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<p>The CCTG PA.7 study was a randomized phase II trial comparing chemotherapy with and without dual immune checkpoint inhibition in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC). In follow-up to the published primary results of the trial, the analysis herein focused on long-term survival and exploratory analysis.Plasma sequencing analysis identified concurrent mutations in DNA damage repair genes <i>BRCA1, POLE, ATM</i> and <i>FANCA</i> in 18/173 (10.40%) of patients, and presence of two or more mutations in these genes was associated with overall survival benefit for patients receiving immunotherapy (median overall survival 26.2 vs. 9.7 months; hazard ratio, 0.34; 95% CI, 0.16–0.68; p = 0.001; interaction p = 0.003). Partial response was observed in 7/11 (63.64%) patients with concurrent DNA damage repair gene mutations in the immunotherapy arm. As a prospective study in PDAC identifying a potential biomarker beyond mismatch repair deficiency for benefit from immunotherapy, these data highlight an actionable subgroup of mPDAC.</p>

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DNA Repair gene alterations and efficacy from gemcitabine and nab-paclitaxel with/without durvalumab and tremelimumab in metastatic pancreatic ductal adenocarcinoma

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年3月7日

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  • Daniel J. Renouf,
  • James T. Topham,
  • Jonathan M. Loree,
  • David F. Schaeffer,
  • Jennifer J. Knox,
  • 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,
  • Joanna M. Karasinska,
  • Sharlene Gill,
  • Dongsheng Tu,
  • Chris J. O’Callaghan

摘要

The CCTG PA.7 study was a randomized phase II trial comparing chemotherapy with and without dual immune checkpoint inhibition in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC). In follow-up to the published primary results of the trial, the analysis herein focused on long-term survival and exploratory analysis.Plasma sequencing analysis identified concurrent mutations in DNA damage repair genes BRCA1, POLE, ATM and FANCA in 18/173 (10.40%) of patients, and presence of two or more mutations in these genes was associated with overall survival benefit for patients receiving immunotherapy (median overall survival 26.2 vs. 9.7 months; hazard ratio, 0.34; 95% CI, 0.16–0.68; p = 0.001; interaction p = 0.003). Partial response was observed in 7/11 (63.64%) patients with concurrent DNA damage repair gene mutations in the immunotherapy arm. As a prospective study in PDAC identifying a potential biomarker beyond mismatch repair deficiency for benefit from immunotherapy, these data highlight an actionable subgroup of mPDAC.