BeyondSpring shares Phase 2 lung cancer data showing survival benefit

BeyondSpring (NASDAQ:BYSI) announced updated data from an investigator-initiated Phase 2 clinical trial evaluating a triple-combination therapy for patients with advanced lung cancer, demonstrating sustained overall survival and disease control in a difficult-to-treat population.

The open-label Study 303 evaluated the efficacy and safety of the company's lead asset, plinabulin, in combination with the immunotherapy pembrolizumab and the chemotherapy agent docetaxel.

The trial enrolled 47 patients diagnosed with metastatic non-small cell lung cancer (NSCLC) whose disease had progressed after receiving first-line immune checkpoint inhibitor treatments, either as a standalone therapy or alongside platinum-doublet chemotherapy.

Among the 47 patients evaluated, the combination regimen yielded a median progression-free survival of 7 months and a median duration of response of 9.3 months.

The trial recorded an overall disease control rate of 79.5% and a confirmed objective response rate of 18.2%.

Longitudinal survival measurements showed a 12-month overall survival rate of 78.1% and a 24-month overall survival rate of 58%, while the median overall survival metric has not yet been reached.

Management indicated that the safety profile of the triple therapy remained manageable.

The underlying mechanism of plinabulin, a small-molecule immune-enhancing agent designed to trigger dendritic cell maturation and anti-tumor T-cell responses, correlated with increased post-treatment frequencies of activated CD4+ and CD8+ T cells.

Additionally, hematological evaluations demonstrated safety benefits, revealing higher relative levels of white blood cells, neutrophils, and platelets, which help offset typical chemotherapy-induced toxicities.