On June 2, 2026 BeyondSpring Inc. (NASDAQ: BYSI) ("BeyondSpring" or the "Company"), a clinical-stage company developing transformative therapies for the treatment of cancer and other diseases, reported 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 ("NSCLC") after progression on first-line immune checkpoint inhibitor ("ICI") therapy, either alone or in combination with chemotherapy. The data were presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting by Dr. Mengzhao Wang and Dr. Yan Xu, principal investigators from Peking Union Hospital.

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First-in-class small molecule agent Plinabulin is a brain-penetrant, uniquely reversible tubulin binder with immunomodulatory properties that promote dendritic cell maturation, M1 polarization and anti-tumor T-cell responses. As a GEF-H1 agonist, Plinabulin is designed to strengthen the cancer-immunity cycle, support immune activation, and help address chemotherapy-induced neutropenia, providing a potential differentiated approach in the post-ICI treatment setting.

The open-label Phase 2 study enrolled 47 patients with metastatic NSCLC who had progressed following prior ICI therapy, including 6 patients previously treated with ICI alone and 41 patients previously treated with ICI plus platinum-doublet chemotherapy. All patients had secondary resistance, defined as prior ICI treatment with progression-free survival of at least six months. Pembrolizumab (200 mg), Plinabulin (30 mg/m2) and docetaxel (75 mg/m2) were all dosed intravenously on day 1 of a 21-day cycle.

As of the February 28, 2026 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 (PFS): 7.0 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 (DoR): 9.3 months – indicating durable response
Disease Control Rate (DCR: PR + SD > 4 months): 79.5% — indicating clinical benefit in the majority of patients who progressed on prior PD-1/L1 inhibitor-based therapy
Confirmed Objective Response Rate (ORR): 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
12-Month Overall Survival (OS) Rate: 78.1%; 24-Month OS Rate: 58.0%, 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 17.0%, gastrointestinal disorders in 14.9%, neutrophil decrease in 17.0%, decreased white blood cell count in 6.4%, and febrile neutropenia in 2.1%
"These updates continue to support Plinabulin’s potential to address one of the most significant unmet needs in lung cancer: treatment options for patients whose disease has progressed after ICI therapy," said Dr. Mengzhao Wang, principal investigator from Peking Union Hospital in China. "With 24-month OS rate of 58%, together with 80% of disease control and encouraging immune activation and hematologic benefit, we believe Plinabulin may offer a differentiated approach to re-sensitizing tumors to immunotherapy with durable long-term benefit while improving the therapeutic profile of docetaxel-based regimens."

BeyondSpring’s ASCO (Free ASCO Whitepaper) 2026 Presentation

Title: A Phase 2 Study of Plinabulin (Plin)/Docetaxel (Doc) plus Pembrolizumab (Pemb) in Metastatic NSCLC (mNSCLC) After Acquired Resistance (AR) to Anti-PD-1/L1 Alone or in Chemotherapy Combination: Efficacy and Immunophenotyping
Presenter/Authors: Yan Xu, Minjiang Chen, Xiaoxing Gao, Huiyu Huang, Yue Chang, Xiaoyan Liu, Wei Zhong, Jing Zhao, RuiLi Pan, Taisheng Li, Mengzhao Wang
Session: Lung Cancer – Non-Small Cell Metastatic (Track)
Abstract Number: 8567

(Press release, BeyondSpring Pharmaceuticals, JUN 2, 2026, View Source [SID1234666399])