing practice. With 21 floors and more than 1.1 million square feet, The James is a transformational facility that fosters collaboration and integration of cancer research and clinical cancer care.