In patients with borderline resectable or locally advanced pancreatic ductal adenocarcinoma, the researchers sought to compare the effectiveness and safety of algenpantucel-L [HyperAcute-Pancreas algenpantucel-L (HAPa); IND# 12,311] immunotherapy associated with standard of care (SOC) chemotherapy and chemoradiation to SOC chemotherapy and chemoradiation therapy alone (PDAC). Patients with borderline resectable or locally advanced unresectable PDAC were enrolled in a multicenter, phase 3 open-label, randomized (1:1) experiment. Patients were given either conventional neoadjuvant SOC chemotherapy (FOLFIRINOX or gemcitabine/nab-paclitaxel) followed by chemoradiation (control group) or the same standard neoadjuvant chemotherapy plus HAPa immunotherapy (experimental group) (experimental group). Overall, survival was the most important outcome. About 303 participants were randomized from 32 sites between May 2013 and December 2015. Overall survival in the conventional group (N=158) was 14.9 (12.2–17.8) months, but in the experimental group (N=145) it was 14.3 (12.6–16.3) months [hazard ratio (HR) 1.02, 95% CI 0.66–1.58; P=0.98]. The conventional group had a median progression-free survival of 13.4 months, while the experimental group had a median progression-free survival of 12.4 months (HR 1.33, 95% CI 0.72–1.78; P=0.59). In the conventional group, 105 of 140 patients (75%) experienced grade 3 or greater adverse events, compared to 115 of 142 patients (81%) in the experimental group (P>0.05). Patients with borderline resectable or locally advanced unresectable PDAC who received SOC neoadjuvant chemotherapy and chemoradiation did not benefit from algenpantucel-L immunotherapy.
Source:journals.lww.com/annalsofsurgery/Abstract/2022/01000/A_Phase_3_Randomized_Clinical_Trial_of.10.aspx
