Trial reportCancer research communications2025
Efficacy and Safety of Nivolumab Monotherapy in Patients with High PD-1-Positive CD8/Treg Ratio in Advanced NSCLC and Gastric Cancer: A Phase II, Multicenter Study.
Trial report in Cancer research communications, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
2 citing papers in PubMed.
- Real-World Outcomes and Safety of PD-1 Blockade Rechallenge Strategies After Prior Immunotherapy in Advanced NSCLC: A Retrospective Cohort Study.Drug design, development and therapy · 2026Article
- Review
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Authors and funding
19 authors.
Funding
Abstract
purposeIt is challenging to identify the appropriate patients who benefit from anti-PD-1/PD-L1 monotherapy. For predicting effectiveness of anti-PD-1/PD-L1 monotherapy, this open-label phase II study (ONO-4538-88) evaluated the potential of the tumor-infiltrating lymphocyte (TIL) biomarker: the balance between cytotoxic T cells and regulatory T cells. PATIENTS AND
methodsPatients with advanced non-small cell lung cancer (NSCLC) or gastric cancer were screened between March 2021 and January 2022. Eligible patients who met the prespecified TIL biomarker criteria received nivolumab monotherapy. The primary endpoint was objective response rate (ORR). The secondary endpoints included overall survival and progression-free survival. Conventional biomarkers (tumor proportion score, combined positive score, tumor mutation burden, and microsatellite instability) were exploratorily analyzed, and safety was also assessed.
resultsThirty-seven patients with NSCLC and 127 patients with gastric cancer were eligible for TIL analysis: 6 (16.2%) and 15 patients (11.8%) met the TIL biomarker criteria, respectively; a part of them were assessed. For NSCLC and gastric cancer, the ORR was 80% (4/5 patients) and 36.4% (4/11 patients), respectively; all the five patients and 5/11 patients had a reduction in tumor size, respectively; the median overall survival was not reached and 25 months, respectively; and the median progression-free survival was not reached and 5.59 months, respectively. Treatment-related adverse events occurred in 13/19 patients overall: 5/6 patients for NSCLC and 8/13 patients for gastric cancer.
conclusionsAlthough the low positive rate of the TIL biomarker limits interpretation, the promising ORRs suggest signs of the TIL biomarker's predictability for nivolumab monotherapy. SIGNIFICANCE: In this phase II study, we examined the predictive utility of the TIL biomarker for nivolumab monotherapy. Although the positivity of the TIL biomarker was limited, the promising efficacy and safety profile in the TIL biomarker-positive patients may suggest the potential utility of the TIL biomarker.
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