MALVERN, PA — Galera Therapeutics, Inc. (Nasdaq: GRTX) has 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 this week 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.
“The survival rate in pancreatic cancer is dismal. Our goals for treatment are to extend survival and improve the potential for surgical resection, as surgery remains the only potentially curative therapy for pancreatic cancer,” said Sarah Hoffe, M.D., Section Head of GI Radiation Oncology and Senior Member at Moffitt Cancer Center, trial first author and investigator. “These interim data signal the potential of dismutase mimetics, when combined with SBRT, to prolong survival in patients with LAPC. Further study of dismutase mimetics to expand the utility of SBRT in pancreatic cancer treatment is warranted.”
The interim data includes all patients followed for a minimum of three months and 19 for more than one year, with data through August 24, 2020. The Company plans to provide an additional update on this trial with at least one year of follow up on all patients in the second half of 2021.
“We’re encouraged by the favorable overall survival benefit in this difficult-to-treat cancer observed in the interim data in this trial, which is the first trial evaluating the anti-cancer activity of one of Galera’s dismutase mimetics in combination with SBRT,” said Mel Sorensen, M.D., President and CEO of Galera. “Galera’s dismutase mimetics are designed to improve radiation therapy by both increasing therapeutic anti-tumor efficacy at higher doses of radiation and by protecting normal cells, and we look forward to advancing the development of this potential combination therapy and expanding into other cancers to improve outcomes for patients undergoing radiotherapy for the treatment of cancer.”
The Company plans to leverage observations from this pilot trial to further develop GC4711, its second superoxide dismutase mimetic clinical candidate, specifically for use in combination with SBRT, and anticipates initiating a follow-on Phase 2 trial in pancreatic cancer with GC4711 in combination with SBRT in the first half of 2021. Galera recently announced it is also evaluating the anti-cancer activity of GC4711 in an ongoing Phase 1/2 trial in combination with SBRT in patients with non-small cell lung cancer (NSCLC).
The presentation is available for on-demand viewing for registered ASTRO attendees for the next 30 days. Galera Therapeutics, Inc, headquartered in Malvern, PA, 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.
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