On May 26, 2022 Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, reported data from its Phase 3 ROMAN trial of avasopasem for severe oral mucositis will be highlighted in an oral presentation at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on Friday, June 3, 2022 from 2:45 p.m. – 5:45 p.m. CDT during the Head and Neck Cancer session (Press release, Galera Therapeutics, MAY 26, 2022, View Source [SID1234615084]). Topline data was announced in December 2021. Abstracts are currently available in the ASCO (Free ASCO Whitepaper) digital program.

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"We are pleased that our Phase 3 trial of avasopasem was selected for an oral presentation at ASCO (Free ASCO Whitepaper), where details of the clinically meaningful and statistically significant results will be shared," said Mel Sorensen, M.D., Galera’s President and CEO. "Our research shows that radiation oncologists and patients cite SOM as the most burdensome radiotherapy toxicity in head and neck cancer treatment, and there are currently no FDA-approved drugs to reduce the incidence or duration of SOM in solid tumors. Avasopasem has been granted Breakthrough Therapy and Fast Track Designations by the U.S. FDA for the reduction of SOM induced by radiotherapy, and we look forward to submitting a New Drug Application to the FDA by year end in order to bring this potential treatment to patients as quickly as possible."

Results from the 455-patient Phase 3 trial demonstrated a meaningful reduction in patients’ SOM burden across multiple endpoints, with statistically significant reductions on the primary endpoint of incidence of SOM and the secondary endpoint of number of days of SOM, more than halving the median number of days a patient suffered SOM. Exploratory analyses, such as time to SOM onset and SOM incidence at various landmarks of radiotherapy delivered, also demonstrated clinical benefit of avasopasem in reducing the burden of SOM. Avasopasem also appeared to be generally well tolerated compared to placebo. These results are consistent with those from the positive 223-patient Phase 2b trial (Anderson, J Clin Oncol, 2019) that was the basis for Breakthrough Therapy Designation.

Additionally, Galera’s Phase 2 GRECO-2 study of rucosopasem (GC4711) in combination with stereotactic body radiation therapy in pancreatic cancer will be presented at the ASCO (Free ASCO Whitepaper) Annual Meeting in a Trials in Progress poster session on Saturday, June 4, 2022, from 8:00 a.m. – 11:00 a.m. CDT. The primary endpoint of this trial is overall survival.

About Severe Oral Mucositis (SOM)
Approximately 42,000 patients with head and neck cancer undergo standard-of-care radiotherapy every year in the U.S. and are at risk of experiencing SOM. In patients with head and neck cancer, radiotherapy is a mainstay of treatment. Approximately 70 percent of patients receiving radiotherapy for head and neck cancer develop SOM, defined by the inability to eat solid food or drink liquids. The impact on patients who develop SOM is substantial, particularly when hospitalization and/or surgical placement of PEG tubes to maintain nutrition and hydration are required. SOM can adversely affect cancer treatment outcomes by causing interruptions in radiotherapy, which may compromise the otherwise good prognosis for tumor control in many of these patients. There is currently no drug approved to prevent or treat SOM for these patients.

About Avasopasem
Avasopasem manganese (avasopasem, or GC4419) is a selective small molecule dismutase mimetic in development for the reduction of radiation-induced severe oral mucositis (SOM) in patients with locally advanced head and neck cancer (HNC) and for the reduction of radiation-induced esophagitis in patients with lung cancer. The FDA has granted Fast Track and Breakthrough Therapy designations to avasopasem for the reduction of SOM induced by radiotherapy, with or without systemic therapy.