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
- Huizi Sha 1, Fan Tong 2, Jiayao Ni 2, Yi Sun 1, Yahui Zhu 1, Liang Qi 1, Xiaoqin Li 3, Wei Li 4, Yan Yang 5, Qing Gu 6, Xing Zhang 7, Xiaoxuan Wang 7, Chan Zhu 7, Dongsheng Chen 7, Baorui Liu 8, Juan Du 9,10
- 1The Comprehensive Cancer Center, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University & Clinical Cancer Institute of Nanjing University, Nanjing, China.
- 2The Comprehensive Cancer Center, Nanjing Drum Tower Hospital, Clinical College of Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine, Nanjing, China.
- 3Department of Oncology, The Affiliated Hospital of Jiangsu University, Zhenjiang, China.
- 4Department of Oncology, The First Affiliated Hospital of Soochow University, Suzhou, China.
- 5Department of Oncology, The Affiliated Jiangning Hospital of Nanjing Medical University, Nanjing, China.
- 6National Institute of Healthcare Data Science at Nanjing University, Nanjing, China.
- 7State Key Laboratory of Neurology and Oncology Drug Development, Jiangsu Simcere Diagnostics Co., Ltd., Nanjing Simcere Medical Laboratory Science Co., Ltd., Nanjing, China.
- 8The Comprehensive Cancer Center, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University & Clinical Cancer Institute of Nanjing University, Nanjing, China. baoruiliu@nju.edu.cn.
- 9The Comprehensive Cancer Center, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University & Clinical Cancer Institute of Nanjing University, Nanjing, China. dujuanglyy@163.com.
- 10The Comprehensive Cancer Center, Nanjing Drum Tower Hospital, Clinical College of Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine, Nanjing, China. dujuanglyy@163.com.
- 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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View abstract on PubMed
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.
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