The dismutase mimetic avasopasem manganese (GC4419) was found to improve overall survival (OS), progression-free survival (PFS), local disease control, time to metastases, and tumor response rate compared with placebo in patients with unresectable or borderline resectable locally advanced pancreatic cancer who were undergoing stereotactic body radiation (SBRT), according to data from a phase 1/2b pilot trial (NCT03340974).1
At a minimum of 1 year of follow-up, improvements were observed across all efficacy parameters in the 42 patients enrolled to the double-blind, multicenter, placebo-controlled, proof-of-concept trial. Specifically, the hazard ratio (HR) for OS with the agent was 0.48 (95% CI, 0.20-1.14; P = .090). The HRs for PFS, local tumor control, and time to distant metastases were 0.46 (95% CI, 0.22-0.98; P = .040), 0.30 (95% CI, 0.08-1.10; P = .055), and 0.39 (95% CI, 0.16-0.93; P = .028), respectively.
Moreover, the agent was found to have favorable tolerability, with similar rates of early and late adverse effects (AEs) in both treatment arms.
“We are very pleased with the survival and tumor outcome benefits observed in the final analysis of this proof-of-concept trial,” Mel Sorensen, MD, president and chief executive officer of Galera Therapeutics, Inc., stated in the press release. “The improvements across multiple efficacy parameters, together with the safety data, are encouraging and underpin the rationale for our 160-patient blinded, randomized GRECO-2...
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