FLORHAM PARK, N.J. – BeyondSpring Inc. (NASDAQ: BYSI), a biopharmaceutical company, announced at the European Society for Medical Oncology (ESMO) Congress 2024 that its latest Phase 3 trial, the DUBLIN-3 study, shows a new treatment combination for non-small cell lung cancer (NSCLC) could offer a safer alternative to the current standard of care. The study results, which were also published in the Lancet Respiratory Medicine on September 9, 2024, indicate that the combination of plinabulin and docetaxel significantly improves patient outcomes compared to docetaxel alone.
The DUBLIN-3 study, a multicenter, single-blinded, randomized controlled trial, enrolled 559 patients with EGFR wild-type NSCLC across 58 medical centers in Australia, China, and the USA. Participants received either the combination of plinabulin and docetaxel or docetaxel with a placebo. The findings highlighted that the plinabulin/docetaxel combination led to a significant improvement in overall survival, progression-free survival, and objective response rate.
Safety outcomes, the focus of the ESMO presentation, showed that the combination therapy was well tolerated with similar rates of treatment emergent adverse events in both treatment arms. Notably, there was an over 80% relative reduction in Grade 4 neutropenia, a severe side effect of chemotherapy that can lead to hospital admissions due to febrile neutropenia. The combination treatment also resulted in a reduced use of granulocyte-colony stimulating factor, a medication used to combat neutropenia.
Quality of life, as measured by the Quality-Adjusted Time Without Symptoms or Toxicity (Q-TWiST) method, also improved in the plinabulin/docetaxel arm. Additionally, the combination therapy showed a significant reduction in cycle-adjusted serious adverse events.
Plinabulin, BeyondSpring’s first-in-class lead asset, is a dendritic cell maturation agent that has been administered to over 700 patients with good tolerability. The clinical data suggests that plinabulin not only has a direct anti-cancer benefit but also enhances the cancer immunity cycle and significantly reduces chemotherapy-induced neutropenia.
Dr. Trevor M. Feinstein, one of the lead principal investigators of the DUBLIN-3 study, stated that for NSCLC patients without targetable alterations, the phase 3 data suggests a favorable benefit/risk ratio for the plinabulin/docetaxel combination compared to docetaxel alone. This could represent a new treatment option for second or third-line NSCLC patients, addressing a severe unmet medical need.
BeyondSpring is dedicated to developing innovative therapies to improve clinical outcomes for patients facing high unmet medical needs. This recent study’s findings are based on a press release statement from the company.
In other recent news, BeyondSpring Inc. reported promising interim results from its phase 2 study of a novel treatment regimen for non-small cell lung cancer (NSCLC). The study, known as KeyPelms-004 or 303 Study, is evaluating the efficacy and safety of combining pembrolizumab with plinabulin and docetaxel. The interim analysis of the study, conducted at Peking Union Medical College Hospital, revealed an objective response rate of 21.1% for the triple combination therapy. The median progression-free survival was reported to be 8.63 months, suggesting a potential doubling of the median PFS compared to historical controls.
The study’s safety profile was deemed acceptable, with no treatment-related deaths reported. The company’s lead asset, Plinabulin, is being used in this study, which is financially supported by Merck & Co., Inc. that also provided the study drug. The 303 Study is ongoing, aiming to enroll a total of 47 patients. These are among the recent developments concerning BeyondSpring Inc. and its endeavors in the medical field.
InvestingPro Insights
As BeyondSpring Inc. (NASDAQ: BYSI) presents promising clinical trial results for its NSCLC treatment, InvestingPro data and insights offer a deeper look at the company’s financial health and market performance. BeyondSpring’s market capitalization currently stands at 92.69 million , reflecting the market’s valuation of the company. Despite the potential clinical advancements, analysts have concerns about the company’s profitability, noting that net income is expected to drop this year and the company is not anticipated to be profitable within the year.
InvestingPro Tips indicate that BeyondSpring holds more cash than debt on its balance sheet, which could provide financial stability as it continues its clinical developments. However, the company’s stock is considered to be in overbought territory according to the Relative Strength Index (RSI), suggesting that its recent price increases may be due for a correction.
On the performance front, the company has seen a significant return over the last week, with a 13.58% price total return, and an even more impressive year-to-date price total return of 155.56%. These figures highlight the stock’s recent positive momentum, which could be in response to the clinical trial outcomes and other factors.
For those interested in further insights and data, InvestingPro offers additional tips on BeyondSpring Inc., which can be accessed at https://www.investing.com/pro/BYSI. With these resources, investors can make more informed decisions regarding their interest in BeyondSpring as it navigates the competitive biopharmaceutical landscape.
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