MALVERN, PA — Galera Therapeutics, Inc. (Nasdaq: GRTX) announced updated results from its Phase 1/2 pilot trial of GC4419, versus placebo, in patients with locally advanced pancreatic cancer (LAPC) who are undergoing stereotactic body radiation therapy (SBRT). The updated results, as of this data analysis, include a minimum follow up of six months on all 42 patients and were consistent with the positive results reported with a minimum follow up of three months. The Company plans to report final results from the trial after a minimum of one year of follow up, expected during the second half of 2021.
“The data from this trial continue to impress, showing consistent and durable benefits across multiple measures, including the most important for the patient, overall survival,” said Mel Sorensen, M.D., President and CEO of Galera. “These encouraging results informed the design of our Phase 2b GRECO-2 trial and underscore our excitement about the potential to make a meaningful difference for patients with this tough diagnosis.”
As of this data analysis, median overall survival in the treatment arm was nearly twice as long as observed in the placebo arm, 20.1 months compared to 10.9 months, respectively. 29% of patients in the treatment arm achieved a 30% or greater response (partial response) compared to 11% of patients in the placebo arm. Positive results were also observed in local tumor control, time to metastases and progression-free survival. As previously reported, GC4419 was well tolerated as of this data analysis, with similar rates of adverse events in the treatment and placebo arms.
“There are limited treatment options for patients with locally advanced pancreatic cancer and we are continually looking for innovative approaches,” said Sarah Hoffe, M.D., Section Head of GI Radiation Oncology at H. Lee Moffitt Cancer Center and Research Institute. “These pancreatic data are exciting and speak to the potential emergence of an entirely novel class of cancer therapeutics for patients.”
Galera’s selective dismutase mimetic product candidates are small molecules being developed to protect normal cells and sensitize cancer cells to radiotherapy. The Phase 1/2 pilot trial is a randomized, double-blind, multicenter, placebo-controlled trial in 42 patients diagnosed with LAPC evaluating the safety and efficacy of SBRT and the dismutase mimetic GC4419 compared to SBRT and placebo. Patients were randomized (1:1) to receive GC4419 or placebo by intravenous infusion one hour prior to SBRT.
The data from this trial support GRECO-2, a multicenter, randomized, double-blind, placebo-controlled Phase 2b trial to evaluate GC4711, Galera’s second dismutase mimetic product candidate, combined with SBRT in patients with LAPC. The primary endpoint of the Phase 2b trial is overall survival. The Company expects to initiate patient dosing in GRECO-2 in the first half of 2021, and the trial is expected to enroll approximately 160 patients.
Galera Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutic candidates that have the potential to transform radiotherapy in cancer.
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