BeyondSpring Reports Significant Survival Improvement for Plinabulin in Asian NSCLC Patients
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 12 2025
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Should l Buy BYSI?
Source: Globenewswire
- Survival Rate Improvement: In a cohort of nearly 500 Asian patients, the Plinabulin plus docetaxel treatment group (DP) achieved an overall survival of 10.8 months compared to 8.8 months for docetaxel alone, with a hazard ratio of 0.81 and a p-value of 0.0426, indicating the drug's potential in EGFR wild-type non-small cell lung cancer (NSCLC) patients.
- Safety Advantage: Plinabulin significantly reduced the incidence of grade 4 neutropenia caused by docetaxel (DP: 3.9% vs. D: 26.5%, p<0.0001), which not only enhances patient tolerability but also may increase the efficacy of chemotherapy, thereby improving the overall treatment experience for patients.
- Mechanism Relevance: In the mechanism-aligned non-squamous subgroup, Plinabulin demonstrated a 3-month survival benefit (p=0.0064), indicating stronger efficacy of its immune-modulating and tumor vasculature-targeting mechanisms in specific patient populations, further solidifying its potential as a new standard of care.
- Global Study Advancement: BeyondSpring's CEO stated that these data bolster confidence in Plinabulin as a new standard treatment for EGFR wild-type NSCLC and will propel it into a global Phase 3 confirmatory study, showcasing the company's strategic positioning in the oncology field.
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Analyst Views on BYSI
About BYSI
BeyondSpring Inc. is a clinical-stage biopharmaceutical company. The Company is focused on developing therapies to improve clinical outcomes for patients with high unmet medical needs. Its lead asset, Plinabulin, is in late-stage clinical development as an anti-cancer agent in non-small cell lung cancer (NSCLC) and a range of cancer indications. The Company’s mechanism of action as a dendritic cell maturation agent supports both anti-cancer activity and immune modulation, offering an approach to resensitizing tumors to checkpoint inhibitors. It also has a pipeline of immuno-oncology product candidates, BPI-002 program, which is based on an oral small molecule agent that increases T-cell co-stimulation; BPI-003 program, which is based on a small molecule inhibitor of IKK, a protein kinase, and BPI-004 program, which is focused on a small molecule that induces the production of neo-antigens by tumor cells, allowing tumors containing no immune cells to be infiltrated by the immune system.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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BeyondSpring Reports Significant Survival Improvement for Plinabulin in Asian NSCLC Patients
- Survival Rate Improvement: In a cohort of nearly 500 Asian patients, the Plinabulin plus docetaxel treatment group (DP) achieved an overall survival of 10.8 months compared to 8.8 months for docetaxel alone, with a hazard ratio of 0.81 and a p-value of 0.0426, indicating the drug's potential in EGFR wild-type non-small cell lung cancer (NSCLC) patients.
- Safety Advantage: Plinabulin significantly reduced the incidence of grade 4 neutropenia caused by docetaxel (DP: 3.9% vs. D: 26.5%, p<0.0001), which not only enhances patient tolerability but also may increase the efficacy of chemotherapy, thereby improving the overall treatment experience for patients.
- Mechanism Relevance: In the mechanism-aligned non-squamous subgroup, Plinabulin demonstrated a 3-month survival benefit (p=0.0064), indicating stronger efficacy of its immune-modulating and tumor vasculature-targeting mechanisms in specific patient populations, further solidifying its potential as a new standard of care.
- Global Study Advancement: BeyondSpring's CEO stated that these data bolster confidence in Plinabulin as a new standard treatment for EGFR wild-type NSCLC and will propel it into a global Phase 3 confirmatory study, showcasing the company's strategic positioning in the oncology field.
See More
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- Safety Profile Enhancement: Plinabulin markedly reduced the incidence of grade 4 neutropenia caused by docetaxel (3.9% vs. 26.5%), which not only improves patient tolerability but also may enhance the overall efficacy of chemotherapy, further solidifying its potential as a new standard of care.
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- Stock Price Rebound: Following the announcement, ZIM's shares rose 7.6% in pre-market trading to $21.38, reflecting market optimism about the company's future prospects and potentially attracting more investor interest.
- Enhanced Strategic Value: By actively assessing acquisition proposals, ZIM not only strengthens its market position but also may achieve operational efficiencies through resource integration, thereby delivering higher returns to shareholders.
