Galera Therapeutics Inc (NASDAQ: GRTX) has announced updated results from its Phase 1/2 pilot trial evaluating GC4419 in patients with locally advanced pancreatic cancer (LAPC) who are undergoing stereotactic body radiation therapy (SBRT).
The company plans to report final results from the trial during the second half of 2021.
As of this data analysis, median overall survival in the treatment arm was nearly twice as long as observed in the placebo arm (placebo + SBRT), 20.1 months compared to 10.9 months, respectively.
29% of patients in the treatment arm achieved a 30% or greater response (partial response) than 11% of patients in the placebo arm.
Positive results were also observed in local tumor control, time to metastases, and progression-free survival.
The data from this trial support the GRECO-2 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. Patient dosing will start in the first half of 2021, and the trial is expected to enroll approximately 160 patients.
GC4419, also referred to as avasopasem, is the company's lead candidate.
It is a small-molecule dismutase mimetic initially being developed for the reduction of radiation-induced severe oral mucositis.
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