Key clinical point: The superoxide dismutase mimetic GC4419 (avasopasem manganese) reduced oral mucositis without affecting tumor control in patients with locally advanced oral cavity or oropharynx cancer.
Major finding: When compared with placebo, the 90-mg dose of GC4419 conferred a 92% reduction in median days of severe oral mucositis (P = .024). At 1 and 2 years, there were no significant differences between the treatment arms with regard to locoregional control, distant metastasis, progression-free survival, or overall survival.
Study details: Phase 2 trial of 223 patients treated with radiotherapy plus cisplatin and randomized to placebo or GC4419 at 30 mg or 90 mg.
Disclosures: The trial was sponsored by Galera Therapeutics. Dr. Anderson is an uncompensated research adviser to the company.
Anderson CM et al. Head and Neck Cancer Symposium. Abstract LBA 2.