The primary end point of the ROMAN trial was not reached after avasopasem was found to not significantly reduce the incidence of severe oral mucositis. A full analysis of the results is ongoing.
Avasopasem manganese (avasopasem) does not significantly reduce the incidence of severe oral mucositis (SOM) in patients with locally advanced head and neck cancer, according to phase 3 study results announced in a press release by Galera Therapeutics, Inc.
Avasopasem is a selective small molecule dismutase mimetic. It was previously granted a fast track therapy designation by the FDA for the reduction of radiotherapy induced SOM with or without systemic therapy.
“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 endpoint,” said Mel Sorensen, MD, president and chief executive officer of Galera, in a press release. “We would like to extend our heartfelt thanks to the patients who participated in this trial while they underwent radiotherapy for head and neck cancer. As we evaluate next steps for this program, we remain committed to our goal of transforming radiotherapy in cancer treatment with our selective dismutase mimetics.”
These results fail to meet the primary end point of the phase 3 ROMAN study (NCT03689712) which compared avasopasem to placebo. The randomized, parallel assignment, quadruple masking, study has an...
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