155P - Penpulimab combined with anlotinib and nab-paclitaxel plus gemcitabine (PAAG) as first-line treatment for advanced metastatic pancreatic cancer: A prospective, multicenter, single-arm, phase II study

Background

Chemotherapy currently serves as the cornerstone for treating metastatic pancreatic cancer (mPC). Nevertheless, the effectiveness of chemotherapy have yet to fully align with the demands and preferences of patients. There is an urgent necessity to delve into novel treatment avenues. Therefore, it is worth to assess the clinical value of combination of all three treatments. This study aims to evaluate the preliminary effectiveness and safety of penpulimab combined with anlotinib and nab-paclitaxel plus gemcitabine (PAAG) for mPC.

Methods

We conducted a phase Ⅱ prospective, single-arm, multicenter study involving first-line patients with histologically or cytologically confirmed mPC. Patients received penpulimab (200mg, IV, D1) and Anlotinib (12mg, P.O, QD, D1-14), in addition to nab-paclitaxel (125mg/m2, I.V, D1,8) and gemcitabine (1.0g/m2, I.V, D1,8), administered over a 21-day treatment cycle. The primary endpoints included the objective response rate (ORR) and disease control rate (DCR), while secondary endpoints encompassed Overall Survival (OS) (median), Progression-free Survival (PFS) (median), and safety.

Results

Between June 2022 and August 2023, 66 patients were enrolled. The longest treatment duration observed was 17 months. Out of these, 65 patients were eligible for response evaluation. The best response, indicated by the ORR, was recorded at 43% (28/65) (95%CI, 30.8-56.0), with 28 patients achieving partial response (PR). Notably, DCR stood at an impressive 95% (62/65) (95%CI, 87.1-99.0). The median PFS was calculated as 8.7 months. Grade 3 treatment-related adverse events (TRAEs) were reported in 39% patients (26/66). In prespecified exploratory transcriptomic biomarkers analysis, significantly higher expression of IFN-γ, T cell recruiting and Th17 recruiting scores were detected in CR/PR patients compared with SD/PD patients.

Conclusions

PAAG as first-line treatment demonstrated a promising efficacy and manageable AEs for mPC. Biomarkers identified in this study possessed the potential to guide the precise clinical application of PAAG.

Clinical trial identification

NCT05493995.

Editorial acknowledgement

Legal entity responsible for the study

Juan Du.

Funding

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Disclosure

All authors have declared no conflicts of interest.