Galera Therapeutics announces results of phase III ROMAN trial of avasopasem for radiotherapy-induced severe oral mucositis.

The trial did not meet its primary endpoint of reduction in the incidence of SOM.

The Company is continuing to analyze the results. 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, M.D., Galera’s President and CEO. “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.”

Key findings include i. 16% relative reduction in the incidence of SOM in the avasopasem treatment group (54%) vs. placebo group (64%) (p=0.113) (primary endpoint). ii. 56% relative reduction in the number of days of SOM in the avasopasem treatment group (8 days) vs. placebo group (18 days) (p=0.011) (secondary endpoint). iii. 27% relative reduction in the severity (incidence of Grade 4 OM) of SOM in the avasopasem treatment group (24%) vs. placebo group (33%) (p=0.167) (secondary endpoint) Avasopasem was generally well tolerated with similar rates of adverse events in the active and placebo arms.

Dr. Sorensen continued, “We continue to be excited about the potential of our second dismutase mimetic product candidate, GC 4711, in clinical-stage development to augment the anti-cancer efficacy of stereotactic body radiation therapy (SBRT) in patients with non-small cell lung cancer (NSCLC) and locally advanced pancreatic cancer (LAPC). We recently initiated a Phase IIb trial of GC 4711 in combination with SBRT in LAPC based on promising tumor and survival outcome benefits observed in a Phase 1/II pilot trial. In addition, enrollment is ongoing in a Phase 1/II trial of GC 4711 in combination with SBRT in patients with NSCLC. We look forward to providing updates as these trials progress.”

The ROMAN trial is a randomized, double-blind, placebo-controlled trial in 455 patients with locally advanced HNC receiving seven weeks of standard-of-care radiotherapy plus cisplatin. Patients were randomized to one of the two treatment groups (3:2) to receive 90 mg of avasopasem or placebo by infusion on the days they receive their radiation treatment.