The dismutase mimetic avasopasem manganese was not found to significantly reduce the incidence of severe oral mucositis in patients with locally advanced head and neck cancer who were receiving standard-of-care radiotherapy, missing the primary end point of the phase 3 ROMAN trial.
The dismutase mimetic avasopasem manganese (GC4419) was not found to significantly reduce the incidence of severe oral mucositis (SOM) in patients with locally advanced head and neck cancer who were receiving standard-of-care (SOC) radiotherapy, missing the primary end point of the phase 3 ROMAN trial (NCT03689712).1
Avasopasem reduced the incidence of SOM by 54% vs 64% with placebo; this translated to a relative reduction of 16% in this population (P = .113).
Moreover, a 56% relative reduction in the number of days of SOM was reported in the investigative vs control arms. The number of days of SOM with avasopasem was 8 days vs 18 days with placebo (P = .011). A 27% relative reduction in severity of SOM was observed, with avasopasem reducing severity by 24% vs 33% with placebo (P = .167).
Galera Therapeutics, Inc., the drug developer, shared that they will continue to examine the results from the trial.
“While the data, as in previous trials, showed reductions in the incidence, duration, and severity of SOM, we are surprised and disappointed that the trial did not achieve statistical significance in its primary end point,” Mel Sorensen, MD, president and chief executive officer of Galera...
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