About the C-800 Trial of Botensilimab/Balstilimab in Ovarian Cancer

Bruno Bockorny, MD, a an attending physician for medical oncology/hematology at Beth Israel Deaconess Medical Center, an assistant professor of medicine at Harvard Medical School, and researcher of Cellular Biology at Beth Israel Deaconess Medical Center, discusses the phase 1 C-800 trial of botensilimab (AGEN1181) plus bastilimab (AGEN2034), specifically for patients in the C-800-01 cohort with recurrent platinum refractory/resistant ovarian cancer (NCT03860272).

The trial enrolled patients with platinum-resistant or refractory, metastatic disease and administered them 1 mg/kg (29%) or 2 (71%) mg/kg of botensilimab every 6 weeks plus 3 mg/kg of balstilimab every 2 weeks.

Patients must have had measurable disease on imaging based on RECIST 1.1, a life expectancy of ≥ 3 months, an ECOG performance status of 0-1, adequate hematological, liver, and renal function, and have n history of prior or concomitant malignancy that requires other active treatment. Additionally, patients were allowed to have received prior immunotherapy, and crossover from prior botensilimab monotherapy was allowed.

Primary end points of the trial were incidence of treatment-emergent adverse events, dose-limiting toxicities of botensilimab, and to determine the recommended phase 2 dose of botensilimab. Secondary end points assessed in the trial included objective response rate, duration of response, disease control rate, progression-free survival, overall survival, and pharmacokinetics.

Transcription:

0:08 | The C-800 trial is a phase 1b clinical trial. It's a very large study that enrolled patients with any solid tumors with disease progression after standard-of-care treatment options including, investigational options and immunotherapy options. This study started with a monotherapy phase with botensilimab at a lower dose, followed by that combination with balstilimab. Now, we are in the final phases with disease specific expansion cohorts.

0:53 | At [the Society of Gynecologic Oncology [SGO] 2023 Annual Meeting on Women’s Cancer] this year, we presented data of patients with ovarian cancer who were platinum resistant or refractory.

REFERENCE:

Fc-engineered anti-CTLA-4 monoclonal antibody in advanced cancer. ClinicalTrials.gov. Updated April 28, 2023. Accessed May 17, 2023. https://clinicaltrials.gov/ct2/show/NCT03860272