Multicenter phase 1b-2 trial of SBRT with or without avasopasem for localized pancreatic ductal adenocarcinoma

Stereotactic body radiotherapy (SBRT) has the potential to ablate localized pancreatic ductal adenocarcinoma (PDAC). Selective dismutase mimetics sensitize tumors while reducing normal tissue toxicity. A randomized phase 1b-2 trial at six centers in the USA evaluated SBRT with or without the selective dismutase mimetic avasopasem manganese for borderline resectable or locally advanced PDAC. The trial showed that SBRT that uses 50 or 55 Gy in five fractions can be considered for patients with localized PDAC. Partial response was seen in 42% of the patients in the avasopasem group versus 17% of the patients in the placebo group. A larger phase 2 trial (GRECO-2) is underway to validate these results.