Galera Announces Oral Presentation at 2022 American Society of Clinical Oncology

Galera Therapeutics

MALVERN, PA — Galera Therapeutics, Inc. (Nasdaq: GRTX) recently announced 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) Annual Meeting on Friday, June 3, 2022, from 2:45 p.m. – 5:45 p.m. CDT during the Head and Neck Cancer session. Topline data was announced in December 2021. Abstracts are currently available in the ASCO digital program.

“We are pleased that our Phase 3 trial of avasopasem was selected for an oral presentation at ASCO, 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.

READ:  Ocugen, Inc. to Present at Chardan’s 6th Annual Genetic Medicines Conference

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 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.

For the latest news on everything happening in Chester County and the surrounding area, be sure to follow MyChesCo on Google News.

Thanks for visiting! Looking for some Chester County pride? We got you covered! Shop our MyChesCo store and show your love for Chester County, Pennsylvania. We got shirts, hats, and more – all with a unique ChesCo flair. Plus, proceeds from each purchase helps support our mission of bringing reliable information and resources to the people of Chester County.