BeyondSpring Updates Lung Cancer Study Data

BeyondSpring announced updated efficacy and safety data from the investigator-initiated Phase 2 303 Study evaluating pembrolizumab plus Plinabulin and docetaxel in patients with metastatic non-small cell lung cancer after progression on first-line immune checkpoint inhibitor therapy, either alone or in combination with chemotherapy. The data were presented at the 2026 American Society of Clinical Oncology, or ASCO, annual meeting. All patients had secondary resistance, defined as prior ICI treatment with progression-free survival of at least six months. Pembrolizumab (200 mg), Plinabulin and docetaxel were all dosed intravenously on day 1 of a 21-day cycle. As of the February 28 data cutoff, the median follow-up was 28.8 months. Three patients remained on treatment, and 24 patients remained alive in survival follow-up. Among the 47 enrolled patients, the median age was 67 years; 80.9% were male and 19.1% were female; 72.3% were current or former smokers; and histology included 63.8% non-squamous and 36.2% squamous NSCLC. The key results at the database lock are summarized below. Median progression-free survival of 7 months compared favorably with historical docetaxel data in similar post-ICI patient populations, including TROPION-Lung01 and EVOKE-01, which reported median PFS of 3.7 months and 3.9 months, respectively. Median duration of response of 9.3 months indicating durable response. Disease control rate of 79.5% indicating clinical benefit in the majority of patients who progressed on prior PD-1/L1 inhibitor-based therapy. Confirmed objective response rate of 18.2% compared favorably with historical 5-12% ORR for docetaxel, demonstrating anti-tumor activity in metastatic NSCLC patients with secondary resistance to prior ICI. Twelve-month overall survival rate of 78.1%; 24-month OS rate of 58%, with median OS not reached compared favorably with historical docetaxel data in similar patient populations, including TROPION-Lung01 and EVOKE-01, which reported median OS of 11.8 months and 9.8 months, respectively. The combination demonstrated a generally manageable safety profile. 53.2% of patients experienced grade 3 or higher treatment-related adverse events, including hypertension in 17%, gastrointestinal disorders in 14.9%, neutrophil decrease in 17%, decreased white blood cell count in 6.4%, and febrile neutropenia in 2.1%.