BeyondSpring Presents Final Data Analysis of DUBLIN-3 Phase 3 Study in 2L/3L EGFR Wild-type NSCLC at ESMO Congress 2024
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Sep 16 2024
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Should l Buy BYSI?
Source: Newsfilter
Dublin-3 Study Findings: BeyondSpring Inc. presented final data from the Dublin-3 study at ESMO Congress 2024, showing that the combination of plinabulin and docetaxel significantly improved overall survival and reduced severe neutropenia in patients with EGFR wild-type NSCLC compared to docetaxel alone.
Safety and Quality of Life Improvements: The combination therapy was well tolerated, with fewer grade 4 treatment-emergent adverse events and a notable improvement in quality of life, suggesting it could be a new treatment option for patients who have not responded to standard therapies.
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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.
BeyondSpring to Present at IO360° Conference 2026
- Conference Participation: BeyondSpring will participate in the Immuno-Oncology 360° Conference from February 10-12, 2026, in Boston, showcasing its latest advancements in cancer immunotherapy to enhance its visibility and influence in the biopharmaceutical industry.
- Leadership Presentation: Dr. Lan Huang, Co-Founder and CEO, will present on Plinabulin on February 11 from 4:55 PM to 5:10 PM, highlighting its unique mechanism and clinical development strategy, which is expected to attract attention from investors and industry experts.
- Innovative Mechanism: Plinabulin, as a dendritic cell maturation agent, is in late-stage clinical development targeting high unmet medical needs in indications like non-small cell lung cancer, demonstrating its potential in cancer treatment.
- Post-Presentation Materials: Following the presentation, the slides will be available on the company's website under the
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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.
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- 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.
- 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 prolong treatment duration, thereby improving clinical outcomes.
See More
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- Leadership Presentation: Dr. Lan Huang, Co-Founder and CEO, will present on Plinabulin on February 11 from 4:55 PM to 5:10 PM, highlighting its unique mechanism and clinical development strategy, which is expected to attract attention from investors and industry experts.
- Innovative Mechanism: Plinabulin, as a dendritic cell maturation agent, is in late-stage clinical development targeting high unmet medical needs in indications like non-small cell lung cancer, demonstrating its potential in cancer treatment.
- Post-Presentation Materials: Following the presentation, the slides will be available on the company's website under the
See More
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- Surge in Acquisition Proposals: ZIM Integrated Shipping has received multiple competitive acquisition proposals during its strategic review, with the board evaluating these offers to create significant value for shareholders, which is expected to enhance the company's market appeal.
- 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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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
BeyondSpring Reports Plinabulin Asian Trial Data, Survival Extended to 10.8 Months
- 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
BeyondSpring Reports Plinabulin Clinical Data, OS Increased to 15.8 Months
- 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
BeyondSpring Reports Plinabulin Clinical Data, OS Improved to 15.8 Months
- Significant Survival Improvement: In the DUBLIN-3 study, the combination of Plinabulin and docetaxel improved median overall survival (OS) from 11.7 months to 15.8 months for non-squamous EGFR WT NSCLC patients, demonstrating its survival benefits in a population with high unmet medical needs following anti-PD-(L)1 therapy.
- 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.
- 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 prolong treatment duration, thereby improving clinical outcomes.
See More
