The CCTG PA.7 phase II trial of gemcitabine and nab-paclitaxel with or without durvalumab and tremelimumab as initial therapy in metastatic pancreatic ductal adenocarcinoma

Daniel J. Renouf (), Jonathan M. Loree, Jennifer J. Knox, James T. Topham, Petr Kavan, Derek Jonker, Stephen Welch, Felix Couture, Frederic Lemay, Mustapha Tehfe, Mohammed Harb, Nathalie Aucoin, Yoo-Joung Ko, Patricia A. Tang, Ravi Ramjeesingh, Brandon M. Meyers, Christina A. Kim, Pan Du, Shidong Jia, David F. Schaeffer, Sharlene Gill, Dongsheng Tu and Chris J O’Callaghan
Additional contact information
Daniel J. Renouf: Pancreas Centre BC
Jonathan M. Loree: Division of Medical Oncology, BC Cancer
Jennifer J. Knox: Princess Margaret Cancer Centre, UHN, University of Toronto
James T. Topham: Pancreas Centre BC
Petr Kavan: Sir Mortimer B. Davis Jewish General Hospital, Segal Cancer Centre, McGill University
Derek Jonker: University of Ottawa
Stephen Welch: London Regional Cancer Program
Felix Couture: Laval University
Frederic Lemay: University of Sherbrooke
Mustapha Tehfe: University of Montreal
Mohammed Harb: The Moncton City Hospital
Nathalie Aucoin: Hopital Cite-de-la-Sante
Yoo-Joung Ko: Sunnybrook Odette Cancer Centre
Patricia A. Tang: University of Calgary
Ravi Ramjeesingh: Nova Scotia Cancer Centre and Dalhousie University
Brandon M. Meyers: Juravinski Cancer Centre
Christina A. Kim: CancerCare Manitoba
Pan Du: Predicine, Inc.
Shidong Jia: Predicine, Inc.
David F. Schaeffer: Pancreas Centre BC
Sharlene Gill: Division of Medical Oncology, BC Cancer
Dongsheng Tu: Queen’s University
Chris J O’Callaghan: Queen’s University

Nature Communications, 2022, vol. 13, issue 1, 1-8

Abstract: Abstract Immunotherapy-based monotherapy treatment in metastatic pancreatic ductal adenocarcinoma (mPDAC) has shown limited benefit outside of the mismatch repair deficiency setting, while safety and efficacy of combining dual-checkpoint inhibitor immunotherapy with chemotherapy remains uncertain. Here, we present results from the CCTG PA.7 study (NCT02879318), a randomized phase II trial comparing gemcitabine and nab-paclitaxel with and without immune checkpoint inhibitors durvalumab and tremelimumab in 180 patients with mPDAC. The primary endpoint was overall survival. Secondary endpoints included progression-free survival and objective response rate. Results of the trial were negative as combination immunotherapy did not improve survival among the unselected patient population (p = 0.72) and toxicity was limited to elevation of lymphocytes in the combination immunotherapy group (p = 0.02). Exploratory baseline circulating tumor DNA (ctDNA) sequencing revealed increased survival for patients with KRAS wildtype tumors in both the combination immunotherapy (p = 0.001) and chemotherapy (p = 0.004) groups. These data support the utility of ctDNA analysis in PDAC and the prognostic value of ctDNA-based KRAS mutation status.

Date: 2022
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DOI: 10.1038/s41467-022-32591-8

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