Galera Therapeutics Inc. (NASDAQ: GRTX) has announced that revised findings from the third phase ROMAN study of evasopasem for TY-induced severe oral mucositis treatment in patients with locally advanced head and neck cancer attained statistical significance on the primary reduction in SOM incidence endpoint. As a result, the US Food and Drug Administration (FDA) has given vasopasem Breakthrough Therapy Designation (BTD) for reducing SOM caused by RT.
Previously released results didn’t reach statistical significance
The Phase 3 ROMAN trial of avasopasem in SOM, which the Company previously announced, did not reach statistical significance on the primary outcome. After additional investigation, a statistical program error by the contract research organization (CRO) was discovered. The primary and secondary endpoints’ p-values improved once this inaccuracy was corrected.
CEO Mel Sorensens said, “Given the high unmet medical need for patients with head and neck cancer who develop radiotherapy-induced severe oral mucositis, we are gratified that the Phase 3 ROMAN trial achieved statistical significance on the primary endpoint after the correction of the statistical programming error. ROMAN is our second randomized trial conducted in patients with head and neck cancer to achieve statistical significance and demonstrate improved clinical benefit. As we continue to analyze the full data set and evaluate our resources, we look forward to meeting with the FDA in 2022 to discuss whether the results from this single Phase 3 trial together with the randomized Phase 2b trial could support an NDA submission.”
Garela released Phase 2a EUSOM study results
Garela also released topline data from the single-arm Phase 2a EUSOM study of avasopasem for RT-induced SOM in patients with HNC who were receiving standard-of-care RT + cisplatin in Europe. This study involved 38 patients at 12 centers across six European countries, with 33 of them completing the full course of treatment. Avasopasem appeared to be well tolerated by most people. In the EUSOM study, the incidence of SOM was 54.5 percent, with an average length of 9 days, similar to the ROMAN experiment, which had a 54 percent incidence and a mean duration of 8 days.