• 国家药监局综合司 国家卫生健康委办公厅
  • 国家药监局综合司 国家卫生健康委办公厅

Clinical Efficacy of Penpulimab Combined Chemotherapy in Non-Squamous NSCLC

Corresponding author: HU Wei,, 13938592975@139.cpm
DOI: 10.12201/bmr.202508.00045
Statement: This article is a preprint and has not been peer-reviewed. It reports new research that has yet to be evaluated and so should not be used to guide clinical practice.
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    Abstract: Objective To evaluate the clinical efficacy of Penpulimab, a novel domestic PD-1 inhibitor, combined with chemotherapy in the treatment of advanced non-squamous non-small cell lung cancer (Non-Small Cell Lung Cancer, NSCLC). Methods Patients diagnosed with metastatic or locally advanced non-squamous NSCLC in our hospital from October 2021 to December 2022 were retrospectively selected and divided into a control group (receiving standard platinum-containing dual drug chemotherapy) and an observation group (receiving piamprimab combined chemotherapy). The objective response rate (Objective response rate,ORR), progression-free survival (PFS), tumor markers (CYFRA21-1 and CEA), immune function indicators (CD3+, CD4+, CD8+ cell positivity, and CD4+/CD8+ ratio), and adverse events were compared between the two groups. Results After six cycles of treatment, the ORR in the observation group was significantly higher than that in the control group (55.6% vs. 34.4%, P=0.029), and the PFS was also significantly longer (17.0 months vs. 11.0 months, P<0.05). Post-treatment, CYFRA21-1 and CEA levels were significantly lower in the observation group compared to the control group (P<0.05). Additionally, immune function analysis showed that CD3+ and CD4+ cell positivity and the CD4+/CD8+ ratio significantly increased, while CD8+ cell positivity decreased, with a greater improvement observed in the observation group (P<0.05). Both groups experienced varying degrees of adverse effects; however, symptoms were effectively managed. No statistically significant differences were found between the two groups regarding nausea, vomiting, anemia, hepatotoxicity, nephrotoxicity, or rash (P>0.05), but the incidence of neutropenia was higher in the observation group (P<0.05). Conclusion The combination of Penpulimab with platinum-based chemotherapy significantly improves treatment efficacy, reduces tumor marker levels, enhances immune function, and prolongs progression-free survival in patients with advanced non-squamous NSCLC.

    Key words: Non-squamous NSCLC; Penpulimab; Chemotherapy; Immunotherapy; Survival

    Submit time: 22 August 2025

    Copyright: The copyright holder for this preprint is the author/funder, who has granted biomedRxiv a license to display the preprint in perpetuity.
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    1 2025-04-14

    bmr.202508.00045V1

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HU Wei,. Clinical Efficacy of Penpulimab Combined Chemotherapy in Non-Squamous NSCLC. 2025. biomedRxiv.202508.00045

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