- Positive Market Reaction: The stock price increase indicates investor confidence in ZIM's potential acquisitions, which could further boost the company's competitiveness and market share in the shipping industry.
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- Survival Rate Improvement: In a cohort of nearly 500 Asian patients, the Plinabulin plus docetaxel treatment group (DP) achieved an overall survival of 10.8 months compared to 8.8 months for docetaxel alone, with a hazard ratio of 0.81 and a p-value of 0.0426, indicating the drug's potential in EGFR wild-type non-small cell lung cancer (NSCLC) patients.
- Safety Advantage: Plinabulin significantly reduced the incidence of grade 4 neutropenia caused by docetaxel (DP: 3.9% vs. D: 26.5%, p<0.0001), which not only enhances patient tolerability but also may increase the efficacy of chemotherapy, thereby improving the overall treatment experience for patients.
- Mechanism Relevance: In the mechanism-aligned non-squamous subgroup, Plinabulin demonstrated a 3-month survival benefit (p=0.0064), indicating stronger efficacy of its immune-modulating and tumor vasculature-targeting mechanisms in specific patient populations, further solidifying its potential as a new standard of care.
- Global Study Advancement: BeyondSpring's CEO stated that these data bolster confidence in Plinabulin as a new standard treatment for EGFR wild-type NSCLC and will propel it into a global Phase 3 confirmatory study, showcasing the company's strategic positioning in the oncology field.
See More
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- Significant Survival Improvement: In a cohort of 488 Asian patients, the combination of Plinabulin and docetaxel achieved an overall survival of 10.8 months compared to 8.8 months for docetaxel alone, indicating a potential advantage for this therapy in EGFR wild-type non-small cell lung cancer patients.
- Safety Profile Enhancement: Plinabulin markedly reduced the incidence of grade 4 neutropenia caused by docetaxel (3.9% vs. 26.5%), which not only improves patient tolerability but also may enhance the overall efficacy of chemotherapy, further solidifying its potential as a new standard of care.
- Mechanism-Related Survival Benefits: In the non-squamous subgroup, Plinabulin demonstrated a hazard ratio of 0.69, indicating a 3-month survival benefit, highlighting the alignment of its immune-modulating mechanism with tumor biology, potentially offering better treatment outcomes for patients.
- Global Research Validation: These findings further strengthen the global evidence supporting Plinabulin as a new standard treatment for EGFR wild-type non-small cell lung cancer, with BeyondSpring planning to advance it into a global Phase 3 confirmatory study, showcasing the company's confidence and commitment to this therapy.
See More
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- Significant Survival Improvement: In the DUBLIN-3 study, the combination of Plinabulin and docetaxel achieved a median overall survival (OS) of 15.8 months, compared to 11.7 months for docetaxel alone, indicating a potential advantage for this therapy in patients who progressed after anti-PD-(L)1 treatment.
- Progression-Free Survival Enhancement: The combination therapy demonstrated a median progression-free survival (PFS) of 5.6 months, while docetaxel alone showed only 3.8 months, highlighting Plinabulin's effectiveness in delaying disease progression and addressing a critical unmet need in this patient population.
- Reduced Incidence of Brain Metastases: The incidence of new brain metastases was 4.32% in the Plinabulin group versus 7.83% in the docetaxel group, underscoring Plinabulin's brain-penetrant properties and its potential to offer new treatment options for patients with brain metastases.
- Improved Safety Profile: Plinabulin significantly reduced the incidence of grade 4 neutropenia caused by docetaxel from 33.58% to 5.13%, which not only enhances patient tolerability but may also facilitate prolonged treatment duration, thereby improving clinical outcomes.
See More
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- Progression-Free Survival Enhancement: The combination therapy achieved a median progression-free survival (PFS) of 5.6 months compared to 3.8 months for docetaxel alone, indicating Plinabulin's potential in combating tumor recurrence, which could shift clinical treatment paradigms.
- Reduced Incidence of Brain Metastases: The incidence of new brain metastases was reduced to 4.32% with Plinabulin combination therapy, significantly lower than the 7.83% observed with docetaxel, suggesting its potential advantages in brain tumor treatment and better patient prognosis.
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See More
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See More
