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GC4419 reduces severe oral mucositis in head and neck cancer
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GC4419 significantly reduced severe oral mucositis among patients with head and neck cancer, according to results of a phase 2b trial released by the agent’s manufacturer.
GC4419 (Galera Therapeutics) — a highly selective small molecule dismutase mimetic — is indicated to treat grade 3 or grade 4 oral mucositis, a common side effect for patients with head and neck cancer who undergo chemoradiation.
There is no drug approved to prevent or treat severe oral mucositis for patients with head and neck cancer.
Galera Therapeutics released results of a trial that included 223 patients with head and neck cancer who were scheduled to receive 7 weeks of radiation therapy plus cisplatin.
Researchers randomly assigned patients 1:1:1 to 30 mg GC4416, 90 mg GC4419 or placebo via infusion on the days of their radiation treatment.
Duration of severe oral mucositis served as the primary outcome.
Results showed GC4419 led to a 92% reduction in duration of oral mucositis (P = .024).
GC4419 also appeared associated with:
- a 34% reduction in incidence of severe oral mucositis through completion of radiotherapy (P = .009);
- a 36% reduction in overall incidence of severe oral mucositis through 60 Gy of radiation (P = .01); and
- a 47% reduction in incidence of grade 4 oral mucositis (P = .045).
The drug appeared well tolerated, and frequency of treatment-related side effects was comparable across all treatment arms in the trial.
“Up to 70% of patients with head and neck cancer receiving radiotherapy experience severe oral mucositis, and GC4419 has the potential to become an important treatment in a therapeutic area that has not seen meaningful innovation,” J. Mel Sorensen, MD, president and CEO of Galera Therapeutics, said in a company-issued press release.
“The results of this trial validate the superoxide dismutase mimetic mechanism of action of GC4419, demonstrating its role in reducing the side effects of radiation therapy,” Sorensen added. “We look forward to discussing the results of this trial and our next steps with the FDA.”
The FDA has granted fast track designation to GC4419 for the reduction of oral mucositis among patients with head and neck cancer.