The activity and immune dynamics of PD-1 inhibition on high-risk pulmonary ground glass opacity lesions: insights from a single-arm, phase II trial

Quick Facts

  • Publication title: The activity and immune dynamics of PD-1 inhibition on high-risk pulmonary ground glass opacity lesions: insights from a single-arm, phase II trial
  • Journal: Signal Transduct Target Ther
  • Year: 2024
  • DOI: 10.1038/s41392-024-01799-z
  • PMID/PMCID: 38637495; PMC11026465

Research overview

The primary endpoint was objective response rate (ORR). This is a single-arm, phase II trial (NCT04026841) using Simon's optimal two-stage design, of which 4 doses of sintilimab (200 mg per 3 weeks) were administrated in 36 enrolled multiple primary lung cancer (MPLC) patients with persistent high-risk (Lung-RADS category 4 or had progressed within 6 months) GGOs.

Key findings

Immune checkpoint inhibitors targeting the programmed cell death-1 (PD-1) protein significantly improve survival in patients with advanced non-small-cell lung cancer (NSCLC), but its impact on early-stage ground-glass opacity (GGO) lesions remains unclear.

This is a single-arm, phase II trial (NCT04026841) using Simon's optimal two-stage design, of which 4 doses of sintilimab (200 mg per 3 weeks) were administrated in 36 enrolled multiple primary lung cancer (MPLC) patients with persistent high-risk (Lung-RADS category 4 or had progressed within 6 months) GGOs.

The primary endpoint was objective response rate (ORR).

T/B/NK-cell subpopulations, TCR-seq, cytokines, exosomal RNA, and multiplexed immunohistochemistry (mIHC) were monitored and compared between responders and non-responders.

Echo Biotech Role

Echo Biotech contributed EV isolation and purification, EV characterization, lncRNA/mRNA sequencing; the study also used or cited Exosupur®.

Related platforms: Exoomics®, Research Reagents & Tools

Related services and capabilities: Biofluid EV Isolation & Purification, EV Basic Characterization (TEM/NTA/WB), EV lncRNA/mRNA Sequencing, Research Reagent / Product Supply

Related products or reagents: Exosupur® EV Isolation/Purification Kit

References

Original publication: The activity and immune dynamics of PD-1 inhibition on high-risk pulmonary ground glass opacity lesions: insights from a single-arm, phase II trial Signal transduction and targeted therapy. 2024. DOI: 10.1038/s41392-024-01799-z. PMID/PMCID: 38637495; PMC11026465.