On June 5, 2023 Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, reported 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) (Free ASCO Whitepaper) Annual Meeting (Press release, Galera Therapeutics, JUN 5, 2023, View Source [SID1234632472]). 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).
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"The demonstrated improvement in kidney function and reductions in cisplatin-related CKD following treatment suggest that avasopasem has the potential to significantly reduce known kidney toxicities associated with cisplatin and other platinum-based chemotherapies," said Mel Sorensen, M.D., Galera’s President and CEO. "In addition to a reduction in reported renal toxicity adverse events during treatment, benefits to kidney function were observed soon after cessation of cisplatin therapy, with CKD reduced by 50 percent in the avasopasem treatment arm at one year, regardless of cisplatin dosing schedule. Our Phase 3 ROMAN trial demonstrated avasopasem’s ability to reduce SOM, a debilitating toxicity induced by radiotherapy, and our NDA for this indication is currently under FDA priority review. The pre-specified exploratory analysis of CKD presented at ASCO (Free ASCO Whitepaper) suggests a potential additional protective clinical benefit for patients undergoing treatment with cisplatin in multiple cancers."
Highlights from the Phase 3 ROMAN data presented at ASCO (Free ASCO Whitepaper):
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.
The presentation is available on Galera’s website at View Source
About Avasopasem
Avasopasem manganese 90 mg (avasopasem, or GC4419) is a selective dismutase mimetic in development for the reduction of radiotherapy-induced severe oral mucositis (SOM) in patients with locally advanced head and neck cancer (HNC) and for the reduction of radiotherapy-induced esophagitis in patients with lung cancer. The FDA has granted Fast Track and Breakthrough Therapy designations to avasopasem for the reduction of SOM induced by radiotherapy. Avasopasem is currently under FDA priority review for radiotherapy-induced SOM in patients with HNC undergoing standard-of-care treatment.