Galera Therapeutics Announces Interim Data from Pilot Phase 1/2 Trial of GC4419 in Combination with Stereotactic Body Radiation Therapy Showed Improved Overall Survival in Patients with Locally Advanced Pancreatic Cancer
Initial results from pilot Phase 1/2 clinical trial in patients with locally advanced pancreatic cancer presented during virtual ASTRO Annual
First trial to evaluate anti-cancer activity of one of Galera’s dismutase mimetics in combination with SBRT
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MALVERN, Pa., Oct. 27, 2020 (GLOBE NEWSWIRE) -- 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, today announced interim data from the full patient population (n=42) in its Phase 1/2 clinical trial of avasopasem manganese (GC4419) in combination with stereotactic body radiation therapy (SBRT) in patients with locally advanced pancreatic cancer (LAPC). The data were presented today during the late-breaker special session of the 2020 American Society for Radiation Oncology (ASTRO) virtual Annual Meeting.
GC4419 is an investigational, highly selective small molecule superoxide dismutase mimetic designed to rapidly and selectively convert superoxide to hydrogen peroxide and oxygen. The randomized, double-blind, multicenter, placebo-controlled pilot dose escalation Phase 1/2 trial was designed to evaluate the safety and efficacy of GC4419 in combination with SBRT, compared with SBRT and placebo, in patients with LAPC. The trial assessed safety and efficacy of SBRT when combined with GC4419 or placebo. After completion of induction chemotherapy, patients were randomized (1:1) to receive five-fraction SBRT and 90 mg of GC4419 or placebo control by intravenous infusion one hour prior to each SBRT fraction.
In the interim analysis of the intent-to-treat population (n=42), median overall survival (OS) had not been reached at the data cutoff (date of August 24, 2020) in the GC4419 arm, compared to 38.7 weeks (HR=0.4; 95% CI: 0.12-1.11; p=0.06) in the placebo arm. Six-to-eight weeks post-SBRT, patients underwent protocol-specified evaluation for resection, and seven underwent resection. Of the patients in the GC4419 arm who were surgically resected (n=5), all achieved clear / negative margins (R0), one achieved pathological complete response (pCR) and four achieved pathological partial response (pPR), compared to one R0 and pPR of the two surgically resected patients in the placebo arm. No statistically significant differences in progression-free survival (PFS) were observed between GC4419 and placebo (HR=0.6; 95% CI: 0.23-1.56; p=0.29). However, patients were censored for PFS at the date of surgical resection or due to short interval follow up. Toxicity was comparable across both treatment arms, with no significant differences in acute (<90 days) or late (91-365 days) Grade 3+ toxicity post-SBRT.