First-line penpulimab (an anti-PD1 antibody) and anlotinib (an angiogenesis inhibitor) with nab-paclitaxel/gemcitabine (PAAG) in metastatic pancreatic cancer: a prospective, multicentre, biomolecular exploratory, phase II trial

  • 0The Comprehensive Cancer Center, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University & Clinical Cancer Institute of Nanjing University, Nanjing, China.

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Summary

This summary is machine-generated.

This study shows that the PAAG combination therapy offers promising efficacy and tolerability for first-line metastatic pancreatic cancer (mPC), with a 50% objective response rate and a 95.5% disease control rate.

Area Of Science

  • Oncology
  • Clinical Trials
  • Cancer Research

Background

  • Metastatic pancreatic cancer (mPC) presents a significant clinical challenge with poor patient outcomes.
  • Current first-line treatments for mPC have limitations, necessitating novel therapeutic strategies.

Purpose Of The Study

  • To evaluate the efficacy and safety of penpulimab and anlotinib in combination with nab-paclitaxel/gemcitabine (PAAG) for first-line mPC.
  • To identify potential predictive biomarkers for treatment response in mPC.

Main Methods

  • A prospective, multicentre, single-arm, phase II clinical trial (NCT05493995) was conducted.
  • The study enrolled patients with first-line mPC, assessing objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety.
  • Exploratory analyses investigated correlations between molecular alterations (SWI/SNF complex) and immune cell profiles with treatment outcomes.

Main Results

  • The PAAG regimen achieved an ORR of 50.0% and a DCR of 95.5% in 66 efficacy-evaluable patients.
  • Median PFS was 8.8 months and median OS was 13.7 months.
  • Grade 3/4 treatment-related adverse events occurred in 39.4% of patients. Altered SWI/SNF complex was associated with poorer PFS.

Conclusions

  • The PAAG triple-combination therapy demonstrates promising clinical efficacy and acceptable tolerability as a first-line treatment for mPC.
  • Baseline biomarkers including serum CA724 levels, T-cell and Th17 cell recruitment, and NK CD56dim cell scores may predict treatment response.
  • These findings support the potential of PAAG for precise clinical application in mPC management.