Galera Therapeutics' Avasopasem Reduces Chemo-Related Kidney Disease By 50% Versus Placebo At One-Year

Galera Therapeutics Inc GRTX announced the presentation of one-year tumor and renal function outcomes data from its Phase 3 ROMAN trial of avasopasem manganese 90 mg for radiotherapy-induced severe oral mucositis (SOM).
After a one-year follow-up, patients with locally advanced head and neck cancer treated with avasopasem in combination with the standard-of-care regimen (intensity-modulated radiation therapy (IMRT) + cisplatin) demonstrated comparable tumor outcomes and overall survival to patients in the placebo arm.
Cisplatin-related chronic kidney disease reduced by 50% in avasopasem patients compared to placebo at one year.
Related: Galera Posts Topline Data From Avasopasem Study In Chemoradiotherapy-Induced Esophagitis.
Patients treated with avasopasem in combination with IMRT + cisplatin had a 10% incidence of chronic kidney disease (CKD) after one year of post-treatment follow-up, compared to 20% of patients in the placebo arm.
CKD is a known toxicity risk with cisplatin for these patients, and the results highlight success on a predefined exploratory endpoint of renal function.
In addition to the ROMAN long-term endpoints, a meta-analysis of Galera's two randomized placebo-controlled trials (ROMAN and GT-201; n=551) was included in the ASTRO presentation.
These results reinforced that avasopasem therapy resulted in clinically meaningful reductions in radiotherapy-induced SOM, including a significant reduction in the incidence, duration, onset, and severity of SOM compared to placebo.
The company said it remains on track to submit NDA to the FDA for avasopasem for radiotherapy-induced severe oral mucositis by the end of 2022.
Price Action: GRTX shares are down 6.74% at $1.66 on the last check Wednesday.

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