BeyondSpring Presents Promising Phase 2 Results for Pembrolizumab, Plinabulin, and Docetaxel in NSCLC Patients

BeyondSpring presented interim data from their Phase 2 303 Study at the 2025 ASCO, showing improved efficacy in metastatic NSCLC patients who have progressed after first-line PD-1/L1 inhibitors. The study demonstrated a median progression-free survival of 6.8 months, disease control rate of 77.3%, and a 15-month overall survival rate of 78%. Treatment with Plinabulin, pembrolizumab, and docetaxel showed promising results, with a high rate of adverse effects.

BeyondSpring Inc. (BYSI) has presented interim data from their Phase 2 303 Study at the 2025 ASCO, highlighting improved efficacy in metastatic non-small cell lung cancer (NSCLC) patients who have progressed after first-line PD-1/L1 inhibitors. The study, which enrolled 47 patients, demonstrated a median progression-free survival (PFS) of 6.8 months, a disease control rate (DCR) of 77.3%, and a 15-month overall survival (OS) rate of 78% [1].

The study evaluated the effectiveness of a triplet regimen comprising Plinabulin, pembrolizumab, and docetaxel in patients with metastatic NSCLC who have progressed on first-line PD-1/L1 inhibitors. The median PFS of 6.8 months nearly doubled the standard of care with docetaxel alone, indicating significant improvement in efficacy [1]. The DCR of 77.3% suggests that the majority of patients derive clinical benefit from the therapy after failing prior PD-1/L1 inhibitors [1].

In terms of overall survival, the 15-month OS rate of 78% is promising compared to the median OS of 11.8 months for the standard of care, suggesting enhanced long-term outcomes for patients [1]. The combination therapy was generally well tolerated, with 51.1% of patients experiencing grade 3 or higher treatment-related adverse effects, predominantly gastrointestinal side effects and transient hypertension, and no treatment-related fatalities reported [1].

BeyondSpring's CEO emphasized the potential of Plinabulin to address the challenge of acquired resistance to checkpoint inhibitors, aiming to provide new effective options for a patient population with limited alternatives [2]. The study highlights Plinabulin's potential as a first-in-class tubulin binder, capable of overcoming acquired resistance to checkpoint inhibitors via its dual innate and adaptive immune mechanism [1].

The study addresses a critical unmet need in lung cancer treatment, offering hope for patients who have developed resistance to first-line immunotherapy. The results suggest significant promise for NSCLC patients who have progressed after PD-1/L1 therapies, providing a new therapeutic path in managing this critical unmet need [1].

References:
[1] https://www.gurufocus.com/news/2904038/beyondspring-presents-efficacysafety-data-from-a-phase-2-study-of-pembrolizumab-plus-plinabulindocetaxel-in-metastatic-nsclc-after-progressing-on-firstline-immune-checkpoint-inhibitors-at-2025-asco
[2] https://www.nasdaq.com/articles/beyondspring-inc-reports-promising-interim-phase-2-data-plinabulin-metastatic-nsclc