Authors
Lacey J Padrón, Deena M Maurer, Mark H O’Hara, Eileen M O’Reilly, Robert A Wolff, Zev A Wainberg, Andrew H Ko, George Fisher, Osama Rahma, Jaclyn P Lyman, Christopher R Cabanski, Jia Xin Yu, Shannon M Pfeiffer, Marko Spasic, Jingying Xu, Pier Federico Gherardini, Joyson Karakunnel, Rosemarie Mick, Cécile Alanio, Katelyn T Byrne, Travis J Hollmann, Jonni S Moore, Derek D Jones, Marco Tognetti, Richard O Chen, Xiaodong Yang, Lisa Salvador, E John Wherry, Ute Dugan, Jill O’Donnell-Tormey, Lisa H Butterfield, Vanessa M Hubbard-Lucey, Ramy Ibrahim, Justin Fairchild, Samantha Bucktrout, Theresa M LaVallee, Robert H Vonderheide
Publication date
2022/6
Journal
Nature medicine
Volume
28
Issue
6
Pages
1167-1177
Publisher
Nature Publishing Group US
Description
Chemotherapy combined with immunotherapy has improved the treatment of certain solid tumors, but effective regimens remain elusive for pancreatic ductal adenocarcinoma (PDAC). We conducted a randomized phase 2 trial evaluating the efficacy of nivolumab (nivo; anti-PD-1) and/or sotigalimab (sotiga; CD40 agonistic antibody) with gemcitabine/nab-paclitaxel (chemotherapy) in patients with first-line metastatic PDAC (NCT03214250). In 105 patients analyzed for efficacy, the primary endpoint of 1-year overall survival (OS) was met for nivo/chemo (57.7%, P = 0.006 compared to historical 1-year OS of 35%, n = 34) but was not met for sotiga/chemo (48.1%, P = 0.062, n = 36) or sotiga/nivo/chemo (41.3%, P = 0.223, n = 35). Secondary endpoints were progression-free survival, objective response rate, disease control rate, duration of response and safety. Treatment-related adverse event rates were …
Total citations
Scholar articles
LJ Padrón, DM Maurer, MH O'Hara, EM O'Reilly… - Nature medicine, 2022