Currently, Pembrolizumab is approved for the management of PD-L1 positive but not PD-L1 negative metastatic cervical cancer. So we hypothesized in this study that we could increase the response rate to single-agent immune checkpoint inhibition in metastatic cervical cancer by combining hypofractionated radiation therapies, stereotactic body radiation treatment with atezolizumab...
Currently, Pembrolizumab is approved for the management of PD-L1 positive but not PD-L1 negative metastatic cervical cancer. So we hypothesized in this study that we could increase the response rate to single-agent immune checkpoint inhibition in metastatic cervical cancer by combining hypofractionated radiation therapies, stereotactic body radiation treatment with atezolizumab. So the study was designed as a phase two multi-institutional study where patients received SBRT to at least one site of metastatic disease. And then following that, a week later, patients would begin atezolizumab at a dose of 1200 milligrams IV Q3 weeks. Patients would continue that regimen until there was confirmed progression or safety issues. So the primary objective of that study was to look at the objective response rate at the unirradiated lesion. The secondary objectives were looking at overall response, progression-free survival, local control at the irradiated lesion, as well as safety. So the study enrolled 21 patients. It closed early after we met our endpoint of objective response rate at the unirradiated target lesion. Ultimately, the objective response rate was 38%. The majority of patients we enrolled in the study had adenocarcinoma and were PD-L1 negative. 71% of the patients that we enrolled were PD-L1 negative. We also noted that there was an overall response in five patients with stable disease noted in 12 patients who enrolled in the study. We noted that there were both objective and overall responses in the PD-L1 negative population and study therapy was well tolerated. So the conclusions that we drew from the study were that the combination of atezolizumab with SBRT is well tolerated and potentially can increase the response rate to single agent immunotherapy, particularly in PD-L1 negative patients where single agent immunotherapy is not approved.
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