FLORHAM PARK, N.J. - BeyondSpring Inc. (NASDAQ: BYSI), a clinical-stage biopharmaceutical company, announced interim results from its phase 2 study of a novel treatment regimen for non-small cell lung cancer (NSCLC) at the European Society for Medical Oncology (ESMO) Congress in Barcelona, Spain, on September 14, 2024. The study, known as KeyPelms-004 or 303 Study, is evaluating the efficacy and safety of combining pembrolizumab with plinabulin and docetaxel in patients who have shown disease progression after first-line therapy with immune checkpoint inhibitors.
The study, which is being conducted at Peking Union Medical College Hospital in Beijing, China, under the leadership of Dr. Mengzhao Wang, has enrolled 29 patients as of April 29, 2024, with 19 being evaluable for the interim analysis. The primary endpoint of the study is the objective response rate (ORR), which stood at 21.1% for the triple combination therapy. The median progression-free survival (PFS) was reported to be 8.63 months, with a 6-month PFS rate of 67.1% and a 12-month rate of 49.2%. The median duration of response (DoR) was 11.40 months, and the disease control rate (DCR) was 89.5%.
The interim data suggest that the triple combination therapy could potentially double the median PFS compared to historical controls, which is considered a significant improvement for patients with this severe unmet medical need. The study's safety profile was also deemed acceptable, with 52.6% of patients experiencing grade 3 or higher treatment-related adverse effects, but no treatment-related deaths were reported.
Plinabulin, BeyondSpring’s lead asset, is a novel first-in-class dendritic cell maturation therapeutic that has been observed to have durable anti-cancer benefits across multiple clinical studies. It is designed to reinforce anti-tumor immune response and potentially overcome acquired resistance to immune checkpoint inhibitors.
The 303 Study is ongoing and aims to enroll a total of 47 patients. It is financially supported by Merck & Co., Inc. (NYSE: MRK), which also provided the study drug through its Investigator Studies Program. This information is based on a press release statement from BeyondSpring Inc.
InvestingPro Insights
BeyondSpring Inc. (NASDAQ: BYSI) has shown promising results in its latest clinical study, and investors are closely monitoring the company's financial health and market performance. According to InvestingPro, BeyondSpring holds more cash than debt on its balance sheet, which is a positive sign for the company's financial stability. This could be particularly relevant for investors considering the potential costs associated with the ongoing development and clinical trials of new treatments.
InvestingPro data highlights a significant return over the last week with a 13.58% increase in price total return, and an even more impressive year-to-date price total return of 155.56%. This suggests a strong investor confidence in the company's prospects, possibly buoyed by the recent clinical study announcements. However, analysts do not anticipate the company will be profitable this year, which is a consideration for those looking at the longer-term earning potential of BeyondSpring.
The company's market capitalization stands at $92.69 million, and while the revenue has grown by 21.03% over the last twelve months as of Q2 2024, it is important to note that BeyondSpring is trading at a high revenue valuation multiple. This could indicate that the stock is priced optimistically relative to its actual revenue generation, a factor that investors should weigh against the clinical success and potential market for its treatments.
For investors seeking more detailed analysis and additional insights, there are 11 more InvestingPro Tips available for BeyondSpring Inc. at https://www.investing.com/pro/BYSI. These tips can provide a deeper understanding of the company's financial nuances and market position, helping to inform investment decisions.
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