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Neoadjuvant modified FOLFIRINOX plus nivolumab in borderline-resectable pancreatic ductal adenocarcinoma: a pilot

Zev A Wainberg1,2,3, Jason M Link4,5, Alykhan Premji6

  • 1Department of Medicine, David Geffen School of Medicine at University of California Los Angeles, Los Angeles, CA, USA. zwainberg@mednet.ucla.edu.

Nature Communications
|January 31, 2026
PubMed

Insights

Neoadjuvant modified FOLFIRINOX plus nivolumab shows promise for borderline-resectable pancreatic cancer. The combination therapy demonstrated good safety and pathological response rates, with most patients proceeding to surgery.

Area of Science:

  • Oncology
  • Immunotherapy
  • Gastrointestinal Cancers

Background:

  • Pancreatic ductal adenocarcinoma (PDAC) has poor survival rates, with limited treatment options beyond surgery.
  • Chemotherapy and immune checkpoint inhibitors have shown minimal efficacy in advanced PDAC, except for rare microsatellite instability-high cases.
  • Neoadjuvant therapy aims to improve resectability and outcomes in borderline-resectable PDAC.

Purpose of the Study:

  • To evaluate the safety and pathological response of neoadjuvant modified FOLFIRINOX (mFFX) plus nivolumab in borderline-resectable PDAC.
  • To assess secondary endpoints including R0 resection rate, objective response rate, and survival outcomes.
  • To explore the immune microenvironment changes induced by the combination therapy.

Main Methods:

  • A single-arm, prospective phase 1b/2 investigator-initiated study (NCT03970252) was conducted.
  • Patients with borderline-resectable PDAC received neoadjuvant mFFX plus nivolumab.
  • Safety was assessed by treatment-related adverse events, and pathological response was evaluated by CAP scoring.

Main Results:

  • The co-primary endpoints of safety and pathological response were met.
  • 22 (79%) of 28 patients proceeded to surgery with no grade ≥3 immune-related adverse events.
  • Pathological response included 9% complete response, 9% near-complete response, and 72% partial response.
  • Median disease-free survival was 19.7 months, progression-free survival was 26 months, and overall survival was 38 months.
  • Exploratory analyses revealed increased intratumoral plasma cells and CD8 T cells, with specific lymphoid aggregate characteristics.

Conclusions:

  • Neoadjuvant mFFX plus nivolumab is a safe and effective treatment for borderline-resectable PDAC, improving pathological response and enabling surgery.
  • The combination therapy demonstrates encouraging survival outcomes and warrants further investigation.
  • The observed changes in the tumor immune microenvironment suggest potential mechanisms of action for the combination therapy.

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