David M. O’Malley, MD, Department of Obstetrics and Gynecology at The Ohio State University College of Medicine and the director of the Division of Gynecologic Oncology at the OSUCCC – James speaks about the Niraparib Maintenance Therapy in Platinum-Sensitive, Recurrent Ovarian Cancer.
Link to Abstract:
https://www.gynecologiconcology-online.net/article/S0090-8258(21)01316-0/fulltext
Summary –
Objective:
Balstilimab, an anti-PD-1 antibody, was tested in patients with previously treated, recurrent/metastatic cervical cancer for its safety and anticancer efficacy in this phase II clinical study.
Methods:
Patients who had recurrent and/or metastatic cervical cancer and had relapsed following a previous platinum-based therapy regimen for advanced disease were eligible. Balstilimab was given intravenously once every two weeks at a dose of 3 mg/kg for up to 24 months. An independent review committee examined the primary endpoint, which was the objective response rate (ORR, RECIST v1.1).
Results:
161 women (median age 53 years [range 25–81]) were enrolled and treated with balstilimab at the data cutoff. These patients were included in the effectiveness analysis because they had the detectable disease at baseline and had had one prior line of platinum-based treatment in the metastatic, persistent, or recurrent context. The ORR was 15% (95 percent confidence interval: 10.0 percent–21.8 percent), with 5 patients receiving a full response and 16 receiving a partial response. The average response time was 15.4 months. Balstilimab had a 20% ORR in patients with PD-L1-positive tumors, but it also had a 20% ORR in individuals with PD-L1-negative tumors (ORR, 7.9 percent ). Responses were not limited to tumors with squamous cell histology, and a subgroup of patients with cervical adenocarcinoma had an ORR of 12.5%. The illness control rate was 49.3% (95 percent confidence interval: 41.1–57.5 percent). The most frequent grade 3 or higher treatment-related adverse events were immune-mediated enterocolitis (3.1%) and diarrhea (1.9%).
Conclusion:
Balstilimab showed substantial and long-lasting therapeutic efficacy in patients with recurrent/metastatic cervical cancer who had previously been treated.