The combination of retifanlimab, hypofractionated radiotherapy (HFRT), and bevacizumab has produced “encouraging” survival results in patients with recurrent glioblastoma, according to a presentation at ESMO Congress 2022.
“Our study has shown promising overall response rate, with durable response,” said study presenter Jian Campian, MD, PhD, of the Mayo Clinic in Rochester, Minnesota. “Interim analysis suggests encouraging progression-free survival and overall survival at the time of the data cutoff.”
Dr Campian and colleagues evaluated this combination regimen in cohort A of a phase 2 trial (ClinicalTrials.gov Identifier: NCT03532295). The cohort included 24 patients with IDH1 wild-type, recurrent glioblastoma.
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At baseline, the median age was 64.2 years, and 29% of patients were women. MGMT promoter methylation was present in 29% of patients and indeterminate in 21%. The median Karnofsky performance status was 90, 17% of patients had received prior bevacizumab, and 33.3% had multifocal disease.
Patients received retifanlimab (500 mg IV every 4 weeks), bevacizumab (10mg/kg IV every 2 weeks), and HFRT (3.5 Gy/day in 10 fractions).
The primary endpoint — overall survival (OS) at 9 months — was met. The median OS was 11.1 months, and the 9-month OS rate was 67%.
The median progression-free survival was 7.6 months. The overall response rate was 62.5%, and 37.5% of patients remained in response for more than 6 months. One patient achieved a complete response. The disease control rate was 87.5%.
Two patients experienced grade 3 or higher adverse events, 1 case of myositis and 1 case of hypertension. The most common grade 1-2 adverse events were ALT elevation (21%), TSH elevation (21%), AST elevation (17%), fatigue (13%), and hypothyroidism (13%).
The second cohort of this study, cohort B, is still enrolling. Patients in this cohort will receive epacadostat plus retifanlimab, HFRT, and bevacizumab.
Disclosures: This study was supported by Incyte. Some of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Reference
Campian JL, Butt O, Huang J, et al. Preliminary results of a phase II study of retifanlimab (PD-1 inhibitor) plus or minus epacadostat (IDO1 inhibitor) in combination with bevacizumab and hypofractionated radiotherapy for recurrent glioblastoma: NCT03532295. Presented at ESMO 2022; September 9-13, 2022. Abstract 278O.
