FDA Receives New Drug Application for Avasopasem to Treat Radiotherapy-Induced Severe Oral Mucositis in Head and Neck Cancer

The new drug application for avasopasem for radiotherapy-induced severe oral mucositis in patients with head and neck cancer is supported by findings from the phase 3 ROMAN trial and phase 2b GT-201 trial.

A new drug application for avasopasem (GC4419) was submitted to the FDA for the treatment of radiotherapy-induced severe oral mucositis in those diagnosed with head and neck cancer, according to a press release from Galera Therapeutics.

The application was supported by positive data from the phase 3 ROMAN trial and phase 2b GT-201 trial, both of which assessed avasopasem for radiation-induced severe oral mucositis (SOM) in patients with head and neck cancer.

“With submission of this NDA, we achieved an important milestone towards our goal of transforming radiotherapy, potentially bringing patients with [head and neck cancer] the first approved drug for SOM and relief from its tremendous burden,” Mel Sorensen, MD, president and CEO of Galera Therapeutics.

In a population of 455 patients, treatment with avasopasem resulted in a meaningful reduction in SOM burden across numerous end points, including a statistically significant reduction in incidence, number of days of SOM, and reducing the number of days SOM lasted.

Moreover, there was a significant reduction in patients who developed grade 4 SOM. The study's exploratory analyses identified clinical benefit in terms of SOM onset and incidence burden, as well as a long-lasting reduction in loss of kidney function associated with cisplatin.

The agent was also well tolerated vs placebo, according to the release.

Findings from the GT-201 trial highlighted a meaningful reduction in SOM burden across multiple end points in a population of 223 patients. Moreover, investigators reported a statistically significant reduction in number of SOM days with a 90 mg dose of avasopasem compared with placebo.

Avasopasem also improved the incidence, severity, and onset of SOM vs placebo. The agent was also well tolerated vs placebo. These findings led to the FDA granting avasopasem breakthrough therapy designation.

The randomized, double-blind, placebo-controlled trial comprised patients with locally advanced head and neck cancer who were treated with standard of care radiotherapy and cisplatin for 7 weeks. The patients were randomly assigned 3:2 to be treated with 90 mg of cisplatin or placebo intravenously on the same days they were treated with radiotherapy.

Additionally, the randomized, double-blind, placebo-controlled GT-201 trial also assessed avasopasem in a population with locally advanced head and neck cancer that was undergoing treatment with standard of care radiotherapy and cisplatin for 7 weeks.

Those who were included in the study were randomly assigned 1:1:1 to be treated with avasopasem at either 30 mg or 90 mg, or the placebo arm intravenously on the same days as radiation therapy.

Reference

Galera submits new drug application for avasopasem for severe oral mucositis. News release. Galera Therapeutics. December 12, 2022. Accessed December 12, 2022. https://bit.ly/3uJlztq