In a phase 3 clinical trial, avasopasem appeared to lower the rate of severe oral mucositis in patients.
A correction to efficacy data allowed avasopasem (GC4419) to meet its primary end point of a relative reduction in the incidence of severe oral mucositis (SOM) in patients with locally advanced head and neck cancer (HNC) treated in the phase 3 ROMAN trial, according to Galera Therapeutics, Inc.1
In the study, avasopasem is undergoing evaluation as a treatment for radiotherapy (RT)-induced SOM in patients with locally advanced HNC. The FDA granted avasopasem a breakthrough therapy designation for the reduction of SOM induced by RT.
In the phase 3 ROMAN trial (NCT03689712), the incidence of SOM in the treatment group was 54% compared with 64% for the placebo group.2 After re-analysis, the difference in statistical significance improved for the treatment arm (initial P = .113 vs corrected P = .0451).
Secondary end points include number of days experiencing SOM and severity. The relative reduction in the number of days patients experienced SOM in the avasopasem treatment group was 8 days vs. 18 days for the placebo group (initial P =.011 vs corrected P =.0022). Also, the relative reduction in the severity (incidence of Grade 4 OM) of SOM in the avasopasem treatment group was 24%) versus 33% for the placebo group (initial P =.167 vs corrected P =.052).
The trial was previously reported to have not achieved statistical significance to the primary end point. It was found that an error was made by the contracted research organization which aided the study. The corrected errors showed improvement in both primary and secondary end points.
Patients (n = 455) were randomized to receive a 60-minute infusion of avasopasem or a 60-minute infusion of placebo. Eligible patients were 18 years or older, had an ECOG performance no greater than 2, and adequate hematologic, renal, and liver function.
“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 end point after the correction of the statistical programming error,” said Mel Sorensen, MD, president and CEO of Galera, in a press release. “ROMAN is our second randomized trial conducted in patients with head and neck cancer to achieve statistical significance and demonstrate improved clinical benefit.”
Galera plans to discuss these corrected data with the FDA in 2022.
1. Galera Announces Primary Endpoint Met Statistical Significance in Corrected Topline Efficacy Data of Phase 3 ROMAN Trial of Avasopasem. News release. Galera Therapeutics, Inc. December 14, 2021. Accessed December 14, 2021. https://investors.galeratx.com/news-releases/news-release-details/galera-announces-primary-endpoint-met-statistical-significance
2. Anderson CM, Lee CM, Saunders DP, et al. Phase IIb, randomized, double-blind trial of gc4419 versus placebo to reduce severe oral mucositis due to concurrent radiotherapy and cisplatin for head and neck cancer [published correction appears in J Clin Oncol. 2020 Jan 20;38(3):288]. J Clin Oncol. 2019;37(34):3256-3265. doi:10.1200/JCO.19.01507