Galera Therapeutics, Inc. presented data from the Phase 3 ROMAN trial demonstrating avasopasem manganese (avasopasem) improved preservation of kidney function and reduced cisplatin-related chronic kidney disease (CKD) in patients with head and neck cancer (HNC) at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting. Patients in the ROMAN trial received standard-of-care radiation therapy with concurrent cisplatin. These kidney results are in addition to the ROMAN data showing a significant reduction in severe oral mucositis (SOM) in these patients, which form the basis of the avasopasem New Drug Application (NDA) currently under priority review with the U.S. Food and Drug Administration (FDA).

Highlights from the Phase 3 ROMAN data presented at ASCO: Avasopasem was associated with significant improvements in preservation of kidney function compared to placebo based on mean change in estimated Glomerular Filtration Rate (eGFR) compared to baseline, beginning by 3 months through the one-year end of follow-up Avasopasem was associated with a significant reduction in incidence of grade 3+ CKD according to KDIGO1 criteria (eGFR <60 mL/min/1.73m2) 10% of patients treated with avasopasem had grade 3+ CKD, compared to 20% of patients in the placebo arm at one-year follow-up (relative risk 0.55, p=0.0043) Reductions in CKD were consistent across cisplatin dosing schedules Avasopasem was associated with reduced incidence of cisplatin-related renal adverse events during treatment This prospectively-defined exploratory analysis of the Phase 3 ROMAN trial included patients undergoing the standard-of-care regimen of intensity-modulated radiation therapy (IMRT) with concurrent cisplatin. The effect of avasopasem on kidney function was assessed throughout treatment and every three months for one year following seven weeks of therapy. Grade 3+ CKD was defined as eGFR <60 mL/min/1.73m2.