Jul. 7 at 11:17 AM
$BYSI BeyondSpring announces publication of human clinical study on plinabulin
BeyondSpring announced publication of a human clinical study in Med demonstrating that Plinabulin, when combined with radiation and a checkpoint inhibitor, induces dendritic cell maturation and elicits tumor responses in patients across multiple cancer types who had failed prior ICI therapy. The study also identified a potential biomarker-baseline GEF-H1 immune signature-that may enable patient pre-selection and clinical response prediction. Triple I/O Combination Study Highlights:
This investigator-initiated, Phase 1 translational trial evaluated a triple immunotherapy approach combining Plinabulin, radiation, and anti-PD-1 checkpoint inhibitors in patients with eight cancer types who are refractory or relapsed on prior ICI therapy. RT was administered only during the first cycle. The primary endpoint was tumor response in non-irradiated lesions. Clinical Results: Nineteen patients received the combination regimen-14 on pembrolizumab and 5 on nivolumab.
Tumor responses were evaluable in 13 ICI-relapsed patients across eight tumor types. Objective response rate was 23%, and disease control rate was 54%. Clinically meaningful benefits were observed in NSCLC, HNSCC, and Hodgkin lymphoma. Both Hodgkin lymphoma patients had durable responses exceeding 19 months despite 12-16 prior lines of therapy. Mechanism Confirmation: Plinabulin triggered DC maturation post-RT via GEF-H1 signaling.
Flow cytometry of whole blood revealed increased expression of DC maturation markers and a shift in monocyte subpopulations from classical to proinflammatory phenotype in responders. Biomarker Insight: Single-cell RNA sequencing differentiated responders from non-responders and identified baseline GEF-H1 immune gene expression as a potential predictive biomarker for Plinabulin response.
