The combination of two novel immune therapy agents could be an effective new treatment option for women facing recurrent or advanced cervical cancer, according to the results of a multicenter phase II clinical trial led by researchers at the OSUCCC – James. The study presents the largest trial conducted to date testing the combination of a PD-1 inhibitor (balstilimab) with a CTLA-4 inhibitor (zalifrelimab) in women with recurrent/metastatic cervical cancer. Researchers report an overall response rate of 26% (all study patients), including 8% of patients who experienced complete response and a 32.8% response rate in patients whose tumors were PD-L1+ — a doubling of the expected response rates. “Thanks to screening, most cervical cancers are detected in early or pre-cancerous stages that are very treatable. For women with an advanced or recurrent cancer, however, there are still limited medical therapies that provide durable cancer control. This data suggests the combination of balstilimab and zalifrelimab is an effective and durable new option for treating advanced or recurrent cervical cancers — particularly in patients whose tumors express PD-L1,” says David O’Malley, MD, corresponding author and a gynecologic oncologist at the OSUCCC – James. O’Malley notes that while treatment benefits were most pronounced in patients whose tumors expressed a specific cellular marker known as PD-L1+ (programmed death ligand-1), significant treatment response was seen with this drug combination regardless of PD-L1 status. The team reports its findings in the Dec. 21, 2021, online edition of the Journal of Clinical Oncology. Cervical cancer is the most common gynecologic cancer and the fourth-leading cause of cancer death worldwide. There is currently only one approved immunotherapy treatment option approved for patients with recurrent or metastatic disease.