GC4419 plus radiation improved progression-free survival and time to distant metastases in patients with unresectable or borderline resectable locally advanced pancreatic cancer.
Results from an ongoing phase 2b GRECO-2 clinical trial show that the novel drug GC4419 may be promising in treating patients with unresectable or borderline resectable locally advanced pancreatic cancer who are undergoing stereotactic body radiation therapy (SBRT).
When given with SBRT, the drug led to statistically significant improvements over placebo plus SBRT in progression-free survival (PFS; the time a patient lives without their disease getting worse) and time to distant metastases. There were also trends toward better overall survival and local tumor control.
At the study’s last follow-up, 46% of patients in the GC4419 group were alive compared with 33% in the placebo group, and 29% of patients on the drug achieved a partial response, defined as a 30% or more shrink in tumor size.
“We are excited to see the final results from this trial and enthusiastic to participate in the Phase 2b GRECO-2 trial,” said Dr. Sarah Hoffe, Section Head of GI Radiation Oncology at H. Lee Moffitt Cancer Center and Research Institute, in a statement. “These observed overall survival rates are particularly encouraging in pancreatic cancer, as this patient population faces a difficult diagnosis with high rates of distant metastasis and low rates of cure.”
GC4419 is a selective superoxide dismutase mimetic, a kind of drug that helps to control the growth of tumors without compromising the safety of radiation treatment. Patients enrolled on the clinical trial received intravenous GC4419 or placebo one hour before undergoing SBRT.
“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 trial of GC4711 with SBRT in pancreatic cancer, where the primary endpoint is overall survival. These are exciting times for Galera as we also look forward to announcing topline data from our ROMAN Phase 3 trial for the reduction of severe oral mucositis in patients with head and neck cancer later this year,” said Dr. Mel Sorensen, president and CEO of Galera Therapeutics, the manufacturer of the drug.
